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Session 7: Risk Management Workshop
Session Chair(s)
Francoise Sillan, MD
EU1 UK QPPV
Ipsen, France
The GVP Module V has been updated 2 years ago following fruitful interactions between MAHs and EMA. This session will further explore the lessons learned and pending questions on this update and will address specific challenges for generic products. The MHRA expectations for ongoing and future RMP UK submissions and potential Brexit impact will be discussed.
Speaker(s)
Risk Management Plans – An assessor’s expectations
Shahin Kauser
MHRA, United Kingdom
Leading Senior Scientific Assessor
HaRRP project and RMP for Generics
Kora H Doorduyn-van der Stoep, MSc, RPh
MEB, Netherlands
EU Representative
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