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Session 1, Part 1: Good Regulatory Practice and Optimised Registration Pathways
Session Chair(s)
Paul Dearden
Head, Global Regulatory Policy, Biogen, United Kingdom
Patients are demanding faster access to new medicines, especially in areas of high unmet medical need, ineffective and inefficient regulatory systems can be a barrier to access to safe, quality medical products. This session focuses on the key principles in regulatory systems (good regulatory practices) to provide sufficient flexibility to enable innovation and ensure agencies’ resources are efficiently utilised. Speakers will describe related international guidances and regulators will share their experiences implementing good regulatory practices and optimised registration procedures. Finally, interactive panel discussions will address the question “can we do more to improve systems and align with these principles?”
Speaker(s)
Stuart Russel Walker, PHD
Professor and Consultant, Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Update on Global Developments Regarding Good Regulatory Practices and Collaborative Procedures
Inas Chehimi
Head Regulatory Affairs - Middle East & North Africa, Novartis Pharma Services AG, United Arab Emirates
Industry Perspective on Reliance & Expedited Pathways in Emerging Markets
Bandar Al Hammad, MPHARM
Chief Pharmacist & Director of Veterinary Products Department, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Abridged Processes in Saudi Arabia
Yasin Afify
Head of Technical Office, Central Administration for Pharmaceutical Affairs, , Egyptian Drug Authority, Egypt
Good Practice Sharing in Egypt
Ghadeer Al-Sheikh Salem
Head, Originator and Biological Drugs Division, Registration Department, Jordan Food and Drug Administration, Jordan
Hajed M.H Hashan
Deputy of General Director, Gulf Health Council, Saudi Arabia
Gulf Health Council Central Registration - a new Beginning
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