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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)
EFPIA LCM paper – what progress has been made?
Susanne Ausborn, PhD
Roche, Switzerland
Global Head International Regulatory Policy
Q&A and Panel Discussion, with the participation of:
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
Sabah Memon
National Health Regulatory Authority (NHRA), Bahrain
Senior Pharmacist
Shereen Abdel-Gaward
Egyptian Ministry of Health and Population, Egypt
Head of Central Administration of Pharmaceutical Care
Maha Al Jaghbeer
Jordan Food and Drug Administration, Jordan
Pharmacist, Head of Drug Registration Department
Bandar Al Hammad, MPharm
Saudi Food and Drug Authority (SFDA), Saudi Arabia
Chief Pharmacist, Regulatory Affairs Department
Industry reflection on challenges with safety updates in the region
Catherine Al Ashram
Organon, Jordan
VP Regulatory Affairs & PV, Latin America MEA and Russia
Q&A and Panel Discussion, with the participation of:
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
Christina Saad Khalil
Egyptian Pharmaceutical Vigilance Center, Egypt
Pharmacovigilance Committee Rapporteur
Sarah Al Maqseed
Ministry of Health, Kuwait, Kuwait
Registration and Release Superintendent
Sylvie Meillerais, MSc
Institut De Recherches Internationales Servier, France
Head of CMC Excellence
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