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ON DEMAND - N-Nitrosamines Contamination Case Lessons Learned
Session Chair(s)
Andrei Spinei, MPharm, MSc
Scientific Administrator, European Medicines Agency, Netherlands
Following the sartans contaminations with N-nitrosamines leading to worldwide recalls, the session would discuss the causes, risk minimization measures taken internationally and the lessons learned and how to prevent similar incidents in the future.
Learning Objective : Discuss underlying causes for contamination, identify actions taken by worldwide regulatory authorities and manufacturers to mitigate risk; Identify the challenges to dealing with the case; Discuss lessons learned by industry and regulatory authorities.
Speaker(s)
Andrei Spinei, MPharm, MSc
Scientific Administrator, European Medicines Agency, Netherlands
N-Nitrosamine Impurities Case: EMA Update
Gary Condran
Manager, Quality Risk Management and Operations Division, Bureau of Pharmaceutic, Health Canada, Canada
Health Canada’s Experiences Responding to the Global Nitrosamines Issue
Brad Leissa, MD
Deputy Director, Counter-Terrorism and Emergency Coordination Staff, OCD, CDER, FDA, United States
FDA Update
Ganapathy Mohan, PhD
Head of External Affairs (Quality), Merck & Co., Inc., United States
Nitrosamines in Pharmaceuticals: Challenges and Progress – Industry Perspectives
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