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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - N-Nitrosamines Contamination Case Lessons Learned

Session Chair(s)

Andrei  Spinei, MPharm, MSc

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

N-Nitrosamine Impurities Case: EMA Update

Andrei Spinei, MPharm, MSc

European Medicines Agency, Netherlands

Scientific Administrator

Gary  Condran

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

Brad  Leissa, MD

FDA Update

Brad Leissa, MD

FDA, United States

Deputy Director, Counter-Terrorism and Emergency Coordination Staff, OCD, CDER

Ganapathy  Mohan, PhD

Nitrosamines in Pharmaceuticals: Challenges and Progress – Industry Perspectives

Ganapathy Mohan, PhD

Merck & Co., Inc., United States

Head of External Affairs (Quality)

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