Speakers

A collaborative, strategic professional with a highly result oriented and problem-solving mind. Almost 17 years of regulatory affairs practice and efficient training courses gave him a solid and enriched knowledge in different regulatory aspects in terms of registration of medicinal products; GSL products and medical devices, Marketing authorization functions, post approval changes and renewal process. His core strengths and competencies are building new Regulatory departments and leading cross functional team as well as developing creative regulatory solutions that reflect on achieving the company organizational commercial targets and business objectives successfully.

Dr. Rawya is a clinical pharmacist with broad Medical and Pharmaceutical knowledge, experience in various aspects of the Pharmaceutical Industry especially Medical Affairs, Regulatory Affairs and Pharmacovigilance, as well as knowledge and experience in the research field. She has a M.Sc. Clinical Pharmacy (with Distinction) – Queen’s University, UK.
Dr. Rawya began her career at Hikma Pharmaceuticals, Jordan since 1998 till 1999, and she is currently the Regulatory Affairs & Medical Affairs Director at Gulf Pharmaceutical Industries (Julphar), Ras Al Khaimah, United Arab Emirates since 2020 – to the present date.
In her role in Regulatory affairs, she displays and actions leadership in all aspects of Regulatory Affairs for company product portfolio of generics and novel products, including product development and submissions.
She is also an expert in defining the strategic regulatory direction for pipeline development and global launch excellence for a significant dedicated R&D budget. In addition, Dr. Rawya is knowledgeable of partnering with R&D and Global Strategic Marketing leaders as well another functional leader to develop and implement strategy for pipeline development and global launch excellence.

Samar Abdalhalim graduated with a bachelor’s degree in Pharmaceutical Sciences in 2007.
With over 15 years of dedicated experience in the pharmaceutical and personal healthcare industry, Dr. Samar Abdalhalim has had the privilege of making significant contributions to the regulatory field. She has been at the forefront of shaping the regulatory landscape and ensuring compliance within the P&G Health organization.
Dr. Samar Abdalhalim has held various positions at leading companies such as Hospira-Pfizer and Johnson & Johnson, where she honed her expertise in regulatory affairs, regulatory intelligence, and strategic planning.

Currently, he is the Regulatory Affairs Lead in Acino, based in Cairo Egypt, managing Gulf.
Dr. Khaled has more than 18 years’ experience in Regulatory Affairs in different region; GCC, Middle East, & Africa.
He started his career in 2002 in Manufacturing Quality Assurance & Validation.
Then he has shifted to Regulatory Affairs since 2006 & he has been working among many local & multinational companies such as Novartis & Pfizer until joining Acino in 2019.

Dr. Darweish obtained her Bachelor of Pharmacy in 2006 and a Master’s in Pharmaceutical Technology in 2010 from the University of Jordan, specializing in the Development and Response Surface Optimization of extended-release dosage form. With over 18 years of extensive experience in the pharmaceutical sector, her expertise lies predominantly in Research and Development across various pharmaceutical dosage forms. This encompasses pre-formulation, formulation, optimization, development, and scale-up processes to ensure formulations’ stability, bioequivalence, manufacturing, efficacy, and safety.
Dr. Darweish is presently serving as the Corporate Research and Development Manager at Tabuk Pharmaceutical Company.

With a keen eye for detail and a strong history in defense industry bid management, Dolcinea took up the role of Business Development Director with AAICO at the end of 2022, as they relocated their global HQ to Abu Dhabi. At AAICO she leverages her passion for innovation and emerging technologies to successfully drive growth across various verticals.
Dolcinea holds a Masters Degree in Law and a Bachelor of Arts in Communication, which brings a unique perspective to her role. Known for her approachable nature and collaborative spirit, Dolcinea is dedicated to taking others on the journey of discovering the power of artificial intelligence in healthcare.

Meet Gorkem, a dedicated International Marketing Manager at VISIOTT, specializing in Track and Trace solutions and Vision Inspection systems. With a fervent enthusiasm for data analytics and international trade, he thrives in fostering global partnerships and driving tangible results. He brings a wealth of experience to his role and is committed to pushing the boundaries of innovation in his field.

Shatha Safi, a Labelling Supervisor who joined the Regulatory Affairs Department at Hikma Pharmaceuticals in 2015. In her current role, she is responsible for the Labelling Unit, where she manages the coordination, planning, and implementation of Labelling activities for Hikma’s products throughout their lifecycle in diverse geographies in the Levant and GCC regions. She also has hands-on experience and a proven track record in Project Management and Business Process Automation.

A pharmaceutical industry executive with more than 19 years of experience in both public and private Pharmaceutical Sector. Pharmacist by education, obtained master’s degree in public policy from the American University in Cairo

Led key initiatives in development and implementation of pharmaceutical regulations, planning and implementation of Health system reforms, and shaping regulatory policy. Working in a company specialized in Women Health innovation, she is also aspired to lead in regulatory and policy shaping for innovative health solutions and digital transformation of pharmaceutical industry.
She was a former General Director of Health products and Biopharmaceutics Registration Department, represented the Egyptian Drug Authority in regional and international scientific and policy discussions with Health Agencies and WHO. Held other several key positions in the public pharmaceutical sector such as Director for the Pharmaceutical Supply Reform National Program and Policy Technical Office Director.
She led and coached big teams, taught pharmaceutical policy and regulations and mentored large number of young professionals to accomplish and grow.
Innovation Ambassador, Women in STEM Advocate and mentor.
Founder in STEM her Up, STEM mentoring foundation for women and girls in Egypt.

Shine Vijayan is a highly experienced technology and business professional with a passion for building exceptional hardware and software products. With over 22 years of industry experience in product and senior engineering leadership roles, Shine Vijayan has developed a deep understanding of the intersection between technology and business practices.
Areas of Expertise:
With expertise spanning the entire hardware design and software development life-cycle, Shine Vijayan possesses a comprehensive skill set that includes proficiency in numerous programming languages and a strong background in agile product delivery. His technical knowledge is complemented by a keen interest in the impact of technology trends on global business practices, allowing them to provide valuable insights into the evolving landscape of technology and its implications for businesses.
Product Management and Strategy:
As a product management professional, Shine Vijayan specializes in strategic planning, product development, and project management. He possesses a unique ability to balance strategic thinking with execution excellence, enabling them to identify and address customer pain points effectively. By leveraging its expertise in portfolio strategy, Shine Vijayan excels at shipping great products that not only meet customer expectations but also delight them. His current focus on product management allows the organisation to effectively bridge the gap between business, engineering, and customer experience.
Leadership and Team Development:
Having held senior engineering leadership roles, Shine Vijayan has honed his skills in team development, fostering collaboration, and driving innovation within cross-functional teams. He understands the importance of cultivating a cohesive and motivated team to achieve business objectives successfully.
Passion: Shine Vijayan is deeply interested in the impact of technology trends on global business practices. He constantly strives to understand customer pain points and provide meaningful solutions to address them. He has a good balance of strategic thinking, understanding the “what” and “why,” along with execution excellence, knowing “how” to deliver results.
Passion: Shine Vijayan is deeply interested in the impact of technology trends on global business practices. He constantly strives to understand customer pain points and provide meaningful solutions to address them. He has a good balance of strategic thinking, understanding the “what” and “why,” along with execution excellence, knowing “how” to deliver results.
Skills:
Product Management: Shine Vijayan has a strong background in product management, leveraging their expertise to drive successful product development.
Strategic Planning: He excels in developing strategic plans that align with business objectives and technology trends.
Product Development: With his extensive experience, they have a keen understanding of the product development process, from ideation to launch.
Project Management: Shine Vijayan possesses excellent project management skills, ensuring projects are delivered on time and within budget.
Team Development: He has a talent for fostering team growth and development, building high-performing teams.
Portfolio Strategy: Shine Vijayan is skilled in developing and implementing portfolio strategies to maximize product success.
Shipping Great Products: He is a track record of delivering high-quality products that delight customers.
Data & Metrics: Shine Vijayan understands the importance of data and metrics in driving informed decision-making and achieving business goals.

An Indian, who continues to be captivated by the vibrance of UAE for the past 20+ years.
Education: Bachelor in Ayurvedic (alternative) medicine from Rajiv Gandhi University of Health Science, Bangalore, India/ MBA in Quality management system from Geneva Business School, Switzerland/ Advance certificate in regulatory affairs from San Diego State university, USA.
20 years of experience in the pharmaceutical industry, including sales and regulatory roles.
Job Profile summary:
Develop and implement regulatory strategies, ensure compliance and continuous access of innovative medicine to patients, within the GEM & Africa cluster, a region with diverse, complex, and rapidly evolving regulatory environment.
Developing external partnerships and building positive relationships with internal cross-functional teams to strategize, execute and drive business growth.
Achievement:
Personal: Becoming the best buddy of my two teenage boys
Professional: Core team member “Regional Distribution Network”, Licensing BMS distribution hub in Dubai,
BMS scientific office licensing.
Core team member “Project Fusion” – process & system integration following company acquisition.
Representing BMS as country network participant in the TransCelerate initiative (TransCelerate initiatives are a long-term industry collaborative effort to design, develop and deliver solutions for more efficient R&D).
My Life’s Mantra: “EKAM SATH, VIPRA BAHUDA VADANTI” – Truth is one, its interpretations are many.

Dr. Yousra is a Regulatory Affairs and Commercial & Distribution Quality Assurance Director, Strategic Project Lead with over 18 years of diversified experience from various leadership positions in Regulatory Affairs , Quality Assurance within Health Authority as well as multinational organizations at both regional and local levels.
Dr. Yousra is currently leading Abbott-Gulf, Levant & Emerging Markets Regulatory Affairs, Quality Assurance and Strategic Projects. In her role in Abbott Established Pharmaceutical Division; Yousra is responsible for setting Regulatory Strategies for New Product Introduction, Geo-expansion, Licensing & Acquisition, Localization, Life cycle management, enhancement of promotional model, as well as Regulatory risk mitigation and regulatory compliance.
Dr. Yousra has set effective regulatory strategies of external engagement including Health authorities, local distributors, trade associations and Third-Party Manufacturers. This is in addition to her Quality Assurance responsibilities of establishing and embedding Quality Management System within GEM & Levant.
On top of that, she set the base for strategic projects within the Gulf & Emerging Markets and lead the execution of a variety of initiatives that support patient centricity.
Dr. Yousra is holding a bachelor of pharmaceutical sciences from Cairo University and RAPS-DPC certification/USA-UAE and She has also completed the “New Leadership Program (NLP)”, by Harvard Business School and is currently enrolled in “Professional Diploma in Business Planning and Strategy”, by Rochester Institute of Technology, USA.

Regulatory Affairs Director & Strategic Business Partner for Middle East, Turkey, Pakistan, and CIS, META HUB – ELI Lilly and Company.
He holds a bachelor’s degree in Pharmaceutical Science from Alexandria University Egypt in 2002, as well as a US equivalency from the National Association of Boards of Pharmacy in 2008 same. He has more than 20 years of experience in multinational companies such as MSD, GSK, Novartis, and Lilly, working across different regions such as Egypt, Gulf and US.
He has a strong passion for regulatory affairs, where he spent 15 years of his career. He also led the Regulatory Affairs Working Group Gulf for four years and was involved in the organizing committee, as well as a speaker and moderator, in several DIA meetings. He is a proud father of three children, the eldest of whom is studying pharmacy in the US.

Ingenious Quality Leader with over 23 years of profound GxP experience in sterile/nonsterile pharmaceutical and medical device within the context of Technical Ops, Manufacturing, CMO, Distribution and Commercial operations including over 12 years in a leadership position in multinational business culture. His experience spans across North America, EMEA and China.
He had a track record of leveraging multidisciplinary teamwork to establish and sustain a fit for purpose risk based QMS in accordance with USFDA, EU, Health Canada, and GCC regulations for sites globally. He was keen on fostering a culture of Data Integrity compliance and achieving corporate compliance governance which resulted in outstanding regulators inspection outcomes.

At a Global role, Mr. Mazen played a pivotal role in driving various business initiatives such as Pharma 4.0 and governance compliance programs, leveraging his strengths in risk-based critical thinking, problem-solving, and proactive process control.
His leadership has led to quality transformations and seamless integration of new acquisitions worldwide, showcasing his precision and efficiency in executing strategic initiatives. Further, he deployed operational excellence utilizing lean manufacturing principles and kaizen tools, which optimized processes, reduced product defects, and positively impacted the bottom line, while upholding stringent quality standards.
A hallmark of Mr. Mazen’s career is his distinctive collaborative leadership style, forward-thinking mindset, integrity, unwavering commitment to continuous improvement and recognition as a change agent characterized by agility and resilience.  These attributes have established him as a respected professional in the industry.

Jihad Tayara is an accomplished executive in ICT & Digital Transformation with proven track record of delivering on P&L ambitions. He is also an expert in leading, closing and delivering on complex deals, PPPs & large government engagements in Infrastructure, ICT, Smart City services and cloud platforms like Dubai Pulse with Digital Dubai, Hassantuk with the Ministry of Interior and Tatmeen, the nationwide track and trace project with the Ministry of Health and Preventions.
He is currently the CEO of EVOTEQ, a Digital Transformation leader based in the UAE and a member of Young President Organization – YPO, sits on the board of YPO Emirates Chapter and on the Advisory board of the Canadian University in Dubai.
With a career spanning more than 28 years of Telecom and Technology with Investcom, Motorola & du before joining EVOTEQ, Jihad is a Computer Engineer by training and holds an MBA from Cambridge in the UK.

Dr. Haidy Saad, a distinguished Global Regulatory Affairs leader, has carved an extraordinary career path over the span of two decades, leaving an indelible mark on the global pharmaceutical landscape. Dr. Saad’s unwavering commitment to advancing healthcare and shaping regulatory policies across diverse geographies and therapeutic categories has established her as a respected figure in the industry.
In November 2016, Dr. Haidy Saad commenced her illustrious journey with Novartis Pharmaceuticals Corp., assuming the role of Head of Regulatory/Corporate Affairs for the Middle East and Gulf Cluster. Her strategic acumen played a pivotal role in overseeing a portfolio with a substantial value of approximately $400 million. Dr. Saad’s external focus was instrumental in establishing Novartis Pharmaceuticals Corp. as the healthcare partner of choice, fostering key stakeholder relationships, and supporting business strategy and launch plans.
Dr. Haidy Saad’s tenure at Novartis was characterized by her adeptness in developing and executing corporate affairs and advocacy plans, aligning them seamlessly with business objectives. Her collaborative efforts with cross-functional teams resulted in the creation of impactful corporate affairs strategies that resonated with the company’s vision and goals.
From March 2021 to March 2023, Dr. Haidy Saad assumed the role of RAWG Chairwoman at PHARMAG, a subsidiary of Pharma MEA. In this prestigious position, she represented approximately 26 innovative pharmaceutical and consumer healthcare companies. Dr. Saad’s leadership was instrumental in partnering with regional healthcare systems to shape policies, build capabilities, and ensure expedited patient access to innovative medicines. Her efforts significantly contributed to the development of best-in-class healthcare ecosystems.
A trailblazer in policy shaping and regulatory intelligence, Dr. Haidy Saad has been at the forefront of monitoring new legislations and engaging with public stakeholders. Her lobbying efforts with Health Authorities and external decision-makers have been pivotal in achieving corporate goals. Dr. Saad has not only shaped the external regulatory environment but also cultivated extensive networks within industry groups, further solidifying her reputation as a thought leader in the field.
A trailblazer in policy shaping and regulatory intelligence, Dr. Haidy Saad has been at the forefront of monitoring new legislations and engaging with public stakeholders. Her lobbying efforts with Health Authorities and external decision-makers have been pivotal in achieving corporate goals. Dr. Saad has not only shaped the external regulatory environment but also cultivated extensive networks within industry groups, further solidifying her reputation as a thought leader in the field.
Dr. Haidy Saad’s biography reflects a remarkable journey of leadership, innovation, and dedication to advancing healthcare globally. Her impact on regulatory affairs, policy shaping, and corporate advocacy has left an enduring legacy, earning her a place among the influential figures in the pharmaceutical industry.

