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Session 12: An Interactive Discussion: Technical and Regulatory Challenges in Combination Product Lifecycle Management
Session Chair(s)
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
Combination products are a hot topic in healthcare. While these products open doors to exciting new possibilities, they also bring new challenges. This session will discuss the importance of promoting a culture of compliance to build a compliant lifecycle management infrastructure around combination products to ensure appropriate cGXPs and post-market safety reporting regulations are enforced throughout the product’s lifecycle. Open discussions and dialogue will be included.
Learning Objective : At the conclusion of this session, the participant should be able to:- Outline key concepts and updates on the FDA guidance for post-market safety reporting for combination products
- Identify complexities surrounding the additional requirements for the other constituent part that increases internal system infrastructure and risk management challenges
- Discuss best practices and insights in lifecycle management (GxP) programs for combination products
Speaker(s)
FDA: PMSR and Updates
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA: PMSR and Updates
Melissa Burns, MS
FDA, United States
Senior Program Manager, Office of Combination Products, OCPP, OC
PMSR and Industry Perspective
Khaudeja Bano, DrMed, MD, MS
Amgen, United States
Vice President, Combination Product Quality
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