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Session 9B: Post-Approval Change Management Protocols
Session Chair(s)
Moheb M. Nasr, PhD, MS
Principal
Nasr Pharma Regulatory Consulting, United States
A post-approval change management protocol describes changes that a company would like to implement during the lifecycle of the product and how these would be prepared and verified. The use of post-approval protocols can greatly facilitate life-cycle management of CMC. However, the utilization of post-approval management protocols has not been widely embraced by industry. Additional experience and regulatory clarity could speed up implementation. Leading regulators, from Europe and United States, and industry speakers will share their perspectives on the utilization of post-approval management protocols, outline implementation challenges and provide suggestions to facilitate preparation and approval. Presentations will be followed by panel discussions
Speaker(s)
Regulatory Consideration For The Development And Filing Of Post-Approval Management Protocols – EU Perspective
Jean-Louis Robert, PhD
Luxembourg
Former CHMP/CVMP QWP Chair
Regulatory Consideration For The Development And Filing Of Post-Approval Management Protocols – FDA Perspective
Christine Moore, PhD
Organon & Co., United States
Executive Director, Global External Advocacy and Standards
Utilization Of Post-Approval Management Protocols In The Implementation Of Quality By Design (Qbd) For Biological Drug Products
Lynne Krummen, PhD
Genentech, A Member of the Roche Group, United States
Vice President, Technical Regulatory, Biologics
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