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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)
N-Nitrosamine Impurities Case: EMA Update
Andrei Spinei, MPHARM, MSC
European Medicines Agency, Netherlands
Scientific Administrator
Health Canada’s Experiences Responding to the Global Nitrosamines Issue
Gary Condran
Health Canada, Canada
Manager, Quality Risk Management and Operations Division, Bureau of Pharmaceutic
FDA Update
Brad Leissa, MD
FDA, United States
Deputy Director, Counter-Terrorism and Emergency Coordination Staff, OCD, CDER
Nitrosamines in Pharmaceuticals: Challenges and Progress – Industry Perspectives
Ganapathy Mohan, PHD
Merck & Co., Inc., United States
Head of External Affairs (Quality)