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)

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

Priya Bahri, PhD, RPh

European Medicines Agency, Netherlands

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)

Conceptional approach to RMM effectiveness evaluation

Thomas Goedecke, PharmD, PhD

European Medicines Agency, Netherlands

Senior Pharmacovigilance Specialist

Revised GVP Module XVI - impact research from a regulatory perspective

Liana Martirosyan

Medicines Evaluation Board (MEB), Netherlands

PRAC Member and PRAC Vice-Chair

Engagement of patients and healthcare professionals in RMM

Roberto Frontini

Centre for Patient Safety Leipzig, Germany

Former Director of Pharmacy

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