Autumn Introductory Course 2017 - Day 5

21/11/2017

Conclusions

Summary

• PV and RMP aim to protect patients’ safety • It needs close collaboration with regulatory affairs • RM concerns known risks as well as what we don’t know about the product • PV collects and analyzes safety data and creates reports that need to be produced in time, of good quality and in the right format • Good PV and RM are essential to the safety of patients, prevent crises and keep the product on the market

• Why do we have PV and RM – To protect patients’ safety • Is PV and RM important – YES!!!!! • Does it involves you? – YES!!!!!

PV and Risk Management PH Gerritsen-van Schieveen

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?? Questions ??

• For late questions: Pauline H. Gerritsen-van Schieveen, MD Gerritsen PV Consulting 18 Grande Rue F-70190 La Malachère + 33 384 91 85 29 or + 33 637 26 51 50 GerritsenPVConsulting@orange.fr

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