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Session 6, Track A: Nitrosamine Impurities – What’s New and Where Do We Stand?
Session Chair(s)
Marcia Sam
Regulatory Affairs Strategy and Policy Manager
Hoffmann-La Roche Canada Limited, Canada
Tharany Ganesh
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)
Health Canada N-Nitrosamine Impurities Update
Gary Condran
Health Canada, Canada
Manager, Quality Risk Management and Operations Division, Bureau of Pharmaceutic
Recommended Acceptable Intake Limits for Nitrosamine Drug-Substance Related Impurities (NDSRIs)
Jason Bunting, PharmD
FDA, United States
Science Policy Analyst, Office of the Center Director, CDER
The Nitrosamines Journey: Industry Quality Perspective
Gair Ford, PhD
AstraZeneca Global, United Kingdom
Global Regulatory Affairs Director, CMC
Nitrosamines – What’s Next
Joel Bercu, PhD, MPH
Gilead Sciences, United States
Executive Director
Panelist
Alisa Vespa, PhD
Health Canada, Canada
Senior Scientific Evaluator/Safety Subject Matter Expert, Risk Management Divisi
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