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Thursday, June 18 • 5:00pm - 6:00pm
#557 OD: ON DEMAND - N-Nitrosamines Contamination Case Lessons Learned

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Component Type: Session
Level: Advanced

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 Objectives

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.

Chair

Andrei Spinei, MPharm, MSc

Speaker

N-Nitrosamine Impurities Case: EMA Update
Andrei Spinei, MPharm, MSc

Health Canada’s Experiences Responding to the Global Nitrosamines Issue
Gary Condran

FDA Update
Brad Leissa, MD

Nitrosamines in Pharmaceuticals: Challenges and Progress – Industry Perspectives
Ganapathy Mohan, PhD


Speakers
avatar for Gary Condran

Gary Condran

Manager, Generic Drugs Quality Division, Bureau of Pharmaceutical Sciences, TPD, Health Canada, Canada
After being employed for several years in the Regulatory Affairs Departments of two multi-national pharmaceutical companies in the Toronto area, Gary Condran re-joined Health Canada in 1995 as a Senior Quality Assessor. He has since progressed in several capacities within the department... Read More →
avatar for Ganapathy Mohan

Ganapathy Mohan

Head of External Affairs (Quality), Merck & Co., Inc., United States
Ganapathy Mohan leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until April 2017, he was the head of Small Molecule Development Quality. Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015. Prior to joining... Read More →
avatar for Brad Leissa

Brad Leissa

Deputy Director, Counter-Terrorism and Emergency Coordination Staff, OCD, CDER, FDA
Brad Leissa began his career at FDA in 1989 as a Medical Officer in the Center for Drug Evaluation and Research (CDER). Following the October 2001 anthrax attacks, Dr. Leissa began work on drug-related regulatory emergencies. In June 2018, he became the lead coordinator for the CDER... Read More →
avatar for Andrei Spinei

Andrei Spinei

Scientific Administrator, European Medicines Agency
Andrei Spinei is a Scientific Administrator in the Quality and Safety of Medicines Department at EMA working on GMP, quality defects and product recalls, sampling and testing and international collaborations on GMP and inspections. He holds an MSc. in Pharmacy and before joining the... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session