Learning Tracks

After two years of FDA Guidance and of USP’s General Chapter Nitrosamines Impurities publications, what have industry, FDA, and USP learned? This session will explain the drug safety situation that the USP General Chapter and FDA guidances were responding to, what these resources cover in terms of the analytical methods that manufacturers can use to identify possible nitrosamines in their products, the background behind the limits prescribed in the Agency’s guidance, and what’s on the horizon. Additionally, this session will highlight the latest issues related to nitrosamines such as the perspective of using molecular weight to set acceptable intake limits for nitrosamines.

Moderator: Aloka Srinivasan, PhD
Principal and Managing Partner, RAAHA Consulting LLC

Speakers:
Edmond Biba, PhD
Principal Scientist, General Chapters, USP

Martin Ehlert, PhD
Vice President, GRD Global API Technical, Apotex Inc.

Robert Heflich, PhD
Director, Division of Genetic and Molecular Toxicology, National Center for Toxicological Research, Office of the Chief Scientist, FDA

Raphael Nudelman, PhD, ERT
Senior Director Impurity Expert, R&D Operations, Teva Pharmaceutical Industries Ltd.

Andre Raw, PhD 
Associate Director for Science and Communication, Office of Lifecycle Drug Products (OLDP), OPQ, CDER, FDA

Panelists:
Sruthi King, PhD
Deputy Director, Division of Pharm Tox Review, Office of Safety and Clinical Evaluation, OGD, CDER, FDA