Speakers
Mark Abdoo
Associate Commissioner for Global Policy and Strategy, FDA, United States
Mr. Abdoo is Associate Commissioner for Global Policy and Strategy, providing executive oversight, strategic leadership and policy direction to global policy, operations, trade, and diplomacy activities. He joined FDA in 2013 as the inaugural director of the Office of Public Health and Trade. In 2015 he became Associate Commissioner for Regulatory Policy and in 2017 became Deputy Commissioner for Global Regulatory Operations and Policy (acting).
Abdulrahim Alyahya
Director, Biogen, Saudi Arabia
Zainab Aziz, MSc, RPh
Associate Director- Regulatory Policy MEA, Novartis, South Africa
Zainab is a pharmacist with an MSc in Medicine (Pharmaceutical Affairs) from the University of the Witwatersrand and over 15 years of regulatory affairs experience. She is currently Associate Director, Global Regulatory Affairs Policy at Novartis, supporting regulatory policy across the Middle East and Africa. She co-chairs the IFPMA Africa Regulatory Network and is a member of the EFPIA Middle East Regulatory Network. Zainab has led key initiatives in regulatory harmonisation, clinical trial oversight, capability building, and digital transformation, and actively supports the Africa Medicines Agency Treaty Alliance.
Delese Mimi Darko, MBA, RAC
Director General, African Medicines Agency (AMA) , Rwanda
Dr. Mimi Darko graduated as a pharmacist with an MBA. Her career in food and health products regulation spans over 30 years. Prior to her appointment as AMA's first DG, she rose through the ranks of the FDA to become its first female CEO in 2017. She led FDA’s designation as a Regional Center of Regulatory Excellence in Medicines Safety, Clinical Trials and Drug Registration. She contributed to the growth of research and of the local manufacturing industries in Ghana Mimi Chairs the Steering Committee of WHO African Vaccines Regulatory Forum and serves on several international and local expert committees. She has received several awards for her exemplary work. She is a devout Christian and married with two children.
Ali El-Ghamrawy
Chairman, Egyptian Drug Authority, Egypt
Asmaa Fouad
Head Central Adm. of Biological, Innov. Products & Clinical Trials, Egyptian Drug Authority, Egypt
Ms. Asmaa Fouad Ismail is currently General Manager of the Biological Products General Administration, the Central Administration of Biological and Innovative Products and Clinical Trials at EDA managing marketing authorization, lot release and laboratory evaluation, and analysis of biological products. Ms. Fouad is also delegate of EDA in ICH & IPRP since December,2021. She is also a member of the Emergency Committee at EDA and has participated in the formulation of many national guidelines in Egypt. She worked in the COVID-19 Vaccines Global Review team with the WHO. She has 20 years of biological products regulatory experience.
Amel Ghouila
Senior Program Officer, Gates Foundation, United States
Martin Harvey Allchurch, LLM
Head of International Affairs, European Medicines Agency, Netherlands
Martin Harvey is Head of International Affairs at the European Medicines Agency (EMA), EU. He first joined the EMA legal team after serving as a European affairs consultant in Brussels. He headed the Office of the Executive Director, served as Head of Communication, and then moved to the Agency's International Affairs team. He took an 18-month career break with Unitaid, the WHO-hosted partnership dedicated to innovation in global health from 2019-2020. Martin has served on the DIA Advisory Council for EMEA; and as program advisor for DIA's EuroMeeting and Global Annual Meeting. He holds law degrees from the University of Dundee (UK) and the Vrije Universiteit Brussels (Belgium). He is a Fellow of DIA since 2018.