Strong Pharmaceutical industry professional with 14+ years of experience within different multinational companies covering Regulatory, Medical, Market Access and Corporate Affairs & Communications across different dynamic regions including Middle East & Africa.
Patient-oriented and results driven, she has been a strong team player in different projects by shaping the appropriate environment leading to business expansion in a fastest and safer manner to help patients getting access to innovative products.

Helene Sou is a Director in Global Regulatory Policy and Innovation, focused on the Growth and Emerging Markets region in Takeda and currently based in Singapore.
Helene has 19 years of experience in international regulatory affairs gained through country, regional and global regulatory roles.
In the early part of her career, Helene worked several years as an EU Regulatory Consultant at Voisin Consulting Life Sciences in Paris, France before shifting to International Regulatory Affairs roles in Boston, USA. In Shire Pharmaceuticals, Helene was the Asia-Pacific Regional Regulatory Lead and Regulatory Head of Southeast Asia. In Takeda, Helene was the Global Regulatory Lead for plasma-derived therapies, then acted as the Regulatory Liaison for the Emerging Markets.
Currently, she is an active member of the Global Regulatory Policy Network (formerly APEC Rare Disease Network), APAC Digital health Data Consortium, APAC RA-EWG, EFPIA-ASEAN and Korea-Taiwan network.
Helene holds a Master of Sciences degree in Biotechnology and Management from the ESIEE-Management school in Paris.

Strong Regulatory Affairs professional with 13+ years of experience within the pharmaceutical industry in regulatory Affairs across 4 different dynamic regions Middle East including GCC & KSA & -Africa including South Africa.
Driver for results and a team player in any project part of it to enable different product launches and business expansion in fastest but in safer manner to help our patients across our countries for our innovative products; being energetic self-motivated person who spreads positive energy in any team she is part of.
Strong advocate and part of pharma working group industry with an objective of shaping the regulatory environment with an excellent knowledge of RA environment to be able support more patients towards innovative products to improve quality of life and reduce mortality.

BSc in Pharmacy from Jordan University, 1991.
MSc in drug analysis from Monastir University, Tunisia, 1998.
PhD in Pharmaceutical sciences from University of Lille II, France, 2005. PhD thesis was awarded with distinction, and it was nominated for “State Prize” at the Pharmaceutical Academy in Paris.
I have been working in the pharmaceutical industry for around 30 years. Joined Hikma Pharmaceuticals in 1991 and worked in different technical departments, with many years of hands-on experience in the formulation and process development, as well as analytical development of oral and injectable generic products. I held the position of Technical Director in Medicef (a newly established sister company for Hikma in Tunisia) for seven years, where I established all the technical departments: QA, QC, Product Pipeline, technical transfer, and Regulatory Affairs. I also headed the Research and Development – Injectables department in Amman for around 10 years and successfully developed and registered new generic products targeting global markets in USA, EU, and MENA.
Currently, I am heading the Regulatory Affairs activities in the MENA region, contributing to the development of the Regulatory strategy as well as setting the required implementation plans and programs that ensure effective and efficient function’s performance to best serve business needs across the region; while overseeing the Regulatory Affairs operations considering compliance with the internal and external policies and legislations, including submissions of new products in the pipeline and the maintenance of the existing portfolio in more than 14 countries in the MENA region, with local regulatory affairs teams in the majority of these countries. Work closely with health authorities and work on shaping the regulatory environment through liaising with the local agencies, local pharmaceutical organizations and associations and other stakeholders.

Other Activities in the Educational Field:
Jordan University of Science and Technology-Deanship of Scientific Research:
Member in the “Scientific Research Committee” during the scholar year 2019-2020.
Yarmouk University:
Member in the Faculty of Pharmacy board during the scholar year 2018 – 2019.
Jordan University of Science and Technology (JUST) & Yarmouk University:
Deliver lectures to 5 th year Pharmacy students on the application of certain concepts and technologies in the pharmaceutical industry, focusing on bridging the gap between theorical knowledge and practical application (started in 2017 till now).
Jordanian Association for Pharmacists: Received an appreciation and recognition award from the “Jordanian Association for Pharmacists” for the significant contribution to the development of pharmaceutical industry in Jordan (March 2019).

Regulatory Affairs Senior Manager who has joined Hikma Pharmaceuticals LLC since 2011, as a direct contact with the Jordan Food and Drug Administration, then expanded to the rest of Levant, North Africa and GCC with executing regulatory strategies, coordinating submissions, and maintaining product registrations covering the mentioned regions, along with the biotech segment in MENA since 2019.

A results driven professional with an interest in entrepreneurship and innovative technology, industrial engineer with a recent graduate degree in International Production Management from Hamburg University of Technology, having strong academic records and a profound operations and corporate management experience across healthcare and pharmaceuticals industries, mainly in emerging markets. Leading an interdisciplinary projects portfolio covering; organizational and business development, new product development, and technology transfer. Certified PMP®, professional in business analysis (PMI-PBA®), and associate consultant in SAP ERP applications.

A passionate and experienced Regulatory Affairs Professional with more than 14 years of three-dimensional experience at the level of pharmaceuticals regulations for registration of local manufactured &/or under license products, local generic products, and innovative imported products (Biological and Chemical) covering the scope of the MENA region (18 countries: GCC, Levant, Near East, Egypt, and North Africa). In addition to the regulatory experience, Sara built across the years, a deep diverse experience at multiple levels including but not limited to: Regional Pricing Regulations & Mechanisms, Localization Opportunities and Challenges, and Regulated Access Opportunities.
In August 2023, Sara was granted an expanded role to lead the PV unit in addition to the Regulatory department. Sara is currently holding the Regulatory and PV Manager position at Biologix with a team of 10 Regulatory and PV professionals located across several countries in the region including KSA, UAE, and Lebanon.
Honored to serve medical community and patients throughout this exciting Registration and PV journey, working closely with a team of passionate experts where we join hands to support pharmaceutical companies register their innovative products in the MENA, designing optimal registration strategies, advocating to patients’ safety, and contributing for a world of safe and effective medicines accessibility.
Scientific Background: Pharmacist (since 2009) & holds MBA in Management (since 2018) .
Sara is a pharmacist graduated from Beirut Arab University in 2009 and holds Master’s Degree in Business Administration (MBA in Management) from Sagesse University on July 2018.

PharmD
Pharmacologist
Past VP of Syndicate of Innovative Pharma in Tunisia
Master degree in Drug development, Monastir University, Tunisia
Master Degree in Health, Law and economics, Paris XI University, France

Dr. Amal has more than 15 years’ experience in the Pharmaceutical Industry,

Her career journey is diverse, and she had the pleasure to experience different roles in the pharmaceutical industry starting from Sales moving to Sales Force Effectiveness and then shifting to Regulatory, where she found my passion and kept progressing in her career development managing all the functions under Science scope on zone level (Regulatory, Medical, Quality & Pharmacovigilance) till reaching her current role as “AMET Science Hub Head in Sanofi Consumer Healthcare” responsible for(Regulatory – Medical) across Africa, Turkey & Middle East .

Dr. Hossam Abo Ouf, Country head of KSA & UAE for Consumer Healthcare business with 20 years of Consumer healthcare business experience in multiple companies (Nahdi, Pfizer, Boehringer Ingelheim & Sanofi) covering Saudi Arabia, Gulf, levant, Turkey & other middle east geographies.
Hossam is holding a bachelor’s in pharmacy with a career experience in commercial management, Marketing, shopper marketing and general management.
Since appointed as Country Head for KSA & UAE, Hossam is managing both perimeters out of Jeddah city focusing on unlocking Self-care opportunities and launch global brands to serve the rising consumer needs inspired by the country ambitious 2030 vision.

Since 2017 Michael supports the EXTEDO team as Business Consultant, focusing on drug regulation and registration. He is active in EXTEDO’s Regulatory Competence Center, where he monitors regulatory standards worldwide. His focus regions are Europe, EAEU, Asia, and the Middle East including GCC countries.
Michael is a professional regulatory and software trainer for EXTEDO’s customers globally. He manages customer projects, provides advanced regulatory customer support, and publishing services. He has more than six years of experience with regulatory and technical, tool-specific consulting on EXTEDO’s product portfolio in projects with industry and agency customers worldwide.

He leads a pioneering consulting, services, and solutions firm specializing in pharmaceutical product serialization. With a background in IT and supply chain management, Zeeshan established CosmoTrace in 2018 to address the critical need for comprehensive IT solutions in pharmaceutical serialization. Under his guidance, CosmoTrace has emerged as a frontrunner in the industry, providing tailored solutions and services to meet global serialization and traceability regulations. Zeeshan’s commitment to patient safety and industry excellence drives his vision of a future free from counterfeit medicines, where every product is traceable and secure. Connect with Zeeshan and explore CosmoTrace’s innovative solutions at www.cosmotrace.com

Fabrizio Maniglio is an industry thought leader and the Director of Industry and Business Development for Honeywell. He leverages vast subject matter expertise to drive innovation for the industry and within Honeywell, where he continuously monitors the evolution of the ever-changing healthcare and life-sciences sectors. He fosters contacts with other industry thought leaders and regulators to collaborate and influence the future of our industry.
He contributed five years as an Expert Solutions Engineer with Honeywell – Sparta Systems, deepening his understanding of quality life cycle management and the life science industries. He was a key differentiator in helping customers achieve their quality management goals.
Before Sparta Systems, he served nine years at a leading European-based Contract Manufacturing Organization (CMO) in the Pharma, Biotech, and Specialty ingredients industry. He served in numerous global quality-related roles, spanning Deviations Management, Head of Audit QA and Compliance, and most recently as QA Manager for Data Integrity and Computer Systems Validation in Switzerland, the UK, and China.
As a result, Fabrizio provides a blend of deep industry, QMS, and cutting-edge technical knowledge and is uniquely placed to advise customers and the industry on the future of quality.

Over the last 16 years of my career, I have developed strong working relationships with the various Ministries’ of Health (MOH) in the Middle East and thus consolidated my presence as a seasoned pharmaceutical regulatory affairs professional in the region.
I have completed my B. Pharm in 2002 from Dubai Pharmacy college and Master of Science in EU Regulatory affairs from KREMS , Vienna University and MBA from Preston University.
In 2013, I co-founded Professional Regulatory Affairs (PRA), a leading healthcare regulatory consultancy in the Middle East. To further uphold the ethics and compliance standards within the industry, I also persevered with Dubai Pharmacy College, industry experts and authorities to set up the GCC Regulatory Affairs (RA) Course, a first-of-its-kind certification, which educates graduates and professionals on the new career advancements and opportunities in this sector to become industry experts.
My true passion lies in helping authorities to find solutions and apply policies and regulations, which will lead to better health and safety within the regional communities. I have been instrumental in launching the GCC Regulatory Affairs Pharma Summit in 2015 and running it successfully for the last five years in Dubai. I also launched PHARMA REG AFRI summit , MEVAS and ACRAS summits in the region .
I am advisory board member with Dubai Pharmacy College and a member with the Women’s’ Business Council at the Dubai Chamber of Commerce.
I have been recently elected as a board member at Emirates Medical Association – Pharmacy chapter

She is a prime pharmacist, and the head of 1st registration committee in registration department/directorate technical affairs/ Iraqi MOH. She recently became the manager of pharmacy department in the same directorate-MOH.

Coordinator at the Direction Of Registration of the Pharmaceutical Products at the National Agency for Pharmaceutical Products (ANPP).

She is the Sub-Director of Drug Pricing at the National Agency for Pharmaceutical Products (ANPP).

She is the Sub-Director of Technical and Regulatory Control of Pharmaceutical Products at the National Agency for Pharmaceutical Products (ANPP).

Doctor Saida Foughalia Fridi, Sub-Director of Scientific and Documentary Evaluation of Medical Devices at the National Agency for Pharmaceutical Products (ANPP).

Dr. Rana holds a master’s degree in pharmaceutical quality assurance, with more than 16 years of experience in the field of Regulatory affairs, both the theoretical knowledge on legislations governing medical products & the understanding of the technicalities involved in regulatory submission.
Also serving as head of the clinical studies department for more than 5 years gave her experience in the field of clinical trials operations & GCP guidelines.
Also she was a member of the regulatory team who collaborated in the preparation & review of the “Guidance for Registration of Biosimilars in Jordan” that was published in May/2015, also she is a well-recognized speaker in the field of Biosimilar regulations & requirements, also she has fair knowledge in Intellectual property & public health issues related to pharmaceuticals.
She started her career in the private sector then moved to JFDA in 2008, since then she has held many positions including head of new drugs registration section, head of biological and vaccine registration section, head of Clinical Studies Department, administrative assistant to director general.
She chaired and was a member of many technical committees at JFDA and MOH.

Dr. Eman Hussien is the manager of Human Pharmaceuticals Regulatory Affair Administration, at the Egyptian Drug Authority (EDA), where responsible for the market authorization of new registration and re-registration of human pharmaceutical products.
She started her career as a Teaching Assistant at the faculty of pharmacy after graduating from 6 October University with a grade excellent with Honor in 2012, Then started a new career path as a Pharmacovigilance specialist at the Central Administration of Pharmaceutical Affairs, in 2020 with establishment of EDA Started a new career as Senior Regulatory specialist until November 2021 where promoted to the Manager of Evaluation unit of registration file for local human pharmaceuticals then promoted to the current title in EDA as the Manager of Human Pharmaceutical regulatory affairs Administration at EDA in June 2023.
Over the span of more than 11 years, Eman has gained extensive experience in various areas of the life sciences sector, with a focus on Regulatory Affairs, Pharmacovigilance although participated in several strategic projects, such as the WHO program for Pre-Qualification of Egyptian Drug Authority, the Establishment of the Egyptian drug database (DDB), EDA Chairman decree 450/2023 regarding the Registration process of pharmaceutical products, EDA Chairman decree 150/2022 regarding Re-Registration process of pharmaceutical products.
Her achievements include completing the Executive Management Diploma (EMD) at AUC 2018, and the Master of Business Administration at AAST in Cairo (2023-2024).

Mr. Babiker has more than 25 years of experience in different fields of pharmacy practice including hospital pharmacy, community pharmacy, clinical pharmacy, drug information, patient safety, quality and risk management. He has presented many papers in international scientific conferences and published an original research article in reputable Journal.
Mr. Babiker is a pharmacist with initially a degree from Sudan, which he substantiated by doing additional internationally, recognized examinations. He has research experience through a Master program at Queens University Belfast in the United Kingdom. His research interests are in the areas of patient safety and pharmacy practice.
He has worked as drug information pharmacist at Hamad Medical Corporation, the principal health institute in Qatar, which contributed to his clinical knowledge and skills. Through his work for the Ministry of Public Health, especially the Community Pharmacies Steering Group for the National Health Strategy Project 1.6 Community Pharmacies Strategy and as vaccine registration supervisor, he also has experience with the development of policies.
In addition, Mr. Babiker is interested in sport activities; he was volunteering with Qatar Anti-doping Commission as a Doping Control Officer (DCO) since 2005. He participated in many and different sports activities in Qatar such as DCO, education & outreach program as well as DCO Venue Manager.
Moreover, Mr. Babiker participated actively in preparing an outreach and education team during IAAF in 2019, in which he had been awarded appreciation letter from the director of WADA. He has been awarded recently grateful recognition for the excellent service for the FIFA World Cup Qatar 2022.

Muna Al Saidi stands as a dedicated professional at the forefront of healthcare administration, currently holding the esteemed position of Section Head in the Registration Section of Human Medicine at the Ministry of Health, Oman. With a passion for ensuring the seamless operation of medical registration processes, Muna Al Saidi has become a respected figure in the healthcare sector of Oman.
Known for her strategic vision and meticulous attention to detail, Muna Al Saidi has played a pivotal role in streamlining registration procedures within the Ministry of Health. Her commitment to excellence has not only earned her the trust of her colleagues but has also contributed significantly to the overall efficiency of the healthcare system in Oman.
As a seasoned leader, Muna Al Saidi brings a wealth of experience to her role, coupled with a deep understanding of the complexities involved in managing the registration of human medicine. Her dedication to advancing healthcare services reflects a commitment to enhancing the well-being of the Omani population.

