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Session 6: Convergence and reliance for post-approval changes - where do we stand today?
Session Chair(s)
Susanne Ausborn, PHD
Global Head International Regulatory Policy, Roche, Switzerland
This session will highlight the progress since the 2017 MERC and the publication of the EFPIA recommendations for ‘Optimising the management of Post-Approval Changes’, taking time to reflect on industry and Health Authority perspectives. Furthermore, the session will introduce the newly developed EFPIA position paper on managing post-approval safety labelling updates in the region with industry reflections on the challenges and opportunities that could be realised by global regulatory convergence and reliance.
Speaker(s)
Susanne Ausborn, PHD
Global Head International Regulatory Policy, Roche, Switzerland
EFPIA LCM paper – what progress has been made?
Samvel Azatyan, MD, PHD
Senior Adviser, Council For International Organizations of Medical Sciences (CIOMS), Switzerland
Q&A and Panel Discussion, with the participation of:
Sabah Memon
Senior Pharmacist, National Health Regulatory Authority (NHRA), Bahrain
Shereen Abdel-Gaward
Head of Central Administration of Pharmaceutical Care, Egyptian Ministry of Health and Population, Egypt
Maha Al Jaghbeer
Pharmacist, Head of Drug Registration Department, Jordan Food and Drug Administration, Jordan
Bandar Al Hammad, MPHARM
Chief Pharmacist & Director of Veterinary Products Department, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Catherine Al Ashram
VP Regulatory Affairs & PV, Latin America MEA and Russia, Organon, Jordan
Industry reflection on challenges with safety updates in the region
Samvel Azatyan, MD, PHD
Senior Adviser, Council For International Organizations of Medical Sciences (CIOMS), Switzerland
Q&A and Panel Discussion, with the participation of:
Christina Saad Khalil
Pharmacovigilance Committee Rapporteur, Egyptian Pharmaceutical Vigilance Center, Egypt
Sarah Al Maqseed
Registration and Release Superintendent, Ministry of Health, Kuwait, Kuwait
Sylvie Meillerais, MSC
Head of CMC Excellence, Institut De Recherches Internationales Servier, France
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