Osama Hatem
EDA Chairman Associate for Policies & International Cooperation and Supervisor o, EDA, Egypt
Sarah Ibrahim, PharmD, PhD
Deputy Center Director for Regulatory Programs - (CDER), U.S. Food and Drug Administration (FDA), United States
Sarah Ibrahim is the Associate Director for Stakeholder and Global Engagement in the OGD/ CDER at the U.S. Food and Drug Administration (FDA). Dr. Ibrahim develops OGD strategies to address identified and emerging regulatory challenges in relation to the international nature of the generic drug industry. She established OGD’s current global affairs program, the generic drug cluster which is the first generic drug forum that involves the word leading regulatory agencies. In collaboration with other CDER and FDA offices, she supports stakeholder engagement concerning issues related to globalization of the generic pharmaceutical supply and harmonization of regulatory approaches for generic drugs.
Kwaku Marfo, PharmD, MBA, MPH
Africa Market Development Specialist, IQVIA, Ghana
Kwaku Marfo currently holds a role of Market Development Specialist for sub-Sahara Africa with IQVIA. Kwaku is a dynamic Life Sciences leader with 18 years of experience in Pharma and Global Health across US, Europe and Africa markets in diverse therapeutic areas such as Hematology, Rare Disease, Dermatology, Immunology & Rheumatology. Prior to IQVIA, Kwaku spent 11 years at Novartis Pharmaceutical Corporation in both their US and Global Headquarters in New Jersey and Switzerland, respectively. Kwaku recently completed Harvard Medical Executive Program for Senior Life Science Leaders. His educational background includes a Doctor of Pharmacy (PharmD.), Master of Business Administration (MBA), and master's in public health (MPH).
David Mukanga, PhD, MPH
Deputy Director, Africa Regulatory Systems, Gates Foundation, United States
Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports the development of harmonized, transparent, and predictable regulatory systems covering the lifecycle of medical products in Africa across the national, regional, and continental levels of the ecosystem. His work also involves support for regulatory emergency preparedness. In this role he works side by side with partners on the African continent to facilitate development of new medical products, as well as patient access to quality essential medicines.
John Mwangi
Regulatory Policy Lead, Bayer, Kenya
Amira Deia Younes
Director- Europe, Middle East & Africa (EMEA), Science & Regulatory Policy, MSD, United Arab Emirates
Amira is Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years’ experience in regulatory science and policy. A recognized thought leader in regulatory reliance, work sharing, and harmonization, she builds cross-sector networks to strengthen regulatory practices across the region. She chairs the EFPIA Middle East Regulatory Network and is active in trade associations and forums including the EMA Reliance focus group, EFPIA, IFPMA (notably IFPMA Reliance network and IFPMA Africa Regulatory Network ), and PhRMA. A frequent conference speaker and session leader with multiple publications, she holds a bachelor’s degree in pharmacy and biotechnology from the German University in Cairo.
Paul Chilwesa
Head of Policy, Population Health & Health Systems Strengthening, Africa, Roche Pharma, Switzerland
Tamei Elliott, MS
Director, Global Scientific Content, DIA, United States
Tamei Elliott, MS, is the Director of Global Scientific Content at the Drug Information Association (DIA). She leads DIA’s global scientific content strategy, ensuring alignment with regulatory priorities, industry trends, and evolving stakeholder needs across regions. She also established and leads DIA’s Global Science Content Center of Excellence, driving harmonization of content development and strategy across Europe, Asia, North Africa, and the Middle East. With expertise in regulatory science, she brings stakeholders together to address the life sciences industry’s most pressing challenges, driving outcomes that move toward solutions.
Elizabeth C. Smith
Deputy Director, Regulatory Affairs, Gates Foundation, United States
Christopher Colwell, MPA
Vice President, International Government and Regulatory Affairs, US Pharmacopeia, United States
Chris Colwell is Vice President, International Government & Regulatory Affairs at the United States Pharmacopeia (USP). He leads a team that develops USP’s position on public policy and regulatory affairs issues related to its mission to improve global health through public standards.Chris’ prior experiences span technical and policy work across pharmaceuticals and medical devices in government, private sector and NGO sectors. He has worked at the US FDA, Merck & Co., Inc (known as MSD outside of the U.S. and Canada), Becton Dickinson (BD) and the Biotechnology Innovation Organization (BIO). Chris received his Masters in Public Policy from Georgetown University and a B.S. in Chemical Engineering from the Pennsylvania State University.
