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Session 4, Track A: Innovation in Therapeutic Product and Device Development
Session Chair(s)
Maria Anillo
Regulatory Affairs Project Manager, AstraZeneca Canada Inc., Canada
My (may) Dang, MBA
Director, Regulatory Affairs, Cencora, Canada
Advances in both therapeutic products and devices pose technical as well as regulatory challenges that must be overcome to ensure safe and effective products. Innovations in Manufacturing also experience regulatory challenges that must be overcome for implementation. In this session we will identify regulatory frameworks, policies and industry experiences to support innovative advanced therapeutic products and devices, as well as new manufacturing technologies.
Learning Objective : - Identify Canadian regulatory frameworks, challenges, and benefits for advanced therapeutics
- Explore decentralized manufacturing's advantages and regulatory hurdles for implementation
- Review the significant strides by jurisdictions in developing policies and how we can leverage the information for successful product development and review by regulatory authorities
Speaker(s)
Canada's Regulatory Approach for Advanced Therapeutic Products
Kenneth Joly, MS
Senior Policy Analyst, Office of Advanced Therapeutic Products, Health Canada, Canada
Innovations in Manufacturing: Decentralized Manufacturing
Celeste Frankenfeld Lamm
Senior Director, Global Quality and Reg CMC Policy, Merck & Co., Inc., United States
Regulatory Challenges and Opportunities in Decentralized Manufacturing: Canadian Perspective
Jennifer Wilhelm, MBA, MS, RAC
Dir, Regulatory Affairs, Merck & Co., Inc., Canada
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