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Session 6: Patient Safety Special Situations
Session Chair(s)
J Vijay Venkatraman
Managing Director and CEO, Oviya Medsafe Pvt Ltd, India
Session Overview: This session addresses patient safety scenarios that require heightened vigilance and tailored pharmacovigilance approaches in an increasingly complex regulatory and therapeutic environment. Discussions will focus on safety monitoring challenges associated with high impact therapies, evolving inspection expectations, and emerging technologies.The session will explore enhanced safety oversight for GLP 1 agonists, practical strategies for local in country regulatory compliance during inspections, and the potential role of advanced GenAI enabled automation in strengthening pharmacovigilance processes, while maintaining regulatory control and human oversight. The session concludes with a forward looking discussion on patient safety considerations for wearables across clinical trials and real world use. This will include perspectives on data reliability, device performance, user adherence, and the unique challenges wearables introduce when digitally generated measures inform safety monitoring and decision making. Together, these insights will help participants adapt pharmacovigilance systems and oversight practices to emerging wearable technologies within regulated environments.
Speaker(s)
Patient Safety Considerations for Wearables Across Clinical Trials and Real-World Use
Akila Srinivasan
Director, Parexel, India
Panel Discussion: Preparing for Local-in-Country Pharmacovigilance Compliance Expectations During Inspections
Dr.S.Selvakumar
Deputy General Manager, GRA GMA GBS-GPV & DIRM, Apotex GBS, India
Vedraj Vellody
Head of GVP Audit Practice - APAC, ADAMAS Consulting, India
Dr Mohit Trivedi
Country Safety Head India, Sanofi, India
Kabil Kalathingal
Global Head- Medical Assessment,, Dr Reddy's Laboratories, India
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