Aastha Gupta
Director of Market Access, , TB Alliance, Switzerland
Christopher Obwanga
Sr. Director, Clinical Operations, Africa, IQVIA, Kenya
Charlie Preston
Senior Program Officer, Regulatory Affairs, Gates Foundation, Gates Foundation, United States
Stuart Walker, PhD
Consultant in Pharmaceutical Medicine, Professor of Regulatory Science, University of Hertfordshire and University of Witwatersrand, United Kingdom
Professor Stuart Walker, BSC, PhD (London), MFPM, FRSC, FiBiol, FRCPath, is an independent Consultant in Pharmaceutical Medicine and Founder of both the Centre for Medicines Research (CMR) International and the Centre for Innovation in Regulatory Science (CIRS). UK
Marwan Fathallah, MBA, MSc
DIA CEO, DIA, United States
Prior to joining DIA in 2023, Fathallah was the Operating Officer and EVP at Ortho Clinical Diagnostics, accountable for Operations, Post Market Product Science and Engineering, Regulatory, Quality, Medical, Clinical, Scientific Affairs, and Process Excellence. Before joining Ortho, he held Executive and Senior Leadership roles in Research and Development, Operations, and Regulatory Medical and Clinical Affairs at Avantor, Danaher, Pfizer, Hospira, and Abbott Laboratories. Fathallah holds a Master’s and Bachelor of Science degrees in Mechanical Engineering from the Univ. of Wisconsin-Madison and an MBA from the Kellogg School of Management at Northwestern University.
Daniel Hartman, MD
Director, Integrated Development, Gates Foundation, United Kingdom
Victoria Palmi-Reig, MPharm
International Affairs, European Medicines Agency, Netherlands
Victoria Palmi, Senior International Affairs officer, has over 20 years of experience at the European Medicines Agency (EMA). She supports international collaboration programs and reliance as part of her role in the International Affairs office. Previously, Victoria worked as Product Lead in different therapeutic areas within the Evaluation of Medicines department. During this time, she led initiatives that accelerated assessment and early access to priority medications.
Naim Hage
Cluster Head for East & West Africa, IQVIA , IQVIA , Ghana
Samvel Azatyan, MD
Deputy Secretary-General, Council For International Organizations of Medical Sciences (CIOMS), Switzerland
Dr Samvel Azatyan is a paediatrician with a PhD in clinical pharmacology and medical products regulation and more than 35 years of experience in global health. During 26 years with the World Health Organization, he held senior leadership roles in medical products regulation, including regulatory systems strengthening, collaboration, convergence and harmonization, capacity building, product introduction and regulatory reliance. He also played a leading role in organizing the International Conferences of Drug Regulatory Authorities (ICDRAs) and supported national, regional and global regulatory initiatives. Dr Azatyan is currently Deputy Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS) in Geneva.
Michael Davis, MD, PhD
Acting Center Director, Center for Drug Evaluation and Research (CDER), FDA, United States
Aissatou SOUGOU, PharmD, MPA, MPH, MSc
Director General, Agence sénégalaise de Réglementation Pharmaceutique (ARP), Senegal
Dr Aissatou Sarassa Sougou is the Director General of the Agence Sénégalaise de Réglementation Pharmaceutique (ARP Senegal). She is a pharmacist and public health specialist with more than 15 years of experience in pharmaceutical regulation, access to medicines, health systems strengthening, and regional health policy across Africa. Prior to her appointment as Director General, she served as Senior Pharmaceutical Technical Adviser at the World Health Organization Regional Office for Africa, where she led regional initiatives on essential medicines, diagnostics, medical devices, and supply chain systems across 47 Member States. Dr Sougou has extensive expertise in regulatory systems strengthening, market shaping, pharmaceutical produc
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