Learning Tracks

In this session, industry panelists will discuss how they are working across multiple, global health authorities to address Nitrosamine considerations and provide their perspective on how it is preparing for Nitrosamines limits. Industry will provide examples of inconsistencies across different global authorities, the challenges this creates, and outline recommendations on how Industry can work with the FDA (and other HAs) to address these challenges, so patients continue to have access to needed products.

Moderator: Giuseppe Randazzo
Senior Vice President, Sciences and Regulatory Affairs, AAM

Sanjeeva Chinnakadoori, PhD
Senior Research Scientist/Associate Director, Analytical R&D, Amneal Pharmaceuticals

Vijaya Iyer, M.S.
Senior Director, Global Regulatory Affairs PLCM & Regulatory Compliance, Apotex

Arpitha Chepyala, MSc
Associate Director, Dr. Reddy’s Laboratories Inc.

Nalin Karkra
General Manager, Sun Pharmaceuticals

John “JD” Derstine
Senior Director, Generics Regulatory Affairs, Teva Pharmaceuticals