Dr. Hajed bin Hajed is a strategic and knowledgeable healthcare professional who is known for his efforts to strengthen the pharmaceutical and health industry’s ecosystem across the Gulf region.

He is a respected healthcare leader who is dedicated to improving healthcare delivery and outcomes in the Gulf region.

Lamia Mohamed Al-Ali a senior pharmacist working at the ministry of health and prevention in the drug department since 2013. With a bachelor degree in pharmacy from University of Sharjah on 2012, and a master degree in pharmaceutical science on Oct 2022.

Dr. Mahmoud is working in MOHAP, drug department since 2020, with a master’s degree in pharmaceutical analytical chemistry, he is a member in the technical committee at MOHAP, with 16 years of experience in the management and advisory on quality system for leading companies within pharmaceutical manufacturing field.

Before joining MOHAP, Mahmoud was quality control manager in Julphar, RAK and Adcan pharma, Abu Dhabi.

Dr. Mahmoud has many published researches in the USA AOAC journal about evaluation of pharmaceutical dosage forms in human biological fluids and stability studies.

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

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).

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

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.

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).

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.

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.

Bachelor’s degree in pharmacy/University of Jordan 

Regulatory affairs Global Certificate (RAC)USA

Hikma Pharmaceuticals (12 years)

• Regulatory Affairs Associate director, RA Due diligence, and Consultant for RA activities March 2022
• RA Senior Manager for North Africa region and Due diligence 2019-2022
• RA Senior Manager at Hikma Pharmaceuticals Due diligence for under licensed products since Feb 2012 – 2019
• RA Senior Manager of MENA July 2011-Feb 2012

JFDA (20 Years)

Head of registration department at Jordanian food and drug administration.

• Drafted many of JFDA regulatory guidelines as Bioequivalence, stability, CTD, Biosimilars, GMP and Tech transfer, value added medicine VAM.
• Head of bioequivalence assessment Committee 1997-2011
• Head of Vaccines and Sera, biological products committee 2008-2011
• Head of Cosmetic and Medical devices unit and head of the committee 1995-2005
• Head of GMP and Site accreditation 2001-2005
• Head of Renewal committee 2002-2004
• Pricing Department 1994-2003
• Narcotic Department 2004-2006

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

• Regulatory Affairs Professionals Society (RAPs),
• Canadian Association of Professionals in Regulatory Affairs (CAPRA)
• Arab Union of Pharmaceutical Manufacturers (AUPAM),
• Jordan Pharmaceutical Association (JPA)

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).

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.

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.

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.

The Pop in my Job:

«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».

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

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

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.

Global Strategic Compliance Quality Director with over 22 years of diversified Quality experiences in the scope of Technical Ops, Manufacturing, Commercial affiliates and Distribution within the Pharmaceutical and Medical Device industry including over 12 years in Quality leadership position within a multinational business culture.

His experience covers various type of operations, Sterile (liquid, lyophilized), non-sterile (solids, semi-solids and liquids) and Beta lactam/Cephalosporins including deployment of operational excellence utilizing practical knowledge and expertise to integrate lean manufacturing principles (kaizen tools) within a regulated environment delivering tangible results in process optimization, reducing product defect rate and achieving product cost avoidance.

Experience was acquired globally in North America, Middle East, Africa, and China. Mr. Mazen is a collaborative leadership team member and recognized change agent with critical thinking and problem solving as strengths which resulted in leading quality issue mitigation for sustained improvement and deploying the expected Quality culture. He has a track record for effective collaboration with cross-functional teams to attain and sustain robust and fit for purpose compliant operational QMS across different business processes and new acquisitions in accordance to USFDA, Health Canada and GCC regulations yielded outstanding inspection’s outcome.

Further, engaged in projects for new products launch, geo-expansion, technology transfer and Supply Chain projects transition to outsourcing operations in the USA and China effectively. Currently, he am a collaborative member of the global quality leadership team responsible for defining and enhancing the company’s Quality strategy map, strategic projects and monitoring programs.

Driving globally strategic Quality compliance concepts by partnering with cross functional teams to define tactical approaches, guidance and best practices to arm process owner for effective implementation of critical operational and quality processes such as Pharma 4.0, CPV/OPV, GxP data integrity, etc.

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.

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.

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).

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.

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.

Prior Shire Ebla was regulatory affairs in her home country (Syria) for over 7 years and her major achievements have been:

• 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

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.

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.

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.

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.

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.

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).

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.

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.

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).

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.

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.

He has more than 14 years’ experience in Regulatory Affairs field.

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

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.

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.

Dr. Yousra a Regulatory Affairs and Commercial & Distribution Quality Assurance Director, Strategic Project Lead with over 17 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 & 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 RA 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.

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.

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.

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. 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.

She exercises highly complex level of independent judgment and execution directly impacting the operational results of the business unit; manages overseas and balances resource allocation across critical projects; and is responsible for regulatory aspects of products lifecycle management.

Dr. Rawya maintains communication with global and regional/local regulatory agencies, and she ensures that company policies, procedures and practices are in compliance with regulatory requirements as well as assuring timely regulatory clearance for key product launches in all key markets and assesses the current state of the department (organizational structure, competencies and skills) and implements a strategic vision and tactical plans consistent with the organizational and RA strategic objectives