Learning Tracks

This session will address key considerations for controlling Nitrosamine Drug Substance-Related Impurities (NDSRIs), including:

1. Timing considerations and potential market impacts
2. FDA’s approach to international regulatory alignment
3. Industry obligations for notifying FDA when nitrosamine levels exceed the AI (e.g., through FARs, OPQ communications, or DSS notifications)

Participants:

Ee-Sunn (Joanne) Chia, PhD
Director, Division of Product Quality Assessment X (DPQA X), OPQA II, OPQ, CDER, FDA

Sanjeeva Chinnakadoori, M.Sc.
Senior Research Scientist, Analytical R and D, Amneal

Nalin Karkra, Ph.D.
General Manager, API Regulatory & Business Continuity, Sun Pharmaceuticals

Sruthi King, PhD
Division Director, Division of Pharmacology/Toxicology Review, Office of Safety and Clinical Evaluation, OGD, CDER, FDA

Moderator:
Vijaya Iyer, MSc
Senior Director, Global Regulatory Affairs PLCM & Regulatory Compliance, Apotex Inc.