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Learning Tracks

Nitrosamines in Pharmaceuticals: Where the Industry and Agency Stands

Tuesday, November 9, 2021

1:30 p.m. - 3:30 p.m.

Nitrosamines, a well-known class of carcinogens, have become a focus of global regulatory agencies, including FDA, due to the discovery of trace amounts of these compounds in angiotensin II receptor blockers (ARB) in 2018, followed by several other products. FDA published a guidance on Control of Nitrosamine Impurities in Human Drugs in September 2020 and held several workshops, including one  March 29-30 regarding its expectations related to control of nitrosamines in chemically synthesized pharmaceuticals. FDA also met with trade organizations representing generic drugs, innovator products and OTC to hear their concerns and provided its responses to many pharmaceutical industry inquiries. Despite the communications, due to inherent complexity of the issue, there are several unanswered questions for the industry. This session will address some of the open issues related to nitrosamine impurities based on the outcome of the Industry and FDA interactions. Some of the key topics of discussion are related to feasibility of using less than lifetime principle in evaluating the nitrosamine related risk, the relevance of read across for nitrosamines with insufficient information in the public domain, the role of AMES test and other in vitro and in vivo tests for evaluation of safety levels of nitrosamines and the use of ICH M7 Option 4 for control of nitrosamines impurities.

Moderator: Aloka Srinivasan, PhD
Chief Executive Officer, RAAHA Consulting

Joel Bercu, PhD, MPH, DABT
Senior Director Nonclinical Safety and Pathobiology, Gilead Sciences, Inc.

Robert Dorsam, PhD
Director, Division of Pharm Tox Review, Office of Safety & Clinical Evaluation, OGD, CDER, FDA

Martin Ehlert, PhD
Global API R&D, Apotex Inc.

Tim Marzan, MS
Chemist, Division of Pharmaceutical Analysis, Office of Testing and Research, OPQ, CDER, FDA

Valerie Niddam-Hildesheim, PhD
Senior Director, Global Nitrosamines Project Lead Global Medical Affairs & Pharmacovigilance, Teva Pharmaceuticals

Andre Raw, PhD
Senior Science and Policy Advisor, Office of Lifecycle Drug Products, OPQ, CDER, FDA

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