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Session 3 Track A: Nitrosamine Impurities, Lessons Learned
Session Chair(s)
Kristin Willemsen, MS
Vice President, Scientific & Regulatory Affairs
Food, Health & Consumer Products of Canada, Canada
Gary Condran
Manager, Quality Risk Management and Operations Division, Bureau of Pharmaceutic
Health Canada, Canada
Marc Poitras, PhD, MBA
Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau
Health Canada, Canada
In mid-2018, the detection of N-nitrosamines in some Angiotensin II Receptor Blockers (commonly known as sartan drugs) led to product recalls worldwide. This session will discuss the root causes and the risk minimization measures taken in Canada and internationally. In addition, the experience gained from the sartan case and other products afforded the opportunity to assess the lessons learned and how to prevent similar incidents in the future.
Learning Objective : - Discuss underlying causes for contamination and potential sources of nitrosamines impurities
- Outline the activities taken by both regulatory authorities and manufacturers to mitigate the risks of N-nitrosamine contamination in various Active Pharmaceutical Ingredients (APIs) and drug products
- Determine what lessons have been learned and how to prevent N-nitrosamines from being present in medicines in the future
Speaker(s)
Dealing with the Nitrosamines Issue in Canada
Stephen Horne, PhD
Health Canada, Canada
Senior Evaluator,Bureau of Pharmaceutical Sciences
EMA Update on N-nitrosamines Impurities Case
Andrei Spinei, MPharm, MSc
European Medicines Agency, Netherlands
Scientific Administrator
Nitrosamine Impurities – An Industry Perspective
Tony Bristow, PhD
AstraZeneca, United Kingdom
Principal Scientist for Measurement Science, Chemical Development