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Session 3: MATEROVIGILANCE
Session Chair(s)
Sumati Randeo
MD & Founder, QR Synergies, India
Session Overview: DIA invites industry leaders to a focused session on strengthening medical device safety through regulatory alignment, robust vigilance practices, and collaborative action. This session will explore how evolving regulatory frameworks intersect with global standards and what that means for manufacturers, regulators, and healthcare providers. Attendees will examine practical approaches to turning adverse event data into effective risk mitigation, covering reporting pathways, root cause analysis, and corrective and preventive strategies that improve device performance and patient outcomes. A multi stakeholder dialogue will highlight ways to elevate reporting culture and data quality, balance innovation with patient safety, and foster transparency and shared accountability across the ecosystem. Participants will gain actionable insights for harmonizing compliance strategies, enhancing post market surveillance, and implementing scalable vigilance processes that reduce risk and support product lifecycle management. This session is designed for senior executives, regulatory affairs and quality leaders, clinical safety professionals, and policy makers seeking high value, practical guidance. Join peers, regulators, clinicians, and patient advocates to exchange best practices, identify collaboration opportunities, and leave with a clear roadmap to strengthen Materiovigilance Program, protecting patients while enabling responsible innovation.
Speaker(s)
Global Medical Device Reporting and Materiovigilance Program in India: Building a Unified Safety Framework for Medical Devices
Miang Tanakasemsub
Regional RA head, APJ Vision, Johnson & Johnson – Singapore, India
Participating Panelist
Prashanth Prabhakar
Associate Director Regulatory Affairs, India & ASEAN, Boston Scientific , India
Shatrunajay Shukla
Scientific Assistant MvPI , Indian Pharmacopoeia Commission, India
Rajat Saxena
Lead Quality & Regulatory Affairs SEA & India SC, Cordis, India
Participating Panelist
Preety Sharma
Head - Regulatory Affairs, Edwards Lifesciences, India
From Adverse Event Reporting to Risk Mitigation: Strengthening Medical Device Reporting / Materiovigilance Systems
Rama Sethuraman
Head of Quality and Regulatory Asia Pacific, Roche, India
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