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Combination Products Conference
Welcome, Opening Remarks, and Keynote Address – Future of Medicine: Combination Products
James Wabby, MHS
- Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
- Abbvie, United States
Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.
Learning Objective : At the conclusion of this session, participants should be able to:
- Analyze the latest Office of Combination Products (OCP) regulatory expectations and challenges
- Recognize potential future innovation platforms
- Identify potential and future Global Convergence/Harmonization initiatives for combination products
Future of Medicine: Combination Products
Thinh X. Nguyen
- Director, Office of Combination Products, OCPP
- FDA, United States
Primer: APPs/Digital Health in Combination Products - QMS and Risk Management Opportunities and Challenges