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Session 7 : Changing Landscape of Materiovigilance
Session Chair(s)
Ashish Indani
Senior Manager – Clinical Affairs Neurovascular
Stryker Global Technology Center, India
The process of medical device vigilance has evolved significantly over years and it continues to evolve with ever evolving technology and a catching up regulations. Materiovigilance, which is also called technovigilance in some countries or broadly product complaint management, has many peculiar requirements with respect to case processing, aggregate reporting, medical coding, causal analysis and regulatory controls. Let’s hear from experts about the process of vigilance for medical devices.
Speaker(s)
Changing Landscape of Materiovigilance - Complaint Intake to Periodical Safety Update Report
Ashish Indani
Stryker Global Technology Center, India
Senior Manager – Clinical Affairs Neurovascular
Dialogue presentation: Materiovigilance from view of Patient Safety Versus Device Safety
Omprakash Sadhwani
Maharashtra Food and Drug Administration, India
Ex-Joint Commissioner (HQ) and Drugs Controller
Dialogue presentation: Materiovigilance from view of Patient Safety Versus Device Safety
Susan Korah
Tata Consultancy Services, India
Head - Delivery, Digital Health and Wellness
Regulator’s View-point in Positioning Medical Device Vigilance in India in the Changing Regulatory Landscape
Shatrunajay Shukla
Indian Pharmacopoeia Commission, India
Scientific Assistant MvPI
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