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Session 3: Practical approaches and innovations in Risk Minimisation and Pharmacovigilance activities
Session Chair(s)
Wendy Huisman, PHARMD
VP Quality and Patient Safety, Avanzanite Bioscience, 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)
Giovanna Ferrari, PHD
Regional Labelling Lead, Senior Director, Pfizer Ltd, United Kingdom
Gravitate Health Background and the Potential for Pharmacovigilance (E.g: Risk Minimization)
