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Virtual Event

Oct 19, 2020 9:55 AM - Oct 20, 2020 5:30 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA Annual Canadian Meeting

Session 3 Track A: Nitrosamine Impurities, Lessons Learned

Session Chair(s)

Kristin  Willemsen, MS

Kristin Willemsen, MS

Vice President, Scientific & Regulatory Affairs

Food, Health & Consumer Products of Canada, Canada

Gary  Condran

Gary Condran

Manager, Quality Risk Management and Operations Division, Bureau of Pharmaceutic

Health Canada, Canada

Marc  Poitras, PhD, MBA

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)

Stephen  Horne, PhD

Dealing with the Nitrosamines Issue in Canada

Stephen Horne, PhD

Health Canada, Canada

Senior Evaluator,Bureau of Pharmaceutical Sciences

Andrei  Spinei, MPharm, MSc

EMA Update on N-nitrosamines Impurities Case

Andrei Spinei, MPharm, MSc

European Medicines Agency, Netherlands

Scientific Administrator

Tony  Bristow, PhD

Nitrosamine Impurities – An Industry Perspective

Tony Bristow, PhD

AstraZeneca, United Kingdom

Principal Scientist for Measurement Science, Chemical Development

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