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Session 5: Risk Management Plan: Challenges and Opportunities
Session Chair(s)
Jan Petracek, MD, MSC
CEO
iVigee Services a.s., Czech Republic
Doris Irene Stenver, MD, MPA
Independent Pharmacovigilance Adviser
Unique Advice, Denmark
The guidelines for risk management plans (RMPs) evolved over time but there are still some questions on the content and how to develop it. What are the expectations of the PRAC? How it is assessed by the authorities? What are the main weaknesses of the RMPs provided by the license holders and how to improve them?
Speaker(s)
Practical Aspects of EU RMP for Generics
Olga Mariscal
iVigee, Spain
Director
Lessons Learned from 100 EU-RMPs Submitted 2013-2017 - Will the New EU GVP Module V Help?
Jan Petracek, MD, MSC
iVigee Services a.s., Czech Republic
CEO
RMP Experiences – A PRAC Perspective
Doris Irene Stenver, MD, MPA
Unique Advice, Denmark
Independent Pharmacovigilance Adviser