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.

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Session 2 - GVP Module XVI - the 3rd Revision

Session Chair(s)

Sabine Straus, MD, PhD, MSc

Former PRAC Chair, Medicines Evaluation Board (MEB), Netherlands

Speaker(s)

Priya Bahri, PhD

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

The revised GVP Module XVI - What to focus on for implementing the guidance

Thomas Goedecke, PharmD, PhD

Senior Pharmacovigilance Specialist, European Medicines Agency, Netherlands

Conceptional approach to RMM effectiveness evaluation

Liana Martirosyan, DrMed

PRAC Member and PRAC Vice-Chair, Medicines Evaluation Board (MEB), Netherlands

Revised GVP Module XVI - impact research from a regulatory perspective

Roberto Frontini

Former Director of Pharmacy, Centre for Patient Safety Leipzig, Germany

Engagement of patients and healthcare professionals in RMM

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