Areas Covered in the Session The Impact of the key changes The challenges and scientific questions raised during the preparation of RMPs Examples from Industry Feedback from Regulators Learning Objectives To understand the impact of the key changes to GVP Module V

1. About Us Webinars
EU Risk Management Plans- Experience
one Year Post GVP Module V Revision
ENROLL
LIVE WEBINAR
Date: Tuesday, September 4, 2018
Time: 11:00 AM CEST
Duration: 60 Minutes
Instructor: Jan Jepras
OVERVIEW
The presentation will provide an overview of Risk Management Plan preparation one year
after implementation of the revised GVP Module V and Template Rev 2. The impact of the
key changes to the production of both new and updated RMPs will be discussed with real
examples.
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ABOUT INSTRUCTOR
Jan Jepras , is a pharmacovigilance consultant with over 20 years
experience of drug safety across all phases of drug development. Jan
was a Pharmacovigilance Manager at GSK between 1999 and 2010 and
has been an independent consultant since then working with a variety of
clients both big and small including Takeda, Public Health England.
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