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Session 2: International Collaboration, Harmonisation & Convergence
Session Chair(s)
Dina Fathy, MPHARM, AHIP
Senior Director, Regulatory Affairs Middle East Subregional Lead, MSD UAE, United Arab Emirates
Asmaa Fouad
Head Central Adm. of Biological, Innov. Products & Clinical Trials, Egyptian Drug Authority, Egypt
This session will cover a range of pivotal topics that are shaping the future of healthcare in the MENA region. We will explore innovative initiatives that are driving change, discuss the impact and progress of regional harmonisation initiatives, and examine the practical application of the WHO benchmarking tool. The session will also provide a platform to discuss the opportunities and challenges that come with regional collaboration, offering insights into best practices and potential solutions. Additionally, we will share the latest updates from the ICH Assembly to keep you informed of the latest global healthcare regulatory developments.
Speaker(s)
Sondos Moshtohry
Manager of the Administration for Cooperation with International Organizations, Egyptian Drug Authority (EDA), Egypt
The Importance of International Collaboration for Fostering Harmonization and Convergence
Dalia Abou Hussein
Quality Assurance (QA) General Director, Egyptian Drug Authority (EDA), Egypt
Regional Harmonisation Initiatives: The North African Medicines Reguatory Harmonisation (NA-MRH) Initiative -Challenges & Opportunities
Asmaa Fouad
Head Central Adm. of Biological, Innov. Products & Clinical Trials, Egyptian Drug Authority, Egypt
Asmaa Fouad
Head Central Adm. of Biological, Innov. Products & Clinical Trials, Egyptian Drug Authority, Egypt
International: ICH and IPRP - Updates from the last Assembly & Experiences of the Path from ICH Observer to Member
Neil McAuslane, PHD, MSC
Scientific Director, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
International: ICH and IPRP - Updates from the last Assembly & Experiences of the Path from ICH Observer to Member
Rana Malkawi
Drug Directorate Director, Jordan Food and Drug Administration (JFDA), Jordan
International: ICH and IPRP - Updates from the last Assembly & Experiences of the Path from ICH Observer to Member
Sarah Ibrahim, PHARMD, PHD
Acting Deputy Center Director for Regulatory Programs, FDA, United States
Panel Discussion with QandA, with the additional participation of:
Victoria Palmi-Reig, MPHARM
International Affairs, European Medicines Agency, Netherlands
Panel Discussion with QandA, with the additional participation of:
Mariem Kadri
Pharmacist - Directorate of Pharmacy and Medicine , ANMPS (Agence Nationale Du Médicaments et des Produits de la santé), Tunisia
Panel Discussion with QandA, with the additional participation of:
Donia Al Bastaki
Head of Registration Department, Pharmaceutical & Herbal Medicines Registration , Ministry of Health, Drug and Food Control, Kuwait
Panel Discussion with QandA, with the additional participation of:
Heba Nabil
Chair-Egypt RWG EFPR & Regulatory Sciences Director- Egypt & Sudan, Pfizer, Egypt
Panel Discussion with QandA, with the additional participation of:
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