Aisha has 5 years’ experience with NHRA in the Pharmacy and Pharmaceutical Product regulation Department as a Regulatory affairs specialist, responsible for re-registration of applications and review of the submitted Registration, variations, and renewal applications.
She also participated in the conferences held by NHRA, and she was part of the Grievances committee filed by Pharmacy Practitioners and Pharmacy centers.

She has graduated from the University of Jordan faculty of pharmacy in 2017, following that in 2018 she joined NHRA as a team leader of the Medicine variation as a primary responsibility.
Through her journey at NHRA, she gained extensive experience and knowledge in e CTD submission, evaluation of the medicine new registration files and safety notification.
Additionally, she is responsible for identifying any safety concerns related to medicine and ensuring that those concerns are addressed to the health care professionals where appropriate.
In June 2023, Shima participated in the 3. NHRA regulatory conference as a speaker in the main conference hall.

H.E. started his career at the Ministry of Health in 1985 while still pursuing his education. He graduated from Aberdeen University in Scotland with a Ph.D. in blood transfusion medicine in 2003. He revolutionized the blood transfusion practices in the UAE with the establishment of 3 world-class centers for blood donation and the development of all relevant policies.
He was appointed as assistant undersecretary since 2006 and he successfully handled various responsibilities with the Ministry of Health.
Currently, as the Ass. undersecretary for Health Policies, H.E. is responsible for the Drug management, Control, Audit and Inspection, Licensing and Accreditation, Standards and Guidelines along with the Organ Donation and Transplantation Office.
His excellency has written numerous books and scientific publications in the field of blood medicine and received many awards from local and international organizations for his contribution to science and his commitment to humanitarian causes.

Currently, he is the Regulatory Affairs Lead in Acino, based in Cairo Egypt, managing Gulf Eastern Mediterranean (GEM) Region including 6 Countries (UAE, Kuwait, Bahrain, Oman, Qatar, Jordan.
Dr. Khaled hs more than 12 years’ experience in Regulatory Affairs in different region; GCC, Middle East, & North.
He started his career in 2002 in Manufacturing Quality Assurance & Validation.
Then he has shifted to Regulatory Affairs since 2006 & he has been working among many local & multinational companies such as Novartis & Pfizer until joining Acino in 2019.

Dr. Lamis Youssef is the Senior Regulatory Affairs Manager, Gulf cluster in Pfizer. She has over 11 years of experience in Regulatory Affairs (RA) across the pharmaceutical industry.
She joined Pfizer in 2016 as Regulatory affairs manager handling Africa middle east region for a diverse portfolio & was responsible for the Regulatory management of Hospira acquisition within Africa middle east region. In her current role, Dr. Lamis is handling multiple therapeutics areas for innovative portfolio.
She is also an active member within the Gulf trade association and is currently leading the Trak & Trace and e-labelling taskforce within Regulatory Affairs working group.
Before joining Pfizer, Lamis worked as regulatory affairs for J&J medical devices and  Julphar, prior joining regulatory she had different roles working as production and quality assurance expert in different pharmaceutical companies in Egypt including Sigmatec and GSK.
Dr. Lamis graduated from faculty of Pharmacy 6^th October university, she has a six sigma green belt certificate and she is currently pursuing her MBA.

Extensive knowledge and experience in Pharma industry and Health care sector, Regulatory affairs, Regulatory policy and governmental affairs for over than 22 years.
Dina  Joined MSD in 2011, leading Egypt operation and extended responsibilities in 2015 for Egypt, Libya and KSA.
Then moving to Gulf, now she is heading  Middle East Region-Levant cluster, Egypt cluster, Gulf and KSA at MSD.
Before Joining industry, Dina has been working as a Health authority regulator for Drug polices and Planning center for Ministry of Health in Egypt for 10 years, head of  departments (Pharmaceutical Products-Animal Health and Dentistry medical devices).  Dina is an active member for trade associations, Pharmag, Regulatory group within Pharma Middle East and Africa and Middle East Regulatory network within EFPIA.
Education: Bachelor of Pharmacy – Faculty of Pharmacy – Cairo university, MBA- Maastricht school University-The Netherlands.

Inas is a holder of Pharmacy diploma, and Master in EU and International Regulations and Healthcare Laws from Paris V University.
Inas has 20 years expertise in the European and Emergent markets regulations; she worked for various MNCs, and currently she is heading the Regulatory and Policy departments for MEA region in Novartis.

Her focus and interest are the Healthcare reforms and legislations, policy shaping with main objective to accelerate patient access to innovative medicines.
Inas chaired EFPIA and PhRMA association groups for 6 consecutive years, and actively participating as speaker in regional and international conferences.

Dr. Fahad worked with Saudi FDA and multiple multinational pharma companies during his career.

Strongly reliable and focused Pharmacist with great depth and breadth of experience in the pharmaceutical industry as regulatory affairs specialist. Superb multitasker able to handle multiple projects efficiently and accurately. Effective independent worker as well as excellent coordinator with other members of the team.

Ahmad is a UAE legal consultant overviewing the MENA-region wide Innovation & Patents practice, based out of Dubai since 2011. Ahmad is a Canadian attorney and computer/electrical engineer by background with over 12 years of higher education studies in law, engineering, and business management. He also comes with over 17 years of international and MENA related experience in intellectual property, patents, technology transfer, innovation advisory, entrepreneurship, and commercial law. Before joining Al Tamimi & Company, he worked for reputable Canadian and international law firms.
With his three-helix qualifications – legal, engineering and innovation management, Ahmad brings to the benefit of client’s rich three-dimensional expertise combining legal, technical, and business.  He is particularly skilled in strategizing and is uniquely positioned for combining the various pieces of the puzzle together particularly in complex projects with sophisticated legal, technical, and business components such as public policy gap analysis and studies.
Ahmad is the designer, founder and lead of Al Tamimi & Company’s cutting-edge Innovation, Patents & Industrial Property (3IP) practice and pioneering 3IP service model covering unique legal, business and technical consultancy in the field of innovation, patents and industrial property rights throughout the entire innovation life cycle.  Ahmad leads a seasoned diverse team comprising IP lawyers, tech transfer lawyers, patent attorneys, technical consultants and business consultants providing specialized IP legal, technical, and business consultancy services to clients with a focus on technology, R&D and innovation.
With a focus on innovation, entrepreneurship, and tech driven industries under both the engineering and life sciences sectors, Ahmad’s practice covers a wide spectrum of services from IP/Patent prosecution & procurement, IP/Patent portfolio management, IP/Patent litigation, IP transactional & tech transfer, IP strategies, auditing, due diligence & opinions. Ahmad also advises governmental entities, research institutions and consultancy firms in high-level innovation strategies, legislative, regulatory, innovation policies, processes, innovation fostering, and setting legal frameworks for the implementation and deployment of innovation projects and organizations.
Ahmad is one of the most experienced patent lawyers and innovation councils in the Middle East and is widely recognized for his strategic and visionary thinking and leadership. Ahmad sits on various committees and advisory panels including, the Global Advisory Panel of the UAEU Science & Innovation Park, the Global Entrepreneurship Monitoring (GEM) UAE Steering Committee, the Innovation Advisory Board of the Dubai Healthcare Authority, and the Herriot Watt Advisory Board. He regularly mentors start-ups throughout their business cycles, from the incubation stage to advanced maturity stages.
Ahmad is regularly invited to speak at innovation events and has been interviewed on various television channels, newspapers, and magazines in relation to innovations, entrepreneurship and intellectual property, including Dubai TV, Emarat TV, Fujairah TV, the National, International Bar Association, Thomson Reuters and has an extensive library of publications.

Nadia is an accomplished public affairs and regulatory consultant offering a unique perspective in pharma and healthcare having extensively worked for more than 30 years in both the industry and at /with the regulatory government authorities.
Nadia is recognized in her field as a Regulator at MOH-UAE heading the Registration & Pricing and for her contribution in shaping the GCC-UAE regulatory frameworks and guidelines for pharma, medical devices, and clinical research in the GCC.
Nadia later worked for Pfizer Gulf & Levant (2011-2017) and AstraZeneca-ME (2017-2019), leading the functions for Regulatory and Governmental Affairs.
Currently she is a consultant for multinational Pharma (Jan 2019-to date) such as NewBridge pharmaceuticals, Takeda, Abbott, Alnylam, Inibsa, Eurofarma, and others including many local and foriegn manufacturers.
Nadia’s consistent purpose is to raise awareness among authorities and companies on the importance of strengthening the regulatory system for the advancement of the countries and its ECO system.
Nadia has a Bachelor’s degree in Pharmacy from Jordan University (88), a Masters’ degree in Healthcare Management from Zayed University (2008) and a Master’s degree in Public Health (MPH) from John Hopkins University, School of Public Health in Baltimore, USA, (2011), where she has also completed her advanced studies for the Dr PH program (2015).

Dr Kurdi earned her PhD Degree in Biopharmaceutical Science in 2015 from University of Greenwich in UK.
Dr Kurdi is currently working as Regulatory Affairs & Public Policy Senior Manager for EMEA Region at USP. USP is a non-Profit non-Governmental Organization with mission of assuring Quality of Medicines. Main responsibilities are to engage with USP Stakeholders, mainly National Regulatory Authorities, National Control Laboratories, International Organization like WHO, Pharmaceutical Association, Drug Policy Makers with topics and initiatives related to Heath and Quality.
Dr Kurdi has over 30 years of experience in pharmaceutical industry in Quality Control, Quality Assurance, Research and Development, Regulatory Affairs, Commercial and Business Development including Technology Transfer (TT) as well licensing activities. Dr Kurdi held executive and management position during her work with Pharmaceutical Industry.
Additionally, Dr Kurdi served as a member with more than committee nationally and international; with JFDA on re-registration of generic products, Control of Pharmaceutical Products, Control of Active Pharmaceutical Ingredient used in Pharmaceutical Product, Value Added Medicine and Site Accreditation Committee.
With United State Pharmacopeia as an expert in the advisory panels of General Chapter (1197) and with International Generic and Biosimilar Medicine Association (IGBA) representing JAPM in Biosimilar Committee.
Dr Kurdi has many research papers published in Scientific Journals and she is frequent speaker in Pharmaceutical Conferences.

Amani Mansour is currently the Head of Regulatory Affairs, Gulf cluster in Pfizer. She has over 13 years of experience in Regulatory Affairs (RA) across the pharmaceutical industry and governmental sector.

She joined Pfizer in 2011 and handled different roles within the regulatory team/ in Pfizer starting with above country role supporting Africa middle east region moving to an in-country role where she was leading the regulatory team within gulf and levant and Currently Amani is heading the regulatory affairs organization within Pfizer gulf.
She joined Pfizer in 2011 and handled different roles within the regulatory team/ in Pfizer starting with above country role supporting Africa middle east region moving to an in-country role where she was leading the regulatory team within gulf and levant and Currently Amani is heading the regulatory affairs organization within Pfizer gulf.

Dr. Fouad H. Darras Graduated with a PhD in medicinal chemistry from Regensburg University in Germany (2014) and a master’s degree in intellectual property rights (LL.M) from the University of Turin- Department of Law in Italy (2016); the program was jointly organized by the International Training Center of the International Labor Organization (ITCILO) and The World Intellectual Property Organization (WIPO).

Ms. Farida Joined the generics pharmaceutical industry in 2010 as the RA officer in the Jordanian Pharmaceutical Manufacturing Company (JPM). Since then, she worked in several positions in RA and licensing field during the past 12 years. In 2013, Farida was introduced to the Intellectual Property (IP) field. Until April 2022, she was the Intellectual Property Manager for Axantia group, responsible for developing and managing intellectual property strategies and activities within the department and with multiple businesses and development teams.
Since 2013, Farida has worked to build her knowledge, capabilities, and experience in IP by formal studies, professional training and working in this field as the generic pharmaceutical industry needs to take Intellectual Property into consideration.
She earned a Bachelor degree in Pharmacy from Jordan university of Science and Technology, an MBA in Quality management from the German Jordanian University -TAGCB, and LL.M. in Intellectual property law from Turin University jointly with WIPO.

Shekhar Kapoor is a Senior Strategy Consultant with the India office of Siemens Advanta Consulting. During his tenure with Siemens he has undertaken digitalization projects such as Factory Digitalization across Siemens’ factories in India.
In UAE, he has conducted Industry 4.0 readiness assessments using MoIAT’s Industrial Technology Transformation Index (ITTI), for factories spanning across sectors such as pharmaceuticals, chemicals, ceramics, plastics, cement and metals.
Prior to joining Siemens, Shekhar was a tenured consultant with the India office of Boston Consulting Group (BCG) focusing on their healthcare practice wherein he has advised Indian and American pharmaceutical giants on topics ranging from throughput improvement, site shutdown and building clinical decision support system (CDSS) for doctors.

Varun offers Management Lead for Forge Track & Trace in Honeywell. Prior to Honeywell, he has worked with GE for their digital solution business and Nokia Siemens Networks for the communication technology business. In addition, he is an Alumni of the prestigious “Commercial Leadership Program” from GE. As for his education, he has a Bachelor of Electronics for NIT Surat, India and MBA in Marketing from IMT Ghaziabad, India. He has 11 years of Diverse experience in Industrial software solutions in Logistics, Connected Industrial and Transportation domain.

Santosh Balbhadra Trivedi has a Bachelor of Engineering (Chemical) degree from G H Patel College of Engineering and Technology, Vallabh Vidyanagar, Gujarat, India, where he studied from 1998 to 2002. He has almost 20 years of overall experience and has worked in the Pharma & Life Sciences industry vertical for over 12 years in various roles from a Developer to Business Analyst, Product Owner, Serialization and Track & Trace expert, etc.
His current role since Feb-2022 is with Honeywell as the Senior Product Manager – Track & Trace facilitating governments/customers implementing Serialization and Track & Trace solutions to adhere to/implement the legal regulation requirements and/or to implement the value added solutions to improvise the supply chain visibility and integrity.

A collaborative, strategic professional with a highly result oriented and problem-solving mind.  Almost 17 years of regulatory affairs practice and efficient training courses gave him a solid and enriched knowledge in different regulatory aspects in terms of registration of medicinal products; GSL products and medical devices, Marketing authorization functions, post approval changes and renewal process. His core strengths and competencies are building new Regulatory departments and leading cross functional team as well as developing creative regulatory solutions that reflect on achieving the company organizational commercial targets and business objectives successfully.

Ebla Khadra has over 12 years’ experience within the pharmaceutical industry in Regulatory Affairs across different regions GCC, Lebanon, and several countries  in the continent of Africa. Ebla is currently the Regulatory Affairs Specialist for Middle East region in Takeda pharmaceuticals  a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, PDT Immunology , Gastroenterology and in some markets Neuroscience and Vaccines. .
Before joining Takeda Pharmaceuticals , Ebla was Regulatory Affairs consultant at Shire pharmaceuticals for Middle East appointed by PRA before Takeda acquisition of Shire.

• Appointed as serialization champion since 2020.
• Strong Regulatory Business Partner driving for results with very high level of accountability supporting with successful launches to help our patients across our countries access to innovative products.
• She has excellent knowledge of pharma environment, regulations in Middle East and goes the extra mile embracing business dialogue

Scientific Background: Pharmacist (since 2009) & holds MBA in Management (since 2018).
A passionate and experienced Regulatory Affairs Professional with more than 13 years of three-dimensional experience at the level of pharmaceuticals regulations for registration of local manufactured &/or under license products, local generic products, and innovative imported products (Biological and Chemical) covering the scope of the MENA region (18 countries: GCC, Levant, Near East, Egypt, and North Africa). In addition to the regulatory experience, Sara built across the years, a deep diverse experience at multiple levels including but not limited to: Regional Pricing Regulations & Mechanisms, Localization Opportunities and Challenges, and Regulated Access Opportunities.
Sara currently is the Regulatory Manager and heads the regulatory department at Biologix with a team of 10 experienced regulatory professionals located across several countries in the region including KSA, Algeria, Egypt, UAE, and Lebanon. She works with her team to support pharmaceutical innovative companies by offering early access and accelerated registration strategies (where applicable as per the regulations) to bring differentiated brand products to the region, helping medical communities reach the innovative treatment they pursue for their patients.
Sara is a pharmacist graduated from Beirut Arab University in 2009 and holds Masters Degree in Business Administration (MBA in Management) from Sagesse University on July 2018.

