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Session 5: PV FOR BIOLOGICS/BIOSIMILARS
Session Chair(s)
Shubhadeep Sinha
Sr VP & Global HOD , Hetero Labs Limited, India
Session Overview: PV for Biologics/Biosimilars session will highlight end-to-end (“360°”) safety management for biologics and biosimilars, focusing on proactive risk identification, real-world evidence integration, and continuous benefit–risk evaluation. This session will bring together perspectives from industry, regulators, and clinical experts and will equip attendees with actionable strategies to strengthen pharmacovigilance systems for biologics and biosimilars, ensuring patient safety, regulatory compliance, and sustained trust in these critical therapies. Participants will gain insights into how PV systems are evolving to address product variability, traceability challenges, and switching/interchangeability considerations, which are critical for these therapies.
Speaker(s)
Patient Safety in Biologics’ Therapies
Vamshi Krishna
MD, DM (Medical Oncology), Director and Head, Medical Oncology and Hematology, Institute of Oncology AIG Hospitals, , India
Panel Discussion with Q&A: Collaborations from Regulators, MAH and Cross Functional Stockholders for PV for Biologcs/Biosimilar
Prof. (Dr.) Bikash Medhi
Head of Department, Pharmacology, PGIMER, India
Debashish Dutta, MSc
Associate Director - Global Regulatory Affairs, Dr. Reddy's Laboratories Ltd. (Biologics), India
Dr Pranjal Bordoloi, MD
Senior Vice President, Late Phase – Operations, Lambda Therapeutic Research Ltd., India
Lifecycle of Pharmacovigilance for Biologics Therapy: Study to Market
Nitu Sinha
Vice President & Global Head, Mankind Pharma Ltd, India
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