Fast Forward Guest Series Edition 17
π Date: January 24, 2025
β° Time: 5:15PM - 6:00PM IST
π Speaker: Aparna Kamatha, Assist. General Manager, Aristo
π Theme: Regulatory Landscape of Drug Regulations of India
This Lecture will give you insights about Drug Approval Process in India: Steps involved in obtaining approval for new drugs, generics, and biosimilars.
Requirements for clinical trials and bioequivalence studies. Importance of monitoring the safety and efficacy of drugs post-approval.
Discussion on Adverse Drug Reaction (ADR) reporting and risk management systems. Importance of adhering to Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).
Zoom Link: https://zoom.us/j/94605633281?pwd=LVDZWxSR0aFPCJhvNfpY4FOLna8jDk.1