Zayd Alathari is a Partner and Head of Intellectual Property (IP) based in Norton Rose Fulbright’s (NRF) Riyadh office. He focuses on all aspects of IP law, including supporting and developing IP strategy, capacity building and infrastructure, including policies, procedures, guidelines, workflows and best practices; managing and advising on patent, trademark, trade secret, copyright portfolios and matters; and drafting and negotiating a wide variety of IP and technology transactions and deals for IP commercialisation.
Before joining NRF, Alathari worked at Saudi Basic Industries Corporation (SABIC), where he helped develop and lead the company’s IP initiatives as its Senior Manager & IP Counsel in the Middle East and Africa. In over eight years at SABIC, Alathari led a team that supported SABIC’s Middle East and Africa manufacturing teams and the company’s global technology & innovation teams for the chemical, agri-nutrients and metal business in the US, Europe, Middle East, China and India.
Before his in-house career in Saudi Arabia, Alathari practiced at a major US law firm in Washington, DC.  He holds a Juris Doctor in Law from the American University, DC, a Master of Science in Biotechnology from the John’s Hopkins University, MD, and a Bachelor of Arts in Biology and Religion Minor from the George Washington University, US.

Alathari is also a member and key advisor of the Research & Innovation Committee of the Gulf Petrochemical and Chemical Association (GPCA) and the Legal Liaison for the Arts, Culture & Entertainment (ACE) Committee of the American Chamber of Saudi Arabia (AmChamKSA).

Mr. Baha is a seasoned Technology Executive with 25+ years of experience in defining, managing, and delivering high-profile technology transformation programs. He has a strong strategic business & technology insight into several verticals including Public Sector, Healthcare, and Smart Mobility.
Mr. Baha is the Program Director for the nation-wide Tatmeen Program from EVOTEQ, the Technology Implementer and Technology Operator of the nation-wide Tatmeen Platform.

Over a span of 29 years in the business world, David co-founded 6 innovative enterprise level software companies and served in a variety of executive leadership roles in highly competitive complex technology markets including three separate stints as CEO (totaling 19 years), Chief Product Development Officer, Chief Marketing Officer, and EVP of Strategic Development.
He also has extensive experience in risk management, corporate governance and serving on and reporting to diverse boards of directors and shareholder groups.
Through his career as CEO David has initiated and led strategic partnerships and significant co-product development initiatives in security and healthcare sectors with collaboration partnerships at the highest executive levels of Microsoft, AT&T and Raytheon, through multiple versions releases and millions of lines of code.
In 2016 David completed the initial R&D and co-founded AVC Global Inc, the parent company of Medical Value Chain that has emerged as a leading-edge supply chain platform with track and trace technology.
David developed the initial technology solution vision and architecture and built a strong team to develop the product and integrations, called SmartHub, SmartPass and Value Chain Finance.
David lived in Bahrain from 2019 through mid 2022 to help stand up the MVC track and trace solution platform for the NHRA.
David also utilized his vision and win/win solution sales skills to win over 375 contracts including high-profile, and early adaptor customers, in government agencies and public companies, and with officials at the highest levels of government in the USA, Asia, Eastern Europe, India, Africa, and the GCC.

Hasan is a Product Identification and Serialization specialist with expertise in supporting Traceability, Tracking, Brand Protection, Claims Verification, Customer Loyalty, and Secure Supply Chain management. He is a Subject Matter Expert in Pharmaceutical Serialization for Patient Safety and Regulatory Compliance across various markets, including DSCSA, EUFMD, Russia/MDLP. Hasan has achieved regulatory compliance for numerous Brand Owners and CMOs operating in multiple markets, and integrated over 50 contract firms, brand owners, and distributors utilizing various equipment offerings. He has an Expert Level understanding of GS1 standards and the vocabulary and choreography for supply chain events at various levels.

As the Senior Manager of Regulatory Affairs and Pharmacovigilance at Insights Research Organization and Solutions (IROS), Dr Marie leads operations associated with the conduct of clinical trials in accordance with all applicable regulations & study-specific requirements and ensures that research sites are prepared and have the necessary tools needed to start the trial. In addition, her department manages the safety profile of new drugs in clinical trials, oversees case-processing activities through all phases of development, and perform regulatory reporting and medical monitoring tasks.
Dr Marie has over 15 years of experience, the last 8 of which have been in Regulatory Affairs including the regulation of clinical research, continuous education, professional licensing, and auditing of health advertisements.
Prior to joining IROS, she headed the Research and Education Regulation Department at Dubai Healthcare City Authority where she oversaw the regulation of human subject research including non-interventional studies and complex clinical trials. She also sat on the IRB of Mohammed Bin Rashid University of Medicine and Health Sciences as the Regulatory Representative.
Dr Marie graduated with a degree of Doctor of Dental Surgery in 2008 and also holds a Master’s Degree in Healthcare Management and a Postgraduate Diploma in Clinical Leadership and Innovation from the Royal College of Surgeons in Ireland.

A pharmacist by graduation, with experience in healthcare policy, market access and health systems. I have 18 years of national and international experiences, working in the government sector, pharmaceutical sector and in various projects with international organizations. This was further enabled by earning a master’s in business administration in healthcare management form Loyola university, Chicago USA.
Currently as the government affairs director for the gulf region, my focus is to ensure holistic partnership with governments towards progressive policymaking. In my previous global roles, I have worked to ensure that clinical development plans address global unmet healthcare needs and create access for innovative pharmaceutical products along the clinical development journey.

Konstantin has more than 15 years’ experience in IT products and implementation of complex B2B solutions for large and medium-sized companies. Five years ago, he set up Utrace, with the aspiration of making the complex and expensive process of compliance smooth and efficient by providing scalable, user-friendly and cost-effective solutions with high levels of automation. Now, five years later, Konstantin is proud to say Utrace has helped over 50 companies in the pharma and FMCG industries successfully comply with a host of complex requirements.

«What I’m really passionate about maximizing business value for companies investing in compliance processes. All too often I’ve seen situations where companies looking to fulfill such requirements go well over budget as a result of choosing inefficient and inflexible software. Nothing gives me more pleasure than to come in and help these companies out of such a mire, and, needless to say, help other companies avoid ever getting into such a situation in the first place».

Hasan is a Product Identification and Serialization specialist with expertise in supporting Traceability, Tracking, Brand Protection, Claims Verification, Customer Loyalty, and Secure Supply Chain management. He is a Subject Matter Expert in Pharmaceutical Serialization for Patient Safety and Regulatory Compliance across various markets, including DSCSA, EUFMD, Russia/MDLP. Hasan has achieved regulatory compliance for numerous Brand Owners and CMOs operating in multiple markets, and integrated over 50 contract firms, brand owners, and distributors utilizing various equipment offerings. He has an Expert Level understanding of GS1 standards and the vocabulary and choreography for supply chain events at various levels.

Alf Goebel has been the CEO of advanco since 2019. He has overseen a significant period of expansion in advanco’s evolution, firmly establishing it as one of the globe’s leading providers of levels 2 to 5 item level serialization for the pharmaceutical sector.
Alf is a senior enterprise software sales, marketing & product executive, with over 25 years‘ enterprise software industry experience. He has strong operational experience, specializing in high growth businesses in Europe and the US. He has extensive experience with Global Partnerships in the SAP eco system. H also was a partner at Lupo Ventures and has held senior executive positions at several leading technology companies, including Snow Software, MSC Software and Software AG.
An internationally-recognized expert on regulated track and trace, Alf is an established industry commentator and speaks at pharmaceutical and serialization events across the world. He is also a board member of OPEN-SCS, the industry body responsible for promoting common standards across the pharmaceutical serialization sector.
Alf is resident in Silicon Valley and divides his time between Silicon Valley and Europe.

Bachelor’s degree in pharmacy/University of Jordan.
Regulatory affairs Global Certificate (RAC)USA
Hikma Pharmaceuticals (12 years)

JFDA (20 Years)
Head of registration department at Jordanian food and drug administration.

Speaker in many regulatory conferences.
Middle east CTD trainer /AUPAM
Head of Scientific committee /AUPAM organize and prepare 19 AUPAM conferences 2001-2019
Member in local and international organizations

Drug regulatory affairs Consultant in the area of clinical trials, Bioequivalence studies, Biosimilars, and cGMP with over 23 years of working experience in the academic, research, pharmaceutical industry & Drug regulatory affairs fields. A demonstrated history of working in the pharmaceuticals industry in Europe & GCC region. a Pharmacy study & a Ph.D. in Pharmacy focused on Pharmaceutical Industry from Christian Albrecht University Kiel, CAU Zu Kiel, Germany.
Outstanding Teaching Experiences in the following science fields: Clinical Pharmacy, Pharmaceuticals, Medicinal Chemistry, drug discovery, and Pharmaceutical Biotechnology.
A strong track record of achievements in my current position as a Drug Affair Consultant. My day-to-day tasks include, among others:
– Evaluation of more than 1100 GCC & Local clinical, Bioequivalence & Biowaiver (M5) studies for NDA & ANDA drug products.
– Evaluation of biotechnology & biosimilar products, including Covid-19 Vaccines, Monoclonal AB & Antiviral drugs.
– Evaluation of all SUPAC Variations types.
– Updating Local & GCC Guidelines as a member of the cGMP & Bioequivalence committees.
– Staff Training in the field of cGMP, GLP, Bioanalytical & clinical, and Bioequivalence studies.
– Updating presentations regarding the international pharma Industry Guidelines.
– Staff Training in the field of cGMP, GLP, Bioanalytical & clinical, and Bioequivalence studies.
– Updating presentations regarding the international pharma Industry Guidelines.
– Updating presentations regarding Covid-19 vaccines & treatment possibilities during the Covid-19 Pandemic time.

Dr. Rania Rawabdeh holds a bachelor’s degree of pharmacy from Petra University.
She has been a Pharmacy manager for more than 20 years and worked at Jordan Ministry of Health in Clinical Pharmacy Directorate.
She joined JFDA in 2019 registration department as a regulatory affairs specialist. In addition, she is the head of Re-registration of Originator Drugs committee and a member in committee to review the receipt of files submitted for registration.

Ahmed Al Bastaki is Chief Commercial Officer (CCO) at Rafed. A revered leader in the field of supply chain management, Ahmed has developed a wealth of knowledge and experience working on ambitious projects in the field of healthcare and project management.
With 30 years of experience, Ahmed has been responsible for the delivery of many projects locally within the United Arab Emirates and internationally for both the government and private sectors. His current role in Rafed requires expert knowledge in leading client engagements, developing trusted client relationships, creating high-impact strategic objectives, and maintaining long-term profitability.
His prior experience working with SEHA provided him with considerable knowledge and ability in healthcare management, supply chain management, contracts management, planning, and monitoring projects, performing due diligence, setting strategies, and operational optimization.
His academic record provides the foundation for Ahmad’s professional development. Ahmad currently holds a Bachelor of Business Administration (International Business) and is completing a postgraduate MBA (General Business Administration).

An enthusiastic, adaptive, and fast-learning pharmacist with ten years of experience. She had a broad and acute interest in applying analytical and research skills in herbal medicines including traditional complementary medicines.
Dr. Amani is dedicated in further studies in therapeutic role of medical treatments derived from natural plant materials. She is keen to improve current guidelines by formulating standardized regulations in order to ensure the quality, safety and efficacy of herbal and health products.

Dr Mariam Al-Jalahma was appointed by His majesty the King of Bahrain, in 2015 as the Chief Executive Officer of the National Health Regularity Authority in the Kingdom of Bahrain. She< is as a member of the supreme council of health in Bahrain, and is appointed by the prime minister as a member in Academic accreditation Committee of the supreme council for Higher education in 2016. Previous positions:
She was holding the position of Assistant Undersecretary for Primary Care and Public Health until 2015, and was a member of the Executive Board of The Health Ministers’ Council for GCC States until 2016.
A member of the Sura Council in 2000, and a member of the National Institute for Human rights. Dr. Al-Jalahma worked as an advisor for the world health organization in the fields of Adolescents and Non communicable diseases (NCDs).
Qualifications: Arab Board certificate in Family & Community Medicine in 1990
• Higher studies diploma in medical education from Dundee University in Scotland in 1994
– Diploma in Health Care Management from Royal college of surgeon in Ireland in 2000 Honorees & medals.
– In December 2011 she was awarded an honouree medal of efficiency by his majesty the king
of Bahrain.
– In 1990 Awarded by the prime minister awards for leaders of Moharraq.
– In 2009 she was awarded by Her Highness Shaikha Sabika Bent Ebrahim Al-Khalifa the
– Princess of Bahrain and Chairperson of Woman Supreme council the award of National
– Woman day Celebration, the award is presented to women leaders in health.
– In June 2011 she is awarded by the regional office for eastern Mediterranean of the WHO the
– Anti-tobacco award of the region.
– Global award for health pioneers from UAE
– GCC leaders Award 2019

Prior to joining the DOH, Dr. Khuloud served as the Manager of Pharmacy at Tawam hospital. She is a licensed clinical pharmacist with an interest in the infectious diseases area. Her academic qualifications include a Bachelor of Pharmacy from University of Jordan in Amman, Jordan (2006).
In 2011, she pursued her Doctor of Pharmacy (PharmD) degree from Purdue University, IN, USA. Additionally, she completed her master’s in healthcare management in 2021 from RCSI.
Dr. Khuloud is an active member of the American Society of Health-System Pharmacists (ASHP), the American College of Clinical Pharmacy (ACCP), and the Society of Infectious Diseases Pharmacists (SIDP).

She has a Masters in Pharmaceutical Technology from Ajman University of Science & Technology, bachelor’s in pharmacy from Dubai Pharmacy Collage, 15 years’ experience in the retail pharmacy, 10 years’ experience in Ministry of Health and prevention in the drug department import and export section. Team leader responsible for the implementation of ISO Continuity of business and ISO Risk Assignment & representative in the E-Transformation project in the drug department.
She has participated in Dubai international Pharmaceuticals & technologies Conference & Exhibition- DUPHAT 2016 and awarded the 11th best pharmacy student oral presentation award in 2016.

Dr. Rawya is a clinical pharmacist with broad Medical and Pharmaceutical knowledge, experience in various aspects of the Pharmaceutical Industry especially Medical Affairs, Regulatory Affairs and Pharmacovigilance, as well as knowledge and experience in the research field. She has a M.Sc. Clinical Pharmacy (with Distinction) – Queen’s University, UK.
Dr. Rawya began her career at Hikma Pharmaceuticals, Jordan since 1998 till 1999, and she is currently the Regulatory Affairs & Medical Affairs Director at Gulf Pharmaceutical Industries (Julphar), Ras Al Khaimah, United Arab Emirates since 2020 – to the present date.
In her role in Regulatory affairs, she displays and actions leadership in all aspects of Regulatory Affairs for company product portfolio of generics and novel products, including product development and submissions.
She is also an expert in defining the strategic regulatory direction for pipeline development and global launch excellence for a significant dedicated R&D budget. In addition, Dr. Rawya is knowledgeable of partnering with R&D and Global Strategic Marketing leaders as well another functional leader to develop and implement strategy for pipeline development and global launch excellence.

