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Session 1: REGULATORS INTERACTION
Session Chair(s)
Kamal Shahani
Managing Director, Tenet Health Edutech Pvt. Ltd. (Cliniminds, CRQA, Thinki & Mediminds), India
Session Overview: This session will explore evolving, 360 degree engagement between industry and regulators across the clinical and post marketing safety continuum. Discussion will focus on proactive communication strategies, expectation setting for safety data, signal detection and management, benefit–risk assessment, and use of real world evidence. Speakers will share recent experiences with regulatory queries, inspections, labeling negotiations, and risk minimization commitments, highlighting best practices, common pitfalls, and opportunities to leverage digital tools and advanced analytics to enhance transparency, timeliness, and trust in safety decision making.
Speaker(s)
Panel Discussion: Strengthening Pharmacovigilance in India: From Compliance to Public Health Impact Moderator
Vivek Ahuja
Program Chair-PV Track, Executive Vice President, Pharmacovigilance, EVERSANA, India
Panel Discussion: Strengthening Pharmacovigilance in India: From Compliance to Public Health Impact
Omprakash Sadhwani
Director , Tiblo Consultancy Services, India
Dr. K. Narendran
Deputy Drugs Controller (India), DDC(I), CDSCO, Zonal Office & Central Drugs Testing Laboratory (CDTL), Hyderabad, India
Shri Guguloth Ramdhan
oint Director &Licensing Authority (SLA), Drugs Control Administration (DCA), Government of Telangana, Hyderabad, India
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