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Session 4: QUALITY MANAGEMENT SYSTEMS
Session Chair(s)
Retesh Bhumbak, MD
World Wide Patient Safety Site Head- Hyderabad, Bristol Myers Squibb, India
Kausik Maiti, MD
Vice President, Patient Safety Medical Sciences, Parexel International , India
Session Overview: Quality Management Systems are no longer static compliance constructs in Pharmacovigilance; they are dynamic enablers of patient safety, organizational resilience, and regulatory confidence. This session sets the stage to reflect on how robust QMS frameworks support end to end safety operations—ensuring consistency, transparency, and continuous improvement in an increasingly complex environment. We will explore how quality thinking is embedded across processes, partnerships, and technologies, and how a strong quality culture helps organizations move from reactive issue management to proactive risk anticipation, ultimately strengthening trust in Pharmacovigilance outcomes
Speaker(s)
From Compliance to Intelligence - Reimagining QMS in PV
Arunima Sen
Associate Vice President, Lead-Global Pharmacovigilance Operations, Product Safety and Risk Management, Viatris , India
Panel Discussion with Q&A: CAPA That Sticks: Turning Findings into Preventive System Change
Joydeep Sengupta
General Manager and Global Head of Pharmacovigilance, Curateq Biologics (Aurobindo Pharma Company) , India
Anju Agarwal
Global Director -Patient Safety, ADVANZ PHARMA , India
Ankur Borkakoty
Head of Safety Case Processing , Novartis, India
Dr. Sailaja Sayana
Medical Safety Group Head, Sandoz India Pvt Ltd, India
A PV QMS Turnaround Story: From Inspection-Readiness Assessment to Sustained Readiness
Kausik Maiti, MD
Vice President, Patient Safety Medical Sciences, Parexel International , India
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