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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
General Manager, Biological and Innovative Products and Clinical Studies
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)
The Importance of International Collaboration for Fostering Harmonization and Convergence
Sondos Moshtohry
Egyptian Drug Authority (EDA), Egypt
Manager of the Administration for Cooperation with International Organizations
Regional Harmonisation Initiatives: The North African Medicines Reguatory Harmonisation (NA-MRH) Initiative -Challenges & Opportunities
Dalia Abou Hussein
Egyptian Drug Authority (EDA), Egypt
QA General Manager
Asmaa Fouad
Egyptian Drug Authority , Egypt
General Manager, Biological and Innovative Products and Clinical Studies
International: ICH and IPRP - Updates from the last Assembly & Experiences of the Path from ICH Observer to Member
Asmaa Fouad
Egyptian Drug Authority , Egypt
General Manager, Biological and Innovative Products and Clinical Studies
International: ICH and IPRP - Updates from the last Assembly & Experiences of the Path from ICH Observer to Member
Neil McAuslane, PhD, MSc
Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Director
International: ICH and IPRP - Updates from the last Assembly & Experiences of the Path from ICH Observer to Member
Rana Malkawi
Jordan Food and Drug Administration (JFDA), Jordan
Drug Directorate Director
Panel Discussion with QandA, with the additional participation of:
Sarah Ibrahim, PharmD, PhD
FDA, United States
Associate Director for Stakeholder and Global Engagement, Office of Generic Drug
Panel Discussion with QandA, with the additional participation of:
Victoria Palmi-Reig
European Medicines Agency, Netherlands
International Affairs
Panel Discussion with QandA, with the additional participation of:
Mariem Kadri
Directorate of Pharmacy and Medicine, Tunisia
Pharmacist assessor
Panel Discussion with QandA, with the additional participation of:
Donia Al Bastaki
Ministry of Health, Drug and Food Control, Kuwait
Head of Registration Department, Pharmaceutical & Herbal Medicines Registration
Panel Discussion with QandA, with the additional participation of:
Heba Nabil
Pfizer, Egypt
Regulatory Affairs Senior Manager
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