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Session 7 : Changing Landscape of Materiovigilance
Session Chair(s)
Ashish Indani
Managing Director, Krishnamugdha Advance ResearchTeck, 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)
Ashish Indani
Managing Director, Krishnamugdha Advance ResearchTeck, India
Changing Landscape of Materiovigilance - Complaint Intake to Periodical Safety Update Report
Omprakash Sadhwani
Director, XPLORE Healthcare Soln; Ex-Joint Commissioner (HQ) & Drugs Controller, Maharashtra Food and Drug Administration, India
Dialogue presentation: Materiovigilance from view of Patient Safety Versus Device Safety
Susan Korah
Delivery Head- Healthcare and MedTech,, Tata Consultancy Services, India
Dialogue presentation: Materiovigilance from view of Patient Safety Versus Device Safety
Shatrunajay Shukla
Scientific Assistant MvPI , Indian Pharmacopoeia Commission, India
Regulator’s View-point in Positioning Medical Device Vigilance in India in the Changing Regulatory Landscape
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