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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)
Post Approval Change Management: FDA Perspective
Christine Moore, PHD
Organon & Co., United States
Executive Director, Global External Advocacy and Standards
Post Approval Life Cycle Change Management - Completing What Quality by Design Intended to Deliver
Roger Nosal, PHD
Pfizer Inc, United States
Vice President, Head of Global CMC
GDUFA Impacts on Post-Approval Changes – The Real Deal
Barinder Sandhu, MBA, RAC
Teva Pharmaceuticals, United States
Sr. Director, Regulatory Affairs, US Generics