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Session 2: Regulatory Reliance
Session Chair(s)
Amira Younes
Director, Eastern Europe, Middle East & Africa (EEMEA) Global Regulatory Policy
MSD, United Arab Emirates
As a 21st century regulatory tool, reliance pathway has been broadly implemented by many countries around the world to enable faster access of medicines to patients and increase efficiency. This session will provide global perspective on the trend of regulatory reliance which includes WHO’ s initiatives to support reliance implementation, EMA’s supportive initiatives to facilitate regulatory convergence & reliance, DIA Europe Reliance workshop summary and learning from recent industry reliance cases.
Speaker(s)
Advantage of Reliance
Marie Valentin, PharmD
WHO, Switzerland
Team Lead, Facilitated Product Introduction
EMA Supportive Program to Facilitate Regulatory Convergence & Reliance
Victoria Palmi-Reig
European Medicines Agency, Netherlands
International Affairs
EMA Focus Group and Other Activities
Andrew Deavin, PhD, MS
GSK, Belgium
Senior Director, Regulatory Affairs
PAC Reliance Case Study with 48 NRAs Participation
Francesca Mangia, PhD
F. Hoffmann-La Roche Ltd, Switzerland
Regulatory Affairs International Operations Manager
Reliance and Streamlining of Post-Approval Changes
Fotios Baxevanis
MSD, United Kingdom
Senior Regulatory Affairs Specialist, International CMC EU/EMEA
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