EMA Information Day on Risk Management Planning

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GVP V REVISION 2: PRACTICAL APPROACH ON IMPLEMENTATION OF REVISED RMP TEMPLATE REV 2 GUIDANCE

Session Chair(s)

Sabine Straus, MD, PhD, MSc

PRAC Chair, Staff Member

Medicines Evaluation Board (MEB), Netherlands

This session will provide practical advice and insights on the implementation of the revised RMP template from EMA, industry and regulator perspective. Based on questions received from the audience, the panel invites to an interactive discussion on the experience with the implementation of the GVP V Revision 2 template.

Speaker(s)

GVP V and RMP Template Revision 2 – Implementation progress; updates on the EMA project Quality of the RMP submissions

Nuria Semis-Costa, MSc

European Medicines Agency, Netherlands

Scientific Specialist (Risk Management)

Lessons From 200 Updated RMPs

Jan Petracek, MD, MSc

Ivigee, Czech Republic

CEO

Revision of GVP Module V: Experiences from the Regulators

Inge Zomerdijk, MSc