戻る Agenda
GVP V REVISION 2: PRACTICAL APPROACH ON IMPLEMENTATION OF REVISED RMP TEMPLATE REV 2 GUIDANCE
Session Chair(s)
Sabine Straus, MD, PhD, MSc
Former PRAC Chair
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 Services a.s., Czech Republic
CEO
Revision of GVP Module V: Experiences from the Regulators
Inge Zomerdijk, MSc
Medicines Evaluation Board (MEB), Netherlands
Pharmacovigilance Assessor