Dr. Yousra is a Regulatory Affairs and Commercial & Distribution Quality Assurance Director, Strategic Project Lead with over 18 years of diversified experience from various leadership positions in Regulatory Affairs , Quality Assurance within Health Authority as well as multinational organizations at both regional and local levels.
Dr. Yousra is currently leading Abbott-Gulf, Levant & Emerging Markets Regulatory Affairs, Quality Assurance and Strategic Projects. In her role in Abbott Established Pharmaceutical Division; Yousra is responsible for setting Regulatory Strategies for New Product Introduction, Geo-expansion, Licensing & Acquisition, Localization, Life cycle management, enhancement of promotional model, as well as Regulatory risk mitigation and regulatory compliance.
Dr. Yousra has set effective regulatory strategies of external engagement including Health authorities, local distributors, trade associations and Third-Party Manufacturers. This is in addition to her Quality Assurance responsibilities of establishing and embedding Quality Management System within GEM & Levant.
On top of that, she set the base for strategic projects within the Gulf & Emerging Markets and lead the execution of a variety of initiatives that support patient centricity.
Dr. Yousra is holding a bachelor of pharmaceutical sciences from Cairo University and RAPS-DPC certification/USA-UAE and She has also completed the “New Leadership Program (NLP)”, by Harvard Business School and is currently enrolled in “Professional Diploma in Business Planning and Strategy”, by Rochester Institute of Technology, USA.

Ingenious Quality Leader with over 23 years of profound GxP experience in sterile/nonsterile pharmaceutical and medical device within the context of Technical Ops, Manufacturing, CMO, Distribution and Commercial operations including over 12 years in a leadership position in multinational business culture. His experience spans across North America, EMEA and China.
He had a track record of leveraging multidisciplinary teamwork to establish and sustain a fit for purpose risk based QMS in accordance with USFDA, EU, Health Canada, and GCC regulations for sites globally. He was keen on fostering a culture of Data Integrity compliance and achieving corporate compliance governance which resulted in outstanding regulators inspection outcomes.

At a Global role, Mr. Mazen played a pivotal role in driving various business initiatives such as Pharma 4.0 and governance compliance programs, leveraging his strengths in risk-based critical thinking, problem-solving, and proactive process control.
His leadership has led to quality transformations and seamless integration of new acquisitions worldwide, showcasing his precision and efficiency in executing strategic initiatives. Further, he deployed operational excellence utilizing lean manufacturing principles and kaizen tools, which optimized processes, reduced product defects, and positively impacted the bottom line, while upholding stringent quality standards.
A hallmark of Mr. Mazen’s career is his distinctive collaborative leadership style, forward-thinking mindset, integrity, unwavering commitment to continuous improvement and recognition as a change agent characterized by agility and resilience.  These attributes have established him as a respected professional in the industry.

Over the last 16 years of my career, I have developed strong working relationships with the various Ministries’ of Health (MOH) in the Middle East and thus consolidated my presence as a seasoned pharmaceutical regulatory affairs professional in the region.
I have completed my B. Pharm in 2002 from Dubai Pharmacy college and Master of Science in EU Regulatory affairs from KREMS , Vienna University and MBA from Preston University.
In 2013, I co-founded Professional Regulatory Affairs (PRA), a leading healthcare regulatory consultancy in the Middle East. To further uphold the ethics and compliance standards within the industry, I also persevered with Dubai Pharmacy College, industry experts and authorities to set up the GCC Regulatory Affairs (RA) Course, a first-of-its-kind certification, which educates graduates and professionals on the new career advancements and opportunities in this sector to become industry experts.
My true passion lies in helping authorities to find solutions and apply policies and regulations, which will lead to better health and safety within the regional communities. I have been instrumental in launching the GCC Regulatory Affairs Pharma Summit in 2015 and running it successfully for the last five years in Dubai. I also launched PHARMA REG AFRI summit , MEVAS and ACRAS summits in the region .
I am advisory board member with Dubai Pharmacy College and a member with the Women’s’ Business Council at the Dubai Chamber of Commerce.
I have been recently elected as a board member at Emirates Medical Association – Pharmacy chapter

Doctorate Degree in Toxicology-Algiers University (Algeria). Master Degrees in Quality Assurance and Quality Control.
A pharmacist with over 17 years of experience in both Pharmaceutical Industry within Middle East and Africa and Hospital Ground. Solid experience in Track and Trace including support to set up of global capabilities as well as impactful shaping of the dynamic legislative environment through active participation in the Track and Trace Taskforce; a key priority of the RAWG (PhRMAG).

She is the Regulatory Affairs Manager at Viatris Global Pharmaceutical Company.
Dr. Eman has 15 years diversity experience in regulatory affairs, quality assurance, pharmacovigilance & import/export pharma operation starting with Al Baker Distributor, UAE, expanding career professionalism to Responsible Quality Assurance Pharmacist with CHEMONICS Global Health Supply Chain (USAID Contractor) and with Valeant MENA.
active member in RA & QA groups.

Zeeshan Ahmed is the Founder and CEO of CosmoTrace Limited, U.K, a leading Life Sciences Consulting organization that offers Serialization & Traceability strategy consulting, implementation & integration services to the Pharma and other highly regulated industries.
He is an experienced Program Director, specialising in deploying Traceability and Serialization solutions globally. Prior to founding CosmoTrace, Zeeshan has worked across a broad spectrum of companies & sectors, including FMCG, IT and the Life Sciences.

Simge Sasmaz is a principal aligned to Consulting Services in IQVIA based in Dubai. Simge has strong expertise in consulting supporting local, regional, and international clients within the healthcare, including pharmaceutical companies, consumer healthcare clients and financial institutions. With over 15 years of pharma & strategy consulting experience in developed and emerging markets, she successfully led a wide range of consulting engagements, including geographic and therapy area expansion strategies, assessments for new therapies, portfolio prioritization, commercial due diligence, identification and evaluation of licensing opportunities and commercial design. Simge holds a BSc degree in Economics from Boğaziçi University and a masters’ degree in Economics from Sabancı University.

She is the Director Regulatory Affairs at Viatris, as an organization dedicated to empowering people worldwide to live healthier at every stage of life. Ms. Doa is passionate about raising awareness around cardiovascular, mental health,  respiratory diseases and diabetes and believes in shaping policy & regulations enhancement to improve patient access to their medicines & building trusted partnership with Board of Health.
Bringing 23 years of diversified experience in different multinational Pharmaceutical, Medical, Consumer Health companies (MSD, Novartis, Sandoz, Paul Heartmann, GlaxoSmithKline Consumer Health, Pfizer & Viatris) within sales, marketing, corporate affairs and communications & regulatory affairs departments, with proven success in engaging with different environments covering government, corporate, business and trade associations, directing and implementing regulation changes, policy shaping and corporate process enhancement.
Doa holds a bachelor’s degree in pharmaceutical science- Egypt.

Inas is a holder of Pharmacy diploma, and Master in EU and International Regulations and Healthcare Laws from Paris V University.
Inas has 17 years expertise in the European and Emergent markets regulations; she worked for various MNCs, and currently she is heading the regulatory department for MEA region in Novartis.
Her focus and interest is the Healthcare reforms and legislations, and policy shaping with main objective to accelerate patient access to innovative medicines.
Inas chaired the EFPIA regulatory group for 3 years; And she chaired the PhRMA association regulatory group for 4 years. She also chaired the program committee for the Middle East regulatory conference in 2019, and actively participating as a speaker in regional and international conferences.

Dr. Rabab Tayyem is the Executive Director and CEO of ACDIMA BioCenter. She has a BSc in Pharmacy in addition to MSc in Analytical Toxicology and obtained her postgraduate PhD degree in Drug Design and Medicinal Chemistry. Dr. Tayyem has more than 20-year experience in clinical and bioequivalence studies, after starting her career in pharmaceutical industry. Working in ACDIMA BioCenter for more than 17 years she culminated the experience from start and worked in different functions articulated in the core of regulatory sciences related to bioequivalence and bioavailability studies.

Om Kolthoom Mahmoud Weisy is a Senior Regulatory affair, Pharmacovigilance specialist & licensed pharmacist at Pharmalink drug store with a demonstrated history of working in a pharmaceutical drug store. She is responsible for the registration of all products categories (conventional, GSL, Medical devices) in the United Arab Emirates and GCC countries. Dealing with US & European markets requires strong knowledge of EMA, US FDA & ICH regulations.
Graduated from the University of Sharjah in 2018 with an excellent and honor degree. Currently, she is doing her master’s degree in pharmaceutical sciences – Pharmaceutics. She is collaborating with the local health authorities to do an epidemiological study on Helicobacter pylori, in addition, she is conducting different projects at the laboratory level. Familiar with Pharmacy management & training skills.

Puneet Kumar is a Supply Chain & Logistics leader, and is passionate to augment healthcare supply chain by designing digital and innovative solutions.

He is an MBA, has an Engineering background, and believes in the principles of Lean, Six Sigma and agile methodologies.
He has diverse experience across various geographies as well as various industries like Shipping, Transportation, Electronics, Manufacturing, Oil & Gas and Healthcare.
He is currently with Roche Pharmaceuticals, based in Dubai UAE, as Supply Chain and Logistics Lead with additional roles as:
• Digital Transformation Lead, as well as
• as Supply Chain Business Partner for CMA
[CEETRIS -Central & Eastern Europe, Turkey, Indian Sub-continent, Middle East and Africa]

He has vast experience in creating innovative digital supply chain solutions as well as models and processes for Working Capital and Inventory management, Value chain management, Process re-engineering, Lean methodology and Logistics & Supply Chain Management of Temperature controlled products and associated machineries.

He is a highly motivated and passionate individual who wants to make a difference in peoples’ life. Continual and sustainable growth is his true calling. Currently he is looking to explore and utilize the potential of digitization in Supply Chain, fostering ecosystem-networked approach with End-to-End optimization mindset to make a difference in patients’ and caregivers lives.

Neeraj Pant is Co-founder and director of DDReg Pharma – A global Regulatory and Pharmacovigilance Services organization. Neeraj is a Proven Regulatory, Medical Affairs & Clinical Research executive with consistent achievement in identifying growth opportunities, delivering sustainable competitive advantage and driving quality compliance. Before DDReg Neeraj has had Strong corporate experience of 21 years of handling and heading RA functions with leading global pharma organizations like Ranbaxy Labs Ltd (erstwhile), Pfizer, Johnson & Johnson & RB and managing different spheres of regulatory affairs like Rx, OTC, Cosmetics, Food Products, Medical Devices & Household Pesticides. Repeatedly appointed into senior leadership roles based on demonstrated success in defining and executing short and long term strategy, directing product development, regulatory strategies and clinical research initiatives and leading regulatory teams. Astute business and regulatory strategist with expertise in optimizing P&L, building and motivating top-performing teams and building relationships with Key Opinion Leaders.

Yousra a Regulatory Affairs and Commercial & Distribution Quality Assurance Head with over 16 years of diversified experience from various leadership positions in Regulatory Affairs and Quality Assurance within Health Authority as well as multinational organizations at both regional and local levels.
Yousra is currently leading Abbott-Gulf & Emerging Markets Regulatory Affairs & Quality Assurance. In her role in Abbott Established Pharmaceutical Division; Yousra is responsible for setting Regulatory Strategies for New Product Introduction, Geo-expansion, Licensing & Acquisition, Localization, Life cycle management, enhancement of promotional model, as well as RA risk mitigation and regulatory compliance.

With over 20 years of corporate Market Access, Regulatory Affairs and Regional Management, Dr. Marielouise Abi Hanna, PharmD, spent her career in Pharma, Biotech and Generics both in Global and Regional roles throughout International Regulatory Affairs, Quality, Medical and Market Access, for major Multinationals among which GlaxoSmithKline and Novartis’ Sandoz business unit.
She founded The Reg.Cloud in 2018, a Pharma consultancy that specializes in Due Diligence and Audits for Merger & Acquisitions, Market Access and Regulatory Programs across the product lifecycle. The Reg.Cloud supports Small to Medium-sized Pharma Enterprises as well as established Multinationals to expand their geographical coverage, with a primary focus on Middle East, Africa, Asia Pacific, CIS and Eastern Europe.

Dr. Eslam Abdo holds bachelor’s in pharmacy. After graduation he got postgraduate Doctor of Pharmacy Degree. Dr. Eslam has broad knowledge in the international drug regulatory affairs. He joined MOHAP, UAE in 2018 as a Regulatory Affairs Specialist in Drug Registration Department.
He covers many areas in his current role including New Drug Registration, Renewals and minor variations applications. Dr. Eslam is participating in many guidelines being issued MOHAP.

He is the Head of Serialization & Digital Enabling, Manufacturing Systems, Global Engineering at Takeda Pharmaceuticals, and Owns UPI (Unique Product Identifier process and system) and DA (Digital Authentication) process end to end to ensure compliance and patient protection, He Drives business value beyond pure compliance to leverage technology implemented Drives new technology to support DA and UPI/Track and Trace initiatives and Ensures new technology is embedded in our standard equipment in collaboration with head technology. Mr. Michael also monitors and improves OEE related to UPI/DA to ensure supply to patient. Previously he was the Cross Divisional Program Leader, Serialization & Tamper Evident at Novartis, and he was the Leader of a global USD$258M program spanning across 37 sites and 250 CMOs worldwide. He was also responsible for the design and definition of standardized templates coving Serialization & Product Tracking and Tamper Evident Packaging processes across the entire Novartis domain.

Varun offers Management Lead for Forge Track & Trace in Honeywell. Prior to Honeywell, he has worked with GE for their digital solution business and Nokia Siemens Networks for the communication technology business. In addition, he is an Alumni of the prestigious “Commercial Leadership Program” from GE. As for his education, he has a Bachelor of Electronics for NIT Surat, India and MBA in Marketing from IMT Ghaziabad, India. He has 11 years of Diverse experience in Industrial software solutions in Logistics, Connected Industrial and Transportation domain.

He am a regional Quality Director and member of strategic global quality team with over 21 years of diversify experiences in quality, supplier/EMO quality, manufacturing, commercial affiliates and distribution within the Medical Device and Pharmaceutical industries . His quality experience was acquired in the United States, GHC region and China. This enabled me to acquire an extensive experience and knowledge in the implementation of a robust Quality Management Systems in accordance to USFDA, Health Canada, SFDA GMP, Medical Device regulations. He has a track record of outstanding HA inspection results.
He worked closely with various business partners in leading new products launch, geo-expansion, technology transfer and Procurement projects transition to outsourcing operations in the USA and China effectively with track record for remaining within the project timelines/cost and compliance.  He transformed many company’s business culture to foster the required Multinational quality culture to improve overall processes and support business strategic plans.
Furthermore, He lead the development and optimization of QMS for internal manufacturing sites, commercial affiliates, EMO business partners, distribution centers and new acquisitions to enhance operations excellence & compliance level. This was achieved by using practical knowledge and expertise to integrate lean manufacturing principles (kaizen tools) within a regulated environment, assuring Quality System compliance and harmonization, reducing product defect rate and achieving product cost avoidance. Recently, he was appointed to lead the global initiatives to develop strategic quality 4.0 digitalization roadmap which expect to enhance the internal capabilities by apply proactive quality as part of operational excellence program.

Sattam Turky Alghodyyr began his career as a pharmacist at King Khalid Hospital, AIMajma’ah, but soon moved to the Saudi Food & Drug Authority gaining unparalleled experience in the Bioequivalence, while also establishing himself as an expert inP harmacovigilance.
In 2016 he started at Saudi Pharmaceutical Industries and Medical Appliances Corporation-SPIMACO as the Pharmacovigilance and Bioequivalence Manager where he is now Director of Regulatory Affairs.
Sattam is the Founding Member of the Pharmaceutical Industry Association PIA, Member of the Board of Directors ARAC Healthcare Oct 2018 and a Committee member representing SPIMACO on the National Committee for Pharmaceutical Industries NCPI.

Rami Habbal is the Chief Executive Officer of GS1 UAE and serves on its Board of Directors. His appointment in 2020 followed almost a decade with the organization in which he was responsible for the organization’s growth and digital transformation.
Rami brings 25 years of experience in leadership and operational management. He has spearheaded the building of long-term strategic relationships with government authorities and industry organizations. His efforts have earned him recognition as a leading voice in the adoption of GS1 standards across the GCC region.
Rami is part of several government committees and advises authorities on various topics related to global standards, digital transformation, and traceability.  Rami is also an active participant in the regional entrepreneurial community, where he serves as a mentor and a board member for several start-up companies. He is a strong advocate of digital transformation through the adoption of standards.

