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.