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Session 7: Lifecycle Management– How to Cope with the Increasing Regulatory Demand on Post-Approval Changes for Faster Medicines Access to Patients?
Session Chair(s)
Ana Padua, MSC, RPH
Director EU Global Regulatory and Scientific Policy , Merck Kgaa, Darmstadt, Germany (EMD Serono, US), Switzerland
The session will cover the most recent regulatory updates on post-approval changes for pharmaceutical products facilitating global regulatory convergence. It includes an overview of the recent WHO Post-Approval Changes guideline for biotech products, the experience of ANVISA as an ICH member and part of ICH Q12 Working Group, and the industry perspective in this context of evolving and very dynamic regulatory environment. To support innovative and accelerated drug development approaches, an efficient regulatory lifecycle management is key and should include regulatory processes based on reliance and worksharing.
Learning Objective : At the conclusion of this session, participants should be able to:- Increase their knowledge about the most recent international guidelines on Post-Approval Changes for Pharmaceutical Products issued by WHO (final version) and ICH Q12 (in progress)
- Be prepared for the future regulatory challenges related to post-approval changes
- Identify opportunities of regulatory harmonization/convergence to reduce lifecycle management complexity for patient’s benefit
Speaker(s)
Post Approval Changes - How to be Prepared for the Future
Global Head Regulatory Policy; F. Hoffmann - La Roche Ltd., F. Hoffmann - La Roche AG, Switzerland
ICH Q12 Industry Perspective
Global Head Regulatory CMC, GRAPSQA, AstraZeneca, United Kingdom
WHO Post Approval Changes Guideline for Biotech Products
Associate Director, BRDD, Health Canada, Canada
ANVISA´s Experience as an ICH Q12 Member and the Process of Local Implementation
Health Regulatory Expert,Post-approval's Office Small Molecules Drug Products, ANVISA, Brazil
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