• Senior Clinical Research Manager at Hikma Pharmaceuticals with more than 26 years’ experience in Pharmaceutical Industry in MENA region.
• BSc Pharmacy-Jordan University of Science and Technology, MBA-University of Leicester
• Certified Project Management Professional (PMP) since 2007
• Certificate in Clinical Research-Harvard Medical School
• Responsible for the planning, conduct and management of Hikma clinical endpoints studies and Bioequivalence studies in MENA region
• Areas of special interest include Hematology and Oncology, Biosimilars
• Active Volunteer in Atfaluna Association for Children Medical Coverage
• Inspired daily by my family. In my free time, I like to exercise and read.

• Global Head of Clinical Research and Head of R&D for MENA at Hikma Pharmaceuticals with more than 30 years’ experience in Pharmaceutical Industry Worldwide.
• MSc Pharmacy University of Iceland
• Previously worked at TEVA, Allergan, Watson and Actavis
• GCP training from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom 2017
• Executive Coaching from SuTra Coaching, Belgum 2016
• Leadership for Leaders University of Iceland 2015
• Monitoring of Clinical studies – Barnett international, Needham, Massachusetts, USA 2012
• Bioanalytical Monitoring – PharmaSys Inc. Cary, North Carolina, USA 2011
• Responsible for the planning, conduct and management of Hikma clinical endpoints studies and Bioequivalence studies Worldwide
• Responsible for Developing Hikma products for the MENA region
• Outside of work, special interest for football and chess

Lamis Youssef is the Senior Regulatory Affairs Manager, Gulf cluster in Pfizer. She has over 11 years of experience in Regulatory Affairs (RA) across the pharmaceutical industry. She joined Pfizer in 2016 as Regulatory affairs manager handling Africa middle east region for a diverse portfolio & was responsible for the Regulatory management of Hospira acquisition within Africa middle east region. In her current role Lamis is handling multiple therapeutics areas for innovative portfolio.
She is also an active member within the Gulf trade association and is currently leading the Trak & Trace and e-labelling taskforce within Regulatory Affairs working group.
Before joining Pfizer, Lamis worked as regulatory affairs for J&J medical devices and  Julphar, prior joining regulatory she had different roles working as production and quality assurance expert in different pharmaceutical companies in Egypt including Sigmatec and GSK.
Lamis graduated from faculty of Pharmacy 6^th October university, she has a six sigma green belt certificate and she is currently pursuing her MBA.

Hala Abu Ghazalah, Head of Regulatory Affairs, Africa & Middle East
Pfizer Biopharmaceutical Group with 25 years of experience in Regulatory Affairs, External Affairs, and Marketing, supporting various healthcare categories.
Pharmacist by education, licensed in both UAE and Canada.

Amani Mansour is currently the Head of Regulatory Affairs, Gulf cluster in Pfizer. She has  over 12 years of experience in Regulatory Affairs (RA) across the pharmaceutical industry and governmental sector. She  joined Pfizer in 2011 and handled different roles within the regulatory team in Pfizer starting with above country role supporting Africa middle east region moving to an in-country role where she was leading the regulatory team within gulf and levant and Currently Amani is heading the regulatory affairs organization within Pfizer gulf.
She is also an active member within the Gulf trade association and is currently the Regulatory Affairs Working Group (RAWG) Co-Chair and is leading the Digitalization taskforce within Middle East Regulatory Network group.
Before joining Pfizer, Amani worked with the Ministry of Agriculture in Lebanon as Regulatory Affairs specialist.
Amani graduated from faculty of science in Saint Joseph University in Lebanon and holds 2 Master’s degree in Food Chemistry & Agro-economics.

Ibrahim is currently the Regulatory Affairs Director of gulf countries (UAE, Kuwait, Qatar, Oman, Bahrain & Yemen) at AbbVie for more than 7 years.
Ibrahim started his career back in the year 2004 with Amman Pharmaceutical industry as a microbiologist analyst in the quality control unit, Ibrahim then moved to Tabuk Pharmaceutical Company local Saudi company, then moved to Hospira in UAE as a regulatory affairs covering MENA region.
Prior to joining AbbVie, he worked in regulatory affairs at DANONE Baby Nutrition.
Ibrahim has more than 17 years of experience in the Regulatory affairs and Quality control field.
Ibrahim holds a Bachelor’s degree in Biological Sciences from Jordan University in Amman.

A pharmaceutical industry executive with more than 18 years of experience in both public and private Pharmaceutical Sector. Pharmacist by education, obtained master’s degree in public policy from the American University in Cairo

Led key initiatives in development and implementation of pharmaceutical regulations, planning and implementation of Health system reforms, and shaping regulatory policy.
As a former General Director of health products and Biopharmaceutics Registration Department, represented Egyptian Drug Authority in regional and international scientific and policy discussions with Health Agencies and WHO. Held other several key positions in the public pharmaceutical sector such as Director for the Pharmaceutical Supply Reform National Program and Policy Technical Office Director.
Led and coached big teams, taught pharmaceutical policy and regulations, and inspired and motivated young professionals to accomplish and grow.
Innovation Ambassador and Certified Speaker Coach.
Founder in STEM her Up, STEM mentoring foundation for women and girls in Egypt

Head of Regulatory Affairs Middle East & Scientific office Manager at Takeda Pharmaceuticals.
Nawel Boukhatem with 13 years experience within the pharmaceutical industry in regulatory Affairs across 4 different regions Middle East, Egypt & South  Africa & North Africa. Nawel  is currently the Head of Regulatory Affairs for Middle East region and sitting in strategic discussion within ICMEA (India -Middle East-Maghreb, Egypt & South Africa, UCC & Turkey)  in Takeda pharmaceuticals  Company Limited (TSE:4502/NYSE:TAK) a global, values-based, R&D-driven biopharmaceutical leader with headquarters in Japan, committed to bringing better health and a brighter future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on the following therapeutic areas: Oncology, Gastroenterology, Rare Genetic & Hematology diseases, Neuroscience and globaly Plasma- Derived Therapies and Vaccines.
Before joining Takeda Pharmaceuticals company, Nawel was Regulatory Affairs Associate Director at Shire pharmaceuticals for Middle East and Africa before Takeda acquisition.
Prior Shire Nawel was regulatory affairs manager at Baxter pharmaceuticals for 3 years.

• She is a strong Regulatory Business Partner driver for results and a team player in any project she is part of it to enable different product launches and business expansion in fastest but in safer manner to help our patients across our countries to access to innovative products ; being energetic self-motivated person who spreads positive energy in any team she is part of;
• Nawel, inspires her colleagues and develop her team to perform at their best by building a positive work environment for talent development and growth, living their personal values in everything they did and giving back to patients.
• She enjoys working with diversed individuals from different cultures and disciplines including remote teams, learning new ideas and coaching others to address requirements from diverse stakeholder groups, including internal business partners, external suppliers and governmental organizations.
• Nawel sets high standard of results for her self and the team and succeeds to get their engagement and commitment.
• She has an excellent knowledge of pharma environment, regulations in Middle East and North Africa countries;

Jeffrey P. Kemprecos, BA, MA, MIBS, is Director of Communications, Government Affairs & Market Access at GSK, a globally-leading healthcare company.
Mr. Kemprecos is based in Dubai, United Arab Emirates, where he leads GSK’s policy advocacy across a wide range of health and pharmaceutical industrial issues.
The scope of this work includes healthcare reform, intellectual property and trade-related issues, access to innovative medicines and vaccines, and regulatory harmonization.  Policies and legislation affecting competition, investment and innovation in the pharmaceutical sector constitute a primary focus.  Public policy work comprises two complementary missions—advocating legislation, regulations and policies that advance human health and strengthen the innovative medicines sector.
Mr. Kemprecos has worked in the innovative biopharmaceutical industry across a variety of countries and regions for almost 30 years, including the Eastern Europe, Middle East, Africa, Latin America and Asia/Pacific regions, leading government affairs, public policy, communications and market access teams responsible for up to 140 countries.
Mr. Kemprecos is currently serving in his second term as Chairman of the Intellectual Property Committee for the Pharmaceutical Research & Manufacturers Association in the Gulf (PHRMAG), Leader of the PHRMAG DOH Engagement Group, and is a member of the U.K. Business Council’s Healthcare and Life Sciences Working Group and the US Chamber of Commerce Gulf Business Council and Oman American Business Council. He also serves on the Abu Dhabi DOH Undersecretary’s Healthcare Council.
Mr. Kemprecos is a native of Massachusetts.  He speaks Arabic, English, Turkish and French.  He is the father of 3 vivacious daughters and an avid fan of vintage automobiles.

BSc in Pharmacy from Jordan University, 1991
MSc in drug analysis from Monastir University, Tunisia, 1998
PhD in Pharmaceutical sciences from University of Lille II, France, 2005. PhD thesis was awarded with distinction and it was nominated for “State Prize” at the Pharmaceutical Academy in Paris.
I have been working in the pharmaceutical industry for around 30 years. Joined Hikma Pharmaceuticals in 1991 and worked in different technical departments, with many years of hands-on experience in the formulation and process development, as well as analytical development of oral and injectable generic products. I held the position of Technical Director in Medicef (a newly established sister company for Hikma in Tunisia) for seven years, where I established all the technical departments: QA, QC, Product Pipeline, technical transfer and Regulatory Affairs. I also headed the Research and Development – Injectables department in Amman for around 10 years and successfully developed and registered new generic products targeting global markets in USA, EU and MENA.
Other Activities in the Educational Field:
Jordan University of Science and Technology-Deanship of Scientific Research:

• Member in the “Scientific Research Committee” during the scholar year 2019-2020.

Yarmouk University:

• Member in the Faculty of Pharmacy board during the scholar year 2018 – 2019.

Jordan University of Science and Technology (JUST) & Yarmouk University:

• Deliver lectures to 5^th year Pharmacy students on the application of certain concepts and technologies in the pharmaceutical industry, focusing on bridging the gap between theorical knowledge and practical application (started in 2017 till now).

Jordanian Association for Pharmacists:

Received an appreciation and recognition award from the “Jordanian Association for Pharmacists” for the significant contribution to the development of pharmaceutical industry in Jordan (March 2019).

Baha AbuSalem is the Program Director of Tatmeen at EVOTEQ. Tameen, an initiative of the Ministry of Health and Prevention, is a highly advanced track and trace platform for pharmaceuticals and medical products based on EVOTEQ’s SmartTrack solution. This program will ensure the protection of public health and improve the security of healthcare at all stages.
A seasoned IT executive, AbuSalem has led large-scale projects in several verticals including government, telecommunications, transportation, and logistics. He has been driving innovation and delivering value-added experiences to companies through new and relevant technologies. AbuSalem holds an MBA from the University of Strathclyde, UK.

Qutaiba Al Manaseer, is a Public affairs professional drawing on more than 16 years’ experience in the biopharmaceutical industry. He is the Corporate Affairs Director for the Middle East and Africa.
Qutaiba serves in the Emirates Health Economics Society board as the Media and Public Relations Chairman.
Qutaiba holds a master’s in health economics from Barcelona School of Management, an MBA from the Swiss Business School, Switzerland and a bachelor’s degree in Pharmacy from the University of Jordan.

As Rafed’s Chief Commercial Officer, Ahmed Al Bastaki, with more than 28 years of professional experience encompass a wide scope in the field of healthcare & project management across the UAE and Internationally in both the government and private sectors. Having developed a wealth of knowledge & experience working on ambitious projects in the field of healthcare and supply chain management throughout his career, Ahmed’s duty includes steering major operational projects on behalf of Rafed and leading the Strategy Division, in addition to being a key driver in the collaborative effort across the company and its departments making sure Rafed is achieving above and beyond its objectives as a leading GPO.
In his prior role at Abu Dhabi Healthcare Services Company SEHA, Ahmed was responsible for leading, planning and monitoring major operational projects such as leading the complete transfer of medical services management of the Abu Dhabi Police Clinics to SEHA. He was a key member of the activation Steering Committee of Sheikh Shakhbout Medical City, the 743 bed state-of-the-art hospital in partnership with Mayo Clinic. He was also responsible for several other prominent supply chain projects including the SEHA Central Warehouse, SEHA Central PPE Procurement and Global Consumables Supply Chain, while also performing due diligence, setting strategies and effective optimization to ensure achieving the anticipated outcomes.

She has a BSc in pharmacy from Jordan University of science & technology in 2003 and a MSc in pharmaceutical quality assurance/quality control from Jordan University of science & technology in 2006. Pharmacist Rana was the former registration officer in Jordan pharmaceutical manufacturing company (JPM) and former to that she was the section head of Biological drugs, sera & vaccines in the registration department at JFDA. Currently, she is working as Head of clinical studies department.
Her previous work experience involved the assessment & review of CTD files of originator drugs, vaccines & biological drugs, Receipt & assessment of post approval changes regarding registered biological, originator drugs & vaccines, Intellectual properties & public health issues related to pharmaceuticals. She collaborated in the team for the preparation & review of the “Guidance for Registration of Biosimilars in Jordan” that was published in May,2015 as the national guidance in the official gazette. In addition, she reviewed & approved of the Clinical studies protocols for studies submitted to be conducted in Jordan.
Currently, her work responsibilities consist of Reviewing the applications for accreditation of centers (CROs), hospitals, laboratories (both diagnostic & analytical) involved in the conduct of clinical trials/BE studies, as well as the Inspection of the sites (for accreditation & during study conduct), to ensure continuous adherence to standards & requirements and reviewing therapeutic & nontherapeutic protocols to ensure compliance to requirements.

Dr. Eman Al-Awamleh was graduated from Jordan University of Science and Technology – Jordan; she received her BSc. degree in pharmacy in 1999. She worked as a Pharmacist at Community Pharmacies (1999-2009). She joined JFDA in 2010, at (Regulatory Affairs) Registration Department in Drug Directorate and became a specialist pharmacist in 2016. She is now a Senior Pharmacist and a head of Research and Scientific Advice Section in Drug Directorate. She had participated in many Registration Committees in JFDA, and she had many Presentations in many Conferences.

Dr. Mona has a Bachelor degree in pharmdraceutical science and pharmaceutical manufacturing, Head of new medicine registration Unit. She is a member of registration and pricing technical committee, member of GCC medical device committee and she has worked on many tasks, worked as registration application reviewer (new, renew and minor variations), Medical device registered in GCC Council, GMP inspector and pharmacovigilance officer.

Ali Alajme is the Digital Health Department Director in Ministry of Health and Prevention, and he played a vital role in leading national initiatives such as track and trace of medicine and UAE national unified medical record. He also lead Digital Patient Platform (Shefaa) which was awarded as the best Digital platform in World Summit of Information Society 2021. Ali Alajme was awarded as the winner of CIO of the year 2020 by the IDC and was chosen as top 50 CIO by IDG .inc in Middle East due to his role in leading technical vital projects in COVID 19 Pandemic. He is an Alumni of UAE leadership program (Qiyadat) in executive leaders, Mohammed Bin Rashid Government Innovation program and UAE government experience Exchange Trainers Program from Prime Minister Office of UAE. Ali Alajme has almost 16 years of experience in diverse sectors and he has a Master Degree in Business Administration from Higher Colleges of Technologies and a International Certified Balance Scorecard from Palladium.

Mr. Babiker has more than 20 years of experience in different fields of pharmacy practice including hospital pharmacy, community pharmacy, clinical pharmacy, drug information, patient safety, quality and risk management. He has presented many papers in international scientific conferences and published an original research article in reputable Journal.
Mr. Babiker is a pharmacist with initially a degree from Sudan, which he substantiated by doing additional internationally, recognized examinations. He has research experience through a Master program at Queens University Belfast in the United Kingdom. His research interests are in the areas of patient safety and pharmacy practice.
He has worked as drug information pharmacist at Hamad Medical Corporation, the principal health institute in Qatar, which contributed to his clinical knowledge and skills. Through his work for the Ministry of Public Health, especially the Community Pharmacies Steering Group for the National Health Strategy Project 1.6 Community Pharmacies Strategy and as vaccine registration supervisor, he also has experience with the development of policies.
In addition, Mr. Babiker is interested in sport activities; he was volunteering with Qatar Anti-doping Commission as a Doping Control Officer (DCO) since 2005. He participated in many and different sports activities in Qatar such as DCO, education & outreach program as well as DCO Venue Manager.

