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How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance
Session Chair(s)
Max Wegner, PharmD, RPh
Head Regulatory Affairs
Bayer AG, Germany
This session will highlight the complexity of regulatory frameworks for PACs drawing from an IFPMA/Clarivate study and case studies. An expert panel from industry and regulatory agencies will discuss solutions and lessons learned on reliance implementation.
Learning Objective : Explain the different regulatory frameworks for PACs compared to WHO and EMA; Identify lessions learned from reliance implementation for PACs to facilitate supply of medicinal products.
Speaker(s)
Panelist
Evdokia Korakianiti, PhD, MSc
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
Panelist
Marie Valentin, PharmD
WHO, Switzerland
Team Lead, Facilitated Product Introduction
Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management (PQKM) Capability
Theresa Mullin, PhD
FDA, United States
Associate Center Director - CDER
Bringing Reliance into Action - Our Journey From Pilots to Practice
Susanne Ausborn, PhD
Roche, Switzerland
Global Head International Regulatory Policy
Why is Regulatory Reliance a Necessity and not a Choice? An Illustration Using Industry Survey Results
Andrew Deavin, PhD, MS
GSK, Belgium
Senior Director, Regulatory Affairs
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