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Session 2: Regulatory Reliance
Session Chair(s)
Amira Younes
Director- Europe, Middle East & Africa (EMEA), 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
Team Lead, Facilitated Product Introduction, WHO, Switzerland
EMA Supportive Program to Facilitate Regulatory Convergence & Reliance
Victoria Palmi-Reig, MPharm
International Affairs, European Medicines Agency, Netherlands
EMA Focus Group and Other Activities
Andrew Deavin, PhD, MS
Senior Director, Regulatory Affairs, GSK, Belgium
PAC Reliance Case Study with 48 NRAs Participation
Francesca Mangia, PhD
Regulatory Affairs International Operations Manager, F. Hoffmann-La Roche Ltd, Switzerland
Reliance and Streamlining of Post-Approval Changes
Fotios Baxevanis
Senior Regulatory Affairs Specialist, International CMC EU/EMEA, MSD, United Kingdom
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