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How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance
Session Chair(s)
Lesbeth Caridad Rodriguez, MS
Director, Regulatory Affairs Policy and Science
Bayer, United States
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 : Provide an overview of different regulatory frameworks for PACs compared to WHO and share lessons learned from the use of reliance for PACs to facilitate supply of medicinal products.
Speaker(s)
Panelist
Representative Invited
European Medicines Agency, Netherlands
ICMRA Pilot, Assessment Summary Report
Representative Invited
FDA, United States
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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