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Session 6, Track A: Nitrosamine Impurities – What’s New and Where Do We Stand?
Session Chair(s)
Marcia Sam
Senior Manager, Regulatory Affairs, Regeneron Canada Company, Canada
Tharany Ganesh, MSC
Head, Regulatory Affairs, AstraZeneca Canada Inc., Canada
The evaluation and management of risks associated with N-nitrosamine impurities in medications is a global effort. Since the introduction of the calls for review and guidance relating to nitrosamine impurities in 2019, there have been further developments and experience gained by both regulators and industry globally. This session will provide Health Canada’s and other regulator’s current thinking on this subject with an overview of the requirements and approaches being taken to mitigate and manage risks. Industry perspectives on managing these requirements both globally and within Canada will be discussed. As close collaboration with international regulatory bodies has been an integral step taken by Health Canada and industry, information on international collaboration with global regulators and the Nitrosamines International Strategic and Technical Working Groups on the development and understanding of the issues associated with nitrosamine impurities will also be shared.
Learning Objective : - Understand the global industry and regulator experiences and perspectives on managing these issues and the impact on local and global drug development and supply strategies
- Comprehend the quality and safety topics surrounding nitrosamine impurities
- Define specific attributes of HC’s regulatory requirements on HC’s Nitrosamines Impurities Guidance and utilization of international collaboration to inform regulatory requirements and decisions
Speaker(s)
Gary Condran
Manager, Quality Risk Management and Operations Division, Bureau of Pharmaceutic, Health Canada, Canada
Health Canada N-Nitrosamine Impurities Update
Jason Bunting, PHARMD
Science Policy Analyst, Office of the Center Director, CDER, FDA, United States
Recommended Acceptable Intake Limits for Nitrosamine Drug-Substance Related Impurities (NDSRIs)
Gair Ford, PHD
Global Regulatory Affairs Director, CMC, AstraZeneca Global, United Kingdom
The Nitrosamines Journey: Industry Quality Perspective
Joel Bercu, PHD, MPH
Executive Director, Gilead Sciences, United States
Nitrosamines – What’s Next
Alisa Vespa, PHD
Senior Scientific Evaluator/Safety Subject Matter Expert, Risk Management Divisi, Health Canada, Canada
Panelist
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