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Session 1, Part 1: Good Regulatory Practice and Optimised Registration Pathways
Session Chair(s)
Paul Dearden
Senior Director, 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)
Update on Global Developments Regarding Good Regulatory Practices and Collaborative Procedures
Stuart Russel Walker, PhD
Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Professor and Consultant
Industry Perspective on Reliance & Expedited Pathways in Emerging Markets
Inas Chehimi
Novartis Pharma Services AG, United Arab Emirates
Head RA Middle East & North Africa
Abridged Processes in Saudi Arabia
Bandar Al Hammad, MPharm
Saudi Food and Drug Authority (SFDA), Saudi Arabia
Chief Pharmacist, Regulatory Affairs Department
Good Practice Sharing in Egypt
Yasin Afify
Egyptian Drug Authority, Egypt
Head of Technical Office, Central Administration for Pharmaceutical Affairs,
Ghadeer Al-Sheikh Salem
Jordan Food and Drug Administration, Jordan
Head, Originator and Biological Drugs Division, Registration Department
Gulf Health Council Central Registration - a new Beginning
Hajed M.H Hashan
Gulf Health Council, Saudi Arabia
Deputy of General Director
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