The Institute of Pharmacy organized an expert lecture for M. Pharm semester II students specializing in Regulatory Affairs, as well as B. Pharm Semester VIII students taking the Pharmaceutical Regulatory Science Elective course. The event took place on April 22, 2024, and featured Mr. Darshan Doshi, Deputy General Manager of Regulatory Affairs at Zydus Lifesciences, Ahmedabad. Mr. Doshi’s talk focused on post-approval life cycle management in the USA. He discussed the activity flow following ANDA submission, various categories of changes, and their management strategies. The session was interactive, with participants engaging in real-time activities based on case studies to better understand the specifics of post-approval changes and their handling.
