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Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

Session 2B: Post-Approval Change Management Protocols (PACMP)

Session Chair(s)

Nirdosh  Jagota, PhD

Nirdosh Jagota, PhD

Managing Partner

GRQ Biotech Advisors LLC, United States

Wendy  Mavroudakis, JD

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

Post Approval Change Management: FDA Perspective

Christine Moore, PhD

Organon & Co., United States

Executive Director, Global External Advocacy and Standards

Roger  Nosal, PhD

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

Barinder  Sandhu, MBA, RAC

GDUFA Impacts on Post-Approval Changes – The Real Deal

Barinder Sandhu, MBA, RAC

Teva Pharmaceuticals, United States

Sr. Director, Regulatory Affairs, US Generics

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