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How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

This session will exemplify the complexity of regulatory frameworks for PACs based on an IFPMA/Clarivate study. An expert panel from industry and agencies will discuss potential solutions and lessons learnt on reliance implementation for PACs

Learning Objectives

Explain the different regulatory frameworks for PACs compared to WHO and EMA; Understand lessons learnt from reliance implementation for PACs to facilitate supply of medicinal products.

Chair

Lesbeth Caridad Rodriguez, MS

Speakers
LR

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez, Director, Regulator Policy and Science at Bayer, is a regulatory policy leader specializing in advanced therapies and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group, and currently... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

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