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Virtual

Nov 21, 2024 1:30 PM - Nov 21, 2024 5:30 PM

(Central Europe Standard Time)

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.

Session 1 - first experiences and practical aspects

Session Chair(s)

Ulla  Wändel Liminga, DrMed, MS, RPh

Ulla Wändel Liminga, DrMed, MS, RPh

Scientific Director Pharmacology/Toxicology

Medical Products Agency (MPA), Sweden

Speaker(s)

Harshil  Patel, MPharm

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

Harshil Patel, MPharm

Novartis , India

Senior Manager AR&RM – RMP

Luvanka Kalliopi  Hanxhari

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

Luvanka Kalliopi Hanxhari

Novartis, Switzerland

Senior Manager AR&RM – RMP

Robert  Massouh, MPharm, RPh

Industry perspective regarding joint PASS studies

Robert Massouh, MPharm, RPh

GSK, United Kingdom

Head of (Safety) Risk Management and Benefit/Risk Evaluation

Vicki  Edwards, RPh

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

Vicki Edwards, RPh

Abbvie, United Kingdom

Vice President, Pharmacovigilance Excellence and International QPPV

Ryan  Marshall

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

Ryan Marshall

AstraZeneca, United Kingdom

Associate Director, Risk Management

Jan  Petracek, MD, MSc

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

Jan Petracek, MD, MSc

Ivigee, Czech Republic

CEO

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