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Session 3: Appropriate GMPs for Combination Products
Session Chair(s)
Nathan Brown, JD
Health Care and Life Sciences Partner
Akin Gump Strauss Hauer & Feld LLP, United States
The issues surrounding Good Manufacturing Practices (GMPs) for combination products can be complex. This session will review the FDA final guidance, Current GMP requirements for combination products, on streamlined GMPs for combination products. Common GMP issues and approaches for addressing questions or concerns will be discussed. The session will also explore how the 21st Century Cures combination product provisions can be leveraged to resolve GMP issues.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand FDA final guidance describing flexibility for combination product GMPs
- Describe the GMP-related provisions in the 21st Century Cures combination product reforms
- Address some of the frequent issues for drug-led and device-led products
- Identify appropriate mechanisms for resolving GMP-related questions for combination products
Speaker(s)
CGMPs for Combination Products
Diana Salditt
Salditt Regulatory Consulting LLC, United States
Principal Consultant
Cross Labeling Combination Products: Industry Challenges
Kirsten H. Paulson, MS, RAC
Pfizer, Inc., United States
CGMPs for Combination Products
Melissa Burns, MS
FDA, United States
Senior Program Manager, Office of Combination Products, OCPP, OC