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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 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 Objectives

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.

Chair

Lesbeth Caridad Rodriguez, MS

Speaker

ICMRA Pilot, Assessment Summary Report
Theresa Mullin, PhD

Bringing Reliance into Action - Our Journey From Pilots to Practice
Susanne Ausborn, PhD

Why is Regulatory Reliance a Necessity and not a Choice? An Illustration Using Industry Survey Results
Andrew Deavin, PhD, MS


Speakers
avatar for Susanne Ausborn

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland
Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
avatar for Andrew Deavin

Andrew Deavin

Senior Director, Regulatory Affairs, GSK, Belgium
Andrew Deavin has spent over 25 years in Regulatory Affairs, after having gained a M.Sc. and Ph.D. in Immunology and working in vaccine research. He has managed regulatory projects in development, registration and life-cycle primarily in vaccines but also in haematology/oncology... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
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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