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Radisson Blu International Airport

2023年5月25日 (木) 午前 9:00 - 2023年5月26日 (金) 午後 5:30

Metro Station, Marol Maroshi Rd, near Marol, Bori Colony, Gamdevi, Marol,, Andheri East,, Mumbai 400059, MH, India

Re-designing and Transforming PV for Augmenting Patient Safety

Session 7 : Changing Landscape of Materiovigilance

Session Chair(s)

Ashish  Indani

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

Changing Landscape of Materiovigilance - Complaint Intake to Periodical Safety Update Report

Ashish Indani

Krishnamugdha Advance ResearchTeck, India

Managing Director

Omprakash  Sadhwani

Dialogue presentation: Materiovigilance from view of Patient Safety Versus Device Safety

Omprakash Sadhwani

Maharashtra Food and Drug Administration, India

Director, XPLORE Healthcare Soln; Ex-Joint Commissioner (HQ) & Drugs Controller

Susan  Korah

Dialogue presentation: Materiovigilance from view of Patient Safety Versus Device Safety

Susan Korah

Tata Consultancy Services, India

Delivery Head- Healthcare and MedTech,

Shatrunajay  Shukla

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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