Dr. Donia Al Bastaki is the head of drug registration department with more than 17 years working experience in the pharmaceutical field, her area of expertise is regulatory affairs and pharmacovigilance where she contributed to the development of drug regulatory framework in Kuwait and GCC.
13 years’ experience in GMP inspection through which she inspected several international, regional, and local pharmaceutical manufacturing companies.
Member of GHC Central Registration Committee since year 2007 till 2018 and contributed to setting the GCC Guidelines for Drug Registration as well as Stability, Bioequivalence and PIL GCC guidelines and others.
Member of the International Society of Pharmacovigilance and Kuwait deputy focal point for Uppsala Monitoring Center /WHO Collaborating Center for International Drug Monitoring.
She was assigned as Kuwait focal point with the League of Arab states in the field of Pharmacy and drugs and participated in the development of the Arab common Bioequivalence Guidelines.

Mrs. Nisreen Nassr is an Omani Senior specialist pharmacist, holding a Master degree in pharmaceutical Sciences. Her research was focused on Drug Discovery. In October 2015, she was appointed as the head of registration of Pharma products in the MOH, Oman. She is a member and secretary of the technical registration and Pricing committee in MOH Oman, Bioequivalence committee and the National Committee of Pharmacovigilance.  Her responsibilities include policy development regulatory affairs and capacity building. Prior to this role and since 2002, Mrs.
Nisreen handled various tasks as she was the Section of Controlled Medicines, GMP inspector, registration applications reviewer, and handled pricing. In 2007, she effectively contributed in the with WHO/HAl survey on medicines prices availability and affordability.

External Medicine Dossier Assessor at Ethiopian Food and Drug Authority (EFDA) and
the Co-founder & Vice President of East Africa Regulatory Affairs Professionals Association (EARAPA). Mr. Nathan is also an assistant lecturer at the Addis Ababa University, School of Pharmacy, Department of Social Pharmacy and Pharmaceutics, Medicine Regulatory Affairs program.
He graduated from Clinical Pharmacy at the Addis Ababa University, and he’s currently finalizing his Master’s Degree in Medicine Regulatory Affairs.
I am an academician at the School of Pharmacy, in the Department of Pharmaceutics and Social Pharmacy.

Myriam Razgallah Khrouf is a Professor of Pharmacology at the Faculty of Pharmacy (University of Monastir) and Director of the Unit of Pharmacy and Drug at the Ministry of Health in Tunisia.
Graduated from the Faculty of Pharmacy of Monastir and specialist in hospital and industrial pharmacy. She obtained her master in pharmacokinetic and she performed her interneship in pharmacology in Tunisia and in France, mainly within the federation of pharmacology at Marseille.
After a short experience as project manager in clinical trials in a multinational pharmaceutical laboratory in France she was appointed as pharmacokinetic assessor within the Drug French Agency « ANSM » (formerly called AFSSAPS).
In 2011 she came back to Tunisia to start her hospital-university career, with a large experience in hospital pharmacy department.
In 2016, with a multidisciplinary team composed of teachers, practitioners, economists, experts and industrialists, she set up a postgraduate diploma in pharmaco-economics within the faculty of Monastir pharmacy.
In 2016, with a multidisciplinary team composed of teachers, practitioners, economists, experts and industrialists, she set up a postgraduate diploma in pharmaco-economics within the faculty of Monastir pharmacy.
In December 2018 she was appointed as director in the Unit of Pharmacy and Drug within the Tunisian Ministry of Health.
During the COVID Crisis she participated actively in the coordination of vaccine registration, in the enrollement of Tunisia in COVAX initiative and in the World Bank financement process.
Since 2020 she was elected to be member of the scientific council of the faculty of pharmacy of Monastir,in Tunisia.
She give several conference in regional and international congres and published several articles in the field of hospital pharmacy and pharmacology.
Since 2021 she became EML expert WHO.

She holds B.Sc. Degree in Pharmacy from Jordan university of science       and technology, 2014, and she has seven years’ experience as a regulatory affairs pharmacist, three of them in a private sector including international company and drug store. Ms. Bayan joined Jordan FDA in 2018, as a pharmacist in the drug registration department – Originators/ biological and biosimilar Drugs Unit. In addition, she is an active member in the following committees at Jordan FDA:

• Committee  for evaluation and registration of Originators/ biological and biosimilar Drugs.
• Post-approval changes committee

Dr Mariam Al-Jalahma was appointed by His majesty the King of Bahrain, in 2015 as the Chief Executive Officer of the National Health Regularity Authority in the Kingdom of Bahrain. She is as a member of the supreme council of health in Bahrain, and is appointed by the prime minister as a member in Academic accreditation Committee of the supreme council for Higher education in 2016.
Previous positions:

She was holding the position of Assistant Undersecretary for Primary Care and Public Health until 2015, and was a member of the Executive Board of The Health Ministers’ Council for GCC States until 2016.
A member of the Sura Council in 2000, and a member of the National Institute for Human rights. Dr. Al-Jalahma worked as an advisor for the world health organization in the fields of Adolescents and Non communicable diseases (NCDs).
Qualifications:· Arab Board certificate in Family & Community Medicine in 1990
· Higher studies diploma in medical education from Dundee University in Scotland in 1994
· Diploma in Health Care Management from Royal college of surgeon in Ireland in 2000
Honorees & medals
· In December 2011 she was awarded an honouree medal of efficiency by his majesty the king of Bahrain.
· In 1990 Awarded by the prime minister awards for leaders of Moharraq.
· In 2009 she was awarded by Her Highness Shaikha Sabika Bent Ebrahim Al-Khalifa the Princess of Bahrain and Chairperson of Woman Supreme council the award of National Woman day Celebration, the award is presented to women leaders in health.
· In June 2011 she is awarded by the regional office for eastern Mediterranean of the WHO the Anti-tobacco award of the region.
· Global award for health pioneers from UAE
· GCC leaders Award 2019

His Excellency Dr. Amin Hussain Al Amiri is the Asst. Undersecretary of Public Health Policy &amp; Licensing Sector in UAE Ministry of Health &amp; Prevention<br>
Dr. Al Amiri got his Ph.D. and Ms. C. in Medical Science in 2003 from Faculty of Medicine; Aberdeen University in Scotland; UK.<br>
<b>He is responsible for the following departments at MOHAP:</b>• Drug Dept.<br>
• Empowerment &amp; Health Compliance Dept.<br>
• Organization, Licenses&amp; Advertisement Dept.<br>
• Public Health Policies Dept.

An experienced professional with in depth knowledge in different regulatory fields related to product regulations that include Medical devices , pharmaceuticals, Biologicals , herbal products, nutritional products, medicated cosmetics and other related product classes (FMCG), A member of multiple technical and policy making teams on a national & regional scale ,most of these teams are joint groups with different authorities from all across the UAE/ GCC like ESMA/HAAD/DHA/ DM / GCC Health Council. Has a wide experience in different areas as regulatory affairs / market access / regulatory compliance and government affairs in the GCC & MENA regions.

Dr Mariam Al-Jalahma was appointed by His majesty the King of Bahrain, in 2015 as the Chief Executive Officer of the National Health Regularity Authority in the Kingdom of Bahrain. She is as a member of the supreme council of health in Bahrain, and is appointed by the prime minister as a member in Academic accreditation Committee of the supreme council for Higher education in 2016.

<b>Previous positions:<br>
</b>

She was holding the position of Assistant Undersecretary for Primary Care and Public Health until 2015, and was a member of the Executive Board of The Health Ministers’ Council for GCC States until 2016.<br>
A member of the Sura Council in 2000, and a member of the National Institute for Human rights. Dr. Al-Jalahma worked as an advisor for the world health organization in the fields of Adolescents and Non communicable diseases (NCDs).<br>
Qualifications:· Arab Board certificate in Family &amp; Community Medicine in 1990<br>
· Higher studies diploma in medical education from Dundee University in Scotland in 1994<br>
· Diploma in Health Care Management from Royal college of surgeon in Ireland in 2000<br>
Honorees &amp; medals<br>
· In December 2011 she was awarded an honouree medal of efficiency by his majesty the king of Bahrain.<br>
· In 1990 Awarded by the prime minister awards for leaders of Moharraq.<br>
· In 2009 she was awarded by Her Highness Shaikha Sabika Bent Ebrahim Al-Khalifa the Princess of Bahrain and Chairperson of Woman Supreme council the award of National Woman day Celebration, the award is presented to women leaders in health.<br>
· In June 2011 she is awarded by the regional office for eastern Mediterranean of the WHO the Anti-tobacco award of the region.<br>
· Global award for health pioneers from UAE<br>
· GCC leaders Award 2019

Mrs Nisreen Nassr is an Omani Senior specialist pharmacist, holding a Master degree in pharmaceutical Sciences. Her research was focused on Drug Discovery. In October 2015, she was appointed as the head of registration of Pharma products in the MOH, Oman. She is a member and secretary of the Technical registration and Pricing committee in MOH Oman, Bioequivalence committee and the National committee of Pharmacovigilance. Her responsibilities include policy development regulatory affairs and capacity building.

Prior to this role and since 2002, Mrs. Nisreen handled various tasks as she was the Section of Controlled Medicines, GMP inspector, registration applications reviewer, and handled pricing. In 2007, she effectively contributed in the with WHO/HAI survey on medicines prices availability and affordability.

Bachelor degree in pharmaceutical science and pharmaceutical manufacturing , Head of new medicine registration Unit.

She is a member of registration and pricing technical committee, member of GCC medical device committee.

Worked on many tasks, worked as registration application reviewer (new, renew and minor variations) , Medical device registered in GCC Council , GMP inspector and pharmacovigilance officer.

Samia Kanawati is an experienced&nbsp;and highly respected&nbsp;communications professional&nbsp;in the region,&nbsp;that brings with her more than 15 years diversified&nbsp; experience in Communications, Public Affairs and Regulatory in many therapy areas including rare diseases, HIV, oncology, respiratory, eye care and medical aesthetics&nbsp;among others.

She oversees 40 countries in EEMEA as part of her remit in leading Allergan Aesthetics-an AbbVie company&nbsp;internal and external&nbsp;communications efforts across several practices-&nbsp;including public affairs, social and digital communications,&nbsp;public relations,&nbsp;patient advocacy group relationships as well as crisis communications, dealing with a wide range of stakeholders such as health authorities, medical societies and associations.

What distinguishes Samia Kanawati is her entrepreneurial mindset and dynamic approach not only in her daily tasks but also on a personal level.&nbsp;When she’s not wearing her communicator hat, Samia&nbsp;is passionate about empowering women to play active roles in their communities and loves to join gala events and be part of public awareness initiatives.

Prior to joining Allergan, Samia ran the regulatory and communications functions at Shire Middle East, where she built robust relationships with regional authorities and associations while also advising the company on brand strategies focused on consumer activations. During her tenure she developed a detailed understanding of the legal framework, processes and legislative agendas of regional policy-makers and was influential in communicating Shire’s point of view in the region.

Samia graduated from the University of Jordan with a degree in Pharmacy. She holds an Executive MBA from Bradford University, School of Management in the United Kingdom, as well as a diploma in bio pharmacy from The Martin Luther University of Halle Wittenberg, Germany. She is fluent in English, Arabic and French

Five Achievements

Samia’s passion for diversity and inclusion has enabled her to lead the women in leadership initiative, positioning Allergan&nbsp;as&nbsp;‘Winner of the most Women Friendly Employer Award’&nbsp;in October 2019 by Naseba Foundation.&nbsp;Her contribution to policy shaping to provide innovative approach enabling early access to medication enabled her to participate with Allergan in launch of UAE Ministry of Health and Prevention innovations’ s strategy hence receiving an “ Appreciation” For Allergan participation in event in January 2019.</p>
<p>Giving back to the community is at the heart of her endeavors. Samia has led a multitude Corporate Social Responsibility campaigns&nbsp;such as World Glaucoma Week, World Primary Immunodeficiency Week, World Hemophilia Day and International Women’s Day in both Allergan 2018 and Shire 2017.

Moreover, she has coveted many awards including&nbsp;the&nbsp;International Powerhouse Award for the Women in Leadership initiative by Allergan, the&nbsp;Best Project Management&nbsp;Award&nbsp;according to Shire&nbsp;and&nbsp;the Silver&nbsp;Award for Partner of Choice to the Business during her tenure at GlaxoSmithKline (GSK).

Five Achievements

Samia’s passion for diversity and inclusion has enabled her to lead the women in leadership initiative, positioning Allergan as ‘Winner of the most Women Friendly Employer Award’ in October 2019 by Naseba Foundation. Her contribution to policy shaping to provide innovative approach enabling early access to medication enabled her to participate with Allergan in launch of UAE Ministry of Health and Prevention innovations’ s strategy hence receiving an “ Appreciation” For Allergan participation in event in January 2019.

Giving back to the community is at the heart of her endeavors. Samia has led a multitude Corporate Social Responsibility campaigns such as World Glaucoma Week, World Primary Immunodeficiency Week, World Hemophilia Day and International Women’s Day in both Allergan 2018 and Shire 2017.

Moreover, she has coveted many awards including the International Powerhouse Award for the Women in Leadership initiative by Allergan, the Best Project Management Award according to Shire and the Silver Award for Partner of Choice to the Business during her tenure at GlaxoSmithKline (GSK).

Yousra a Regulatory Affairs and Commercial &amp; Distribution Quality Assurance Head with over 16 years of diversified experience from various leadership positions in Regulatory Affairs and Quality Assurance within Health Authority as well as multinational organizations at both regional and local levels.

Yousra is currently leading Abbott-Gulf &amp; Emerging Markets Regulatory Affairs &amp; Quality Assurance. In her role in Abbott Established Pharmaceutical Division;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Yousra is responsible for setting Regulatory Strategies for New Product Introduction, Geo-expansion, Licensing &amp; Acquisition, Localization, Life cycle management, enhancement of promotional model, as well as RA risk mitigation and regulatory compliance.

Yousra has set effective regulatory strategies of external engagement including Health authorities, local distributors, trade associations and Third-Party Manufacturers. This is in addition to her Quality Assurance responsibilities of establishing and embedding Quality Management System within GEM. Institute of Technology, USA which upgraded her strategic thinking and enhanced her development.

Yousra is holding a bachelor of Pharmaceutical sciences from Cairo University and RAPS-DPC certification/USA-UAE and She has also completed the “New Leadership Program (NLP)”, by Harvard Business School and is currently enrolled in “Professional Diploma in Business Planning and Strategy”, by Rochester Institute of Technology, USA.

Dina holds a Bachelor of Pharmacy – Faculty of Pharmacy – Cairo university , MBA Maastricht school University-The Netherlands.<br>She have extensive knowledge and experience in Pharma industry and Health sector, regulatory affairs, governmental affairs for 23 years.

She also spent 10 years working with Ministry of Health in Egypt- Head of registration pharmaceutical, veterinary, Dental medical supply departments and moving to industry working with companies Sevier, MSD.<br>
As a government official, it allows to encounter, deal with lot of different HA, Ministries e.g. ministry of foreign affairs, associations across different countries in ME, Africa. She also was Heading regulatory operations in Egypt, Libya, Saudi Arabia, year 2015- MSD.<br>
In 2016 until date she is heading Gulf region Regulatory operations -MSD Gulf.

She is also the local Chair for the Regulatory Working group in Gulf Region and an active member in Regulatory working group for Pharma Middle East and Africa.

Qutaiba Al Manaseer, is a Public affairs professional drawing on more than 15 years’ experience in the biopharmaceutical industry. He is the Government Affairs Director for the Middle East and Africa, and he is leading the COVID vaccine supply project in AstraZeneca in this region.

Qutaiba serves in the Emirates Health Economics Society board as the Media and Public Relations Chairman.

Qutaiba holds an MBA from the Swiss Business School, Switzerland and a bachelor’s degree in Pharmacy from the University of Jordan. He is completing a master’s in health economics from Barcelona School of Management.

Before joining AZ, Qutaiba was the strategic market access and pricing lead for GSK Gulf.

