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Session 2B: Post-Approval Change Management Protocols (PACMP)
Session Chair(s)
Nirdosh Jagota, PHD
Managing Partner, GRQ Biotech Advisors LLC, United States
Wendy Mavroudakis, JD
Senior Director, Global Regulatory Affairs, Johnson & Johnson Pharmaceutical R&D LLC, United States
The focus of this session will be on post approval change management and its application for products in various stages of the life cycle. The speakers will touch on risk based approaches to manage post approval changes and various approaches used in both the generics as well as the branded pharma industry. The speakers will also discuss some of the challenges in the global implementation of changes and discuss steps that need to be taken to facilitate a consistent post approval management pathway that will enable innovation in the industry and help in the utilization of lean principles within the industry.
Speaker(s)
Christine Moore, PHD
Executive Director, Global External Advocacy and Standards, Organon & Co., United States
Post Approval Change Management: FDA Perspective
Roger Nosal, PHD
Vice President, Head of Global CMC, Pfizer Inc, United States
Post Approval Life Cycle Change Management - Completing What Quality by Design Intended to Deliver
Barinder Sandhu, MBA, RAC
Sr. Director, Regulatory Affairs, US Generics, Teva Pharmaceuticals, United States
GDUFA Impacts on Post-Approval Changes – The Real Deal