🌟 Expert Lecture at the Institute of Pharmacy, Nirma University 🌟
The Institute of Pharmacy, Nirma University, organized an engaging expert lecture on 24 March 2026 titled “Managing the Regulatory Lifecycle of Products in the USA: Key Processes and Case Studies.”
🎤 The session was delivered by Dr. Darshan Doshi, DGM – Regulatory Affairs at Zydus Lifesciences, shared valuable insights on post-approval changes (PAC) and lifecycle management in the US regulatory framework.
📊 Through real case studies, he explained key pathways like PAS, CBE-30, CBE-0, and Annual Reports, along with their evaluation by the United States Food and Drug Administration.
👩🔬 The interactive session provided valuable, case-driven learning for students, enhancing their understanding of real-world regulatory practices.