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Session 3: Practical approaches and innovations in Risk Minimisation and Pharmacovigilance activities
Session Chair(s)
Wendy Huisman, PharmD
Director
Vigifit, Netherlands
Bianca Mulder, PharmD, MPharm, MSc
Pharmacovigilance Assessor
Medicines Evaluation Board, Netherlands
GVP Module XVI provides guidance for the use of additional risk minimisation measures including the selection of tools and their evaluation of their effectiveness. However, throughout Europe the implementation of additional risk minimisation measures, such as educational material, might vary between countries. Furthermore, over the last years we have seen several examples in which different companies marketing the same active substance are working in a consortium to improve the harmonization of these materials and to set up joint Drug Utilisation Studies as is also encouraged in the update of GVP Module XVI. This session will explore examples and points to consider on both topics to help stimulate discussion. There will be perspectives from Industry and the Dutch Regulatory Agency. In addition to hearing from the speakers, attendees will be encouraged to share their experience as part of the Panel Discussion
Speaker(s)
Gravitate Health Background and the Potential for Pharmacovigilance (E.g: Risk Minimization): Giovanna Ferrari, PhD
Regional Labelling Lead, Senior Director
Pfizer Ltd, United Kingdom
Harmonisation of Educational Material Between Member States : Gabrielle Amselem, PharmD
Dir, Pharmacovigilance Excellence Expert
Alexion, AstraZeneca Rare Disease, France
Experience when Working in a Consortium : Stephanie Tcherny- Lessenot, MD, MPH, MSc
Head of Benefit-Risk Evaluation, Epidemiology & Benefit-Risk Evaluation
Sanofi, France
Experience when Working in a Consortium : Inge Zomerdijk, MSc
Pharmacovigilance Assessor
Medicines Evaluation Board (MEB), Netherlands
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