EMA Information Day on Risk Management Planning – Implementation of GVP V and RMP Template Rev 2 Guidance

REGISTER EARLY! This Information Day is aimed at providing MAHs and MAAs with practical advice on RMP drafting using the principles of risk assessment and management included in GVP V Rev 2.

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CHALLENGES IN IMPLEMENTING THE UPDATED RMP GUIDANCE – STAKEHOLDERS’ PERSPECTIVE

Session Chair(s)

Jordi Llinares Garcia, MS

Head of Research and Innovation

European Medicines Agency, Netherlands

Zeljana Margan Koletic

HALMED, Croatia

PRAC and Industry’s perspectives on the implementation of the updated guidance will be complemented by additional EMA guidance and advice on procedural aspects of RMP submission.

Speaker(s)

PRAC perspective on RMP guidance

Sabine Straus, MD, PHD, MSC

Medicines Evaluation Board (MEB), Netherlands

Former PRAC Chair

Procedural aspects of RMP update – EMA advice on procedural topics raised by stakeholders

Emil Andrei Cochino, MD, MHS

European Medicines Agency, Netherlands

Scientific Senior Specialist (Risk Management)

Procedural aspects of RMP update – EMA advice on procedural topics raised by stakeholders

Nuria Semis-Costa, MSC

European Medicines Agency, Netherlands

Scientific Specialist (Risk Management)

RMP guidance implementation – Industry perspective

Valerie E. Simmons, MD, FFPM

Eli Lilly and Company Ltd, United Kingdom

Senior Medical Fellow, Global Patient Safety

EMA Information Day on Risk Management Planning – Implementation of GVP V and RMP Template Rev 2 Guidance

CHALLENGES IN IMPLEMENTING THE UPDATED RMP GUIDANCE – STAKEHOLDERS’ PERSPECTIVE

Session Chair(s)

Jordi Llinares Garcia, MS

Zeljana Margan Koletic

Speaker(s)

PRAC perspective on RMP guidance

Procedural aspects of RMP update – EMA advice on procedural topics raised by stakeholders

Procedural aspects of RMP update – EMA advice on procedural topics raised by stakeholders

RMP guidance implementation – Industry perspective

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