Qutaiba is a strong advocate for Diversity and Inclusion, and he was the Global Development Lead in the Executive committee of the Women Leadership Initiative in GSK.

Frank Dickert started with an apprenticeship in the pharmaceutical industry and afterwards studied biochemistry with a focus on bioinformatics and structural biochemistry. In 2011 he took an opportunity as a Regulatory Affairs Specialist at a pharmaceutical company and was responsible for centralized, DCP/MRP and national procedures.

In 2017 Frank joined EXTEDO’s Regulatory Competence Center and since then, he is consulting pharmaceutical companies in regulatory business and eCTD submissions worldwide. Furthermore, he is analyzing and optimizing regulatory business processes and document lifecycles with or without software, resolving customer support issues with different eSubmission tools, and offers regulatory consulting with regards to the respective tool.

Sylvie Meillerais started her career in research, in academia and industry, and moved to regulatory policy through positions in Brussels pharmaceutical trade associations, including EFPIA. She then joined MSD as Director Global Regulatory Policy in June 2015; in her current role, her expertise and knowledge of the European pharmaceutical environment serves to drive regulatory policy activities in the areas of CMC and Quality in the EU and globally. She is an active member of the EFPIA Manufacturing and Quality Experts Group and of the Middle East network, where she leads the Life Cycle Management efforts. She is further engaged in IFPMA CMC &amp; Quality policy activities.

Sylvie is a French national and graduated from the University of Bordeaux II with a Maîtrise in Biochemistry and Microbiology in 1993, completed by a Diploma from the University of Kent at Canterbury in the UK (Erasmus programme).

Sylvie can be followed on <a href=”https://www.linkedin.com/” tabindex=”-1″>linkedin</a>

Experienced, dynamic highly successful Regional Head of Market Access and Pricing, with proven ability to develop and execute strategic Market Access plans across wide portfolio of pharmaceutical brands at different stages of product life cycle. Solid expertise in the use of Health Economics in securing Reimbursement and Patient Access to therapy. Demonstrated significant success with major multi-national organizations over the last 13 years; engaging external stakeholders, building KOL networks and shaping Healthcare Policies. Outstanding leadership competencies in managing regional teams, highlighted with strategic thinking, strong analytical and planning skills, combined with the ability to coordinate efforts and influencing cross-functional teams to meet organizational goals.

<strong>Overview</strong>
Regulatory Affairs expert with a demonstrated history of working in the Pharmaceutical industry. Played different roles in Middle East region strongly focusing on pharma, consumer health, OTC, nutrition &amp; medical devices. Leading teams in cross-functional projects directly impacting expansion and access of new innovative medicines. Lead task forces in Pharma associations opening dialogue with MOH enforcing regulations. Speaker in Pharma-industry conferences.</p>
<strong>Areas of expertise</strong>
Extensive experience in portfolio management of&nbsp; different classifications such as OTC &amp; Prescription medicine, Medical devices, Nutrition and cosmetics, and Biological products. Leading as a business partner to identify future trends and tailoring best regulatory solutions. Liaise with supply team to secure stocks and pre-solve coming challenges.
<strong>Experience</strong>
Bring 15 years’ experience in pharmaceutical industry in national and multinational Companies in Egypt and extended to middle east including Sanofi and Bayer. Joined IQVIA as associate director Global Regulatory Affairs.</p>

<strong>Education</strong>
Bachelor’s degree in Pharmaceutical science from Cairo university in Egypt,2005.
Diploma in Marketing from the American university in Cairo, 2010.

Sattam Turky Alghodyyr began his career as a pharmacist at King Khalid Hospital, AlMajma’ah, but soon moved to the Saudi Food &amp; Drug Authority gaining unparalleled experience in the Bioequivalence, while also establishing himself as an expert in Pharmacovigilance.

In 2016 he started at Saudi Pharmaceutical Industries and Medical Appliances Corporation- SPIMACO as the Pharmacovigilance and Bioequivalence Manager where he is now Director of Regulatory Affairs.

Sattam is the Founding Member of the Pharmaceutical Industry Association PIA, Member of the Board of Directors ARAC Healthcare Oct 2018 and a Committee member representing SPIMACO on the National Committee for Pharmaceutical Industries NCPI.

<strong>Dr.Nasser Alqahtani</strong> works for the first Central Health Cluster – Ministry Of Health (MOH) as an executive director for drug and pharmaceutical affairs and acting executive director for population health management directorate.

He is one of the Alfaisal University’s faculty members and works as an adjunct assistant professor of pharmacoepidemiology and Pharmacoeconomics.

He used to serve as a director for drug safety and risk management dept at Saudi Food and Drug Authority (SFDA) for 13 consecutive years.

He receives his B.S. in Pharmacy from King Saud University, M.Sc. in clinical pharmacy from the UCL – UK and Ph.D. in pharmaceutical policy and outcomes research (Major: Pharmacoepidemiology) from Auburn University – Alabama, USA. He holds a certificate of higher diploma in pharmacovigilance and pharmacoepidemiology from London School of Hygiene and Tropical Medicine (LSHTM).

He is a member of a couple of professional societies: the International Society for Pharmacoepidemiology (ISPE), International Society of Pharmacovigilance (ISOP) International Society of pharmacoeconomics and outcomes research (ISPOR) American Association of Pharmaceutical Scientists (AAPS). Besides, he is a chairman of the national evidence-based practice committee at Saudi Health Council (SHC).

Baha AbuSalem is the Program Director of Tatmeen at EVOTEQ. Tameen, an initiative of the Ministry of Health and Prevention, is a highly advanced track and trace platform for pharmaceuticals and medical products based on EVOTEQ’s SmartTrack solution. This program will ensure the protection of public health and improve the security of healthcare at all stages.

A seasoned IT executive, AbuSalem has led large-scale projects in several verticals including government, telecommunications, transportation, and logistics. He has been driving innovation and delivering value-added experiences to companies through new and relevant technologies. AbuSalem holds an MBA from the University of Strathclyde, UK.

I hold a PhD in Biochemistry from Imperial College, London and have over 25 years of experience working with biological products in bio-pharmaceutical (CELLTRION, POLUS, ABBVIE), consultancy (PAREXEL), regulatory (MHRA), manufacturing (PROMETIC BIOSCIENCES, LONZA) and academic (ROYAL POSTGRADUATE MEDICAL SCHOOL, IMPERIAL COLLEGE) environments.

In my current role at CELLTRION, I have responsibility for the global regulatory strategy to support our extensive (more than 20) biosimilar monoclonal antibody pipeline.&nbsp; I am presently a member of the Medicines for Europe Biosimilars Sector Group.</p>
At POLUS, I was responsible for the development of an extensive microbial derived biosimilar pipeline with oversight of over 60 scientists and professionals across R&amp;D and regulatory affairs.
<p>At ABBVIE, I was initially part of the Biologic Strategic Development Group, a global team who informed on biosimilar policy and development activities before moving into a European Regulatory Policy and Intelligence role for a variety of other policy areas.&nbsp; Whilst at ABBVIE, I was Chair of IFPMA BioT Working Group and a member of EUROPABIO and EFPIA working groups.

At PAREXEL, I was the European Practice lead for all Regulatory/CMC issues related to biological products, especially biosimilars and predominantly worked with CELLTRION supporting their biosimilar pipeline and the approval of the first monoclonal antibody biosimilar (infliximab, REMSIMA^TM), in Europe.

At the MHRA, I was a Senior Quality Assessor in the Biologicals Unit reviewing CMC data for all types of biological products and was a Regular contributor to both UK and CHMP scientific advices as well as being a member of various CHMP guideline groups and working parties.

At PROMETIC BIOSCIENCES, I coordinated all Bioprocessing/Technical Support activities relating to affinity chromatography adsorbent development.

At LONZA, my role was a Senior Purification Scientist developing downstream purification processes for monoclonal antibodies for multiple clients and supporting transfer from bench to commercial scale.

Wesal holds a Bachelor of Science in Pharmacy from the University of Jordan, MSc.in Pharmaceutical Sciences from the Applied Science Private University, has completed a professional Diploma in Supply Chain Management. Assigned as Director General Technical Assistant / Jordan Food & Drug Administration in Jan 2021 , and as Drug directorate director from July 2017 until Jan 2021, assigned as Chairman and Vice-Chairman of several committees at JFDA ,She worked as head of drug registration department in the period 2012-2017, through her participation as a member in the Technical Committees, she contributed to the development and establishment of regulations and instructions for drug registration and review process, she was a member in faculty of pharmacy council in several universities in Jordan , she participates regularly in regional and international workshops and conferences (as speaker and trainer).

Overview

Regulatory Affairs expert with a demonstrated history of working in the Pharmaceutical industry. Played different roles in Middle East region strongly focusing on pharma, consumer health, OTC, nutrition & medical devices. Leading teams in cross-functional projects directly impacting expansion and access of new innovative medicines. Lead task forces in Pharma associations opening dialogue with MOH enforcing regulations. Speaker in Pharma-industry conferences.

Areas of expertise

Extensive experience in portfolio management of different classifications such as OTC & Prescription medicine, Medical devices, Nutrition and cosmetics, and Biological products. Leading as a business partner to identify future trends and tailoring best regulatory solutions. Liaise with supply team to secure stocks and pre-solve coming challenges.

Experience

Bring 15 years’ experience in pharmaceutical industry in national and multinational Companies in Egypt and extended to middle east including Sanofi and Bayer. Joined IQVIA as associate director Global Regulatory Affairs.

Education

Bachelor’s degree in Pharmaceutical science from Cairo university in Egypt,2005.
Diploma in Marketing from the American university in Cairo, 2010.

Sattam Turky Alghodyyr began his career as a pharmacist at King Khalid Hospital, AlMajma’ah, but soon moved to the Saudi Food & Drug Authority gaining unparalleled experience in the Bioequivalence, while also establishing himself as an expert in Pharmacovigilance.

In 2016 he started at Saudi Pharmaceutical Industries and Medical Appliances Corporation- SPIMACO as the Pharmacovigilance and Bioequivalence Manager where he is now Director of Regulatory Affairs.

Sattam is the Founding Member of the Pharmaceutical Industry Association PIA, Member of the Board of Directors ARAC Healthcare Oct 2018 and a Committee member representing SPIMACO on the National Committee for Pharmaceutical Industries NCPI.

Dr.Nasser Alqahtani works for the first Central Health Cluster – Ministry Of Health (MOH) as an executive director for drug and pharmaceutical affairs and acting executive director for population health management directorate.

He is one of the Alfaisal University’s faculty members and works as an adjunct assistant professor of pharmacoepidemiology and Pharmacoeconomics

He used to serve as a director for drug safety and risk management dept at Saudi Food and Drug Authority (SFDA) for 13 consecutive years.

He receives his B.S. in Pharmacy from King Saud University, M.Sc. in clinical pharmacy from the UCL – UK and Ph.D. in pharmaceutical policy and outcomes research (Major: Pharmacoepidemiology) from Auburn University – Alabama, USA. He holds a certificate of higher diploma in pharmacovigilance and pharmacoepidemiology from London School of Hygiene and Tropical Medicine (LSHTM).

He is a member of a couple of professional societies: the International Society for Pharmacoepidemiology (ISPE), International Society of Pharmacovigilance (ISOP) International Society of pharmacoeconomics and outcomes research (ISPOR) American Association of Pharmaceutical Scientists (AAPS). Besides, he is a chairman of the national evidence-based practice committee at Saudi Health Council (SHC)

Baha AbuSalem is the Program Director of Tatmeen at EVOTEQ. Tameen, an initiative of the Ministry of Health and Prevention, is a highly advanced track and trace platform for pharmaceuticals and medical products based on EVOTEQ’s SmartTrack solution. This program will ensure the protection of public health and improve the security of healthcare at all stages.

A seasoned IT executive, AbuSalem has led large-scale projects in several verticals including government, telecommunications, transportation, and logistics. He has been driving innovation and delivering value-added experiences to companies through new and relevant technologies. AbuSalem holds an MBA from the University of Strathclyde, UK.

I hold a PhD in Biochemistry from Imperial College, London and have over 25 years of experience working with biological products in bio-pharmaceutical (CELLTRION, POLUS, ABBVIE), consultancy (PAREXEL), regulatory (MHRA), manufacturing (PROMETIC BIOSCIENCES, LONZA) and academic (ROYAL POSTGRADUATE MEDICAL SCHOOL, IMPERIAL COLLEGE) environments.

In my current role at CELLTRION, I have responsibility for the global regulatory strategy to support our extensive (more than 20) biosimilar monoclonal antibody pipeline. I am presently a member of the Medicines for Europe Biosimilars Sector Group.

At POLUS, I was responsible for the development of an extensive microbial derived biosimilar pipeline with oversight of over 60 scientists and professionals across R&D and regulatory affairs.

At ABBVIE, I was initially part of the Biologic Strategic Development Group, a global team who informed on biosimilar policy and development activities before moving into a European Regulatory Policy and Intelligence role for a variety of other policy areas. Whilst at ABBVIE, I was Chair of IFPMA BioT Working Group and a member of EUROPABIO and EFPIA working groups.

At PAREXEL, I was the European Practice lead for all Regulatory/CMC issues related to biological products, especially biosimilars and predominantly worked with CELLTRION supporting their biosimilar pipeline and the approval of the first monoclonal antibody biosimilar (infliximab, REMSIMA ^TM ), in Europe.

At the MHRA, I was a Senior Quality Assessor in the Biologicals Unit reviewing CMC data for all types of biological products and was a Regular contributor to both UK and CHMP scientific advices as well as being a member of various CHMP guideline groups and working parties.

At PROMETIC BIOSCIENCES, I coordinated all Bioprocessing/Technical Support activities relating to affinity chromatography adsorbent development.

At LONZA, my role was a Senior Purification Scientist developing downstream purification processes for monoclonal antibodies for multiple clients and supporting transfer from bench to commercial scale.

Wesal holds a Bachelor of Science in Pharmacy from the University of Jordan, MSc.in Pharmaceutical Sciences from the Applied Science Private University, has completed a professional Diploma in Supply Chain Management. Assigned as Director General Technical Assistant / Jordan Food & Drug Administration in Jan 2021 , and as Drug directorate director from July 2017 until Jan 2021, assigned as Chairman and Vice-Chairman of several committees at JFDA ,She worked as head of drug registration department in the period 2012-2017, through her participation as a member in the Technical Committees, she contributed to the development and establishment of regulations and instructions for drug registration and review process, she was a member in faculty of pharmacy council in several universities in Jordan , she participates regularly in regional and international workshops and conferences (as speaker and trainer).

Dr Mariam Al-Jalahma was appointed by His majesty the King of Bahrain, in 2015 as the Chief Executive Officer of the National Health Regularity Authority in the Kingdom of Bahrain. She is as a member of the supreme council of health in Bahrain, and is appointed by the prime minister as a member in Academic accreditation Committee of the supreme council for Higher education in 2016.
Previous positions:

She was holding the position of Assistant Undersecretary for Primary Care and Public Health until 2015, and was a member of the Executive Board of The Health Ministers’ Council for GCC States until 2016.
A member of the Sura Council in 2000, and a member of the National Institute for Human rights. Dr. Al-Jalahma worked as an advisor for the world health organization in the fields of Adolescents and Non communicable diseases (NCDs).
Qualifications:· Arab Board certificate in Family & Community Medicine in 1990
· Higher studies diploma in medical education from Dundee University in Scotland in 1994
· Diploma in Health Care Management from Royal college of surgeon in Ireland in 2000
Honorees & medals
· In December 2011 she was awarded an honouree medal of efficiency by his majesty the king of Bahrain.
· In 1990 Awarded by the prime minister awards for leaders of Moharraq.
· In 2009 she was awarded by Her Highness Shaikha Sabika Bent Ebrahim Al-Khalifa the Princess of Bahrain and Chairperson of Woman Supreme council the award of National Woman day Celebration, the award is presented to women leaders in health.
· In June 2011 she is awarded by the regional office for eastern Mediterranean of the WHO the Anti-tobacco award of the region.
· Global award for health pioneers from UAE
· GCC leaders Award 2019