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RS.S2. – Global Regulatory Affairs – Achieving Synergy in International Drug Approvals
Session Chair(s)
Gaurav Mathur, PhD
Senior Director, Regulatory Affairs
Parexel International, Bengaluru, India
This session will focus on the challenges and opportunities associated with securing regulatory approvals across multiple international markets. As pharmaceutical companies pursue global drug development and seek synchronized launches, the need for regulatory alignment and collaboration has become more critical than ever. The session will explore current global initiatives such as ICH guidelines, WHO prequalification, and regional harmonization strategies like ASEAN, EU-MDR, etc. It will also examine the practical implementation of reliance models, joint reviews, and mutual recognition agreements. Featuring insights from global regulatory experts and industry veterans, the session aims to uncover actionable strategies that reduce redundancy, enhance efficiency, and ultimately accelerate patient access to innovative therapies across borders.
Speaker(s)
Navigating Through The Changes And Unpredictability Of The Evolving Global Regulatory Landscape
Niyati Shah
COD Research, India
Head - Regulatory Affairs
Post-Approval Change Management: Global Variations & Strategic Approaches
Yogananth Rajendran
Kashiv BioSciences, India
VP Regulatory Affairs
Evolving Global Clinical Development And Regulatory Landscape For Biosimilar Approvals – Time For India To Act
Gursharan Singh
Biocon Biologics, India
GM- Global Clinical Development & Medical Affairs and Portfolio Strategy