EMA Risk Management Information Day

The focus of this interactive Information Day will be to exchange first experiences on the implementation of the revised GVP module XVI guideline on risk minimisation measures from different stakeholders' perspectives.

Back to Agenda

Session 1 - first experiences and practical aspects

Session Chair(s)

Ulla Wändel Liminga, DrMed, MS, RPh

Scientific Director Pharmacology/Toxicology, Medical Products Agency (MPA), Sweden

Speaker(s)

Industry Insights: Navigating the implementation of GVP Module XVI Revision 3

Harshil Patel, MPharm

Senior Manager AR&RM – RMP, Novartis , India

Industry Insights: Navigating the implementation of GVP Module XVI Revision 3

Luvanka Kalliopi Hanxhari

Senior Manager AR&RM – RMP, Novartis, Switzerland

Industry perspective regarding joint PASS studies

Robert Massouh, MPharm, RPh

Head of Safety (PV) Risk Management and Benefit/Risk Evaluation, GSK, United Kingdom

GVP XVI (Rev. 3) and considerations for digital aRMM

Vicki Edwards, RPh

Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom

GVP XVI (Rev. 3) and considerations for digital aRMM

Ryan Marshall

Risk Management Director, AstraZeneca, United Kingdom

Use Case - additional risk minimization design and delivery boosted by AI

Jan Petracek, MD, MSc

CEO, iVigee Services a.s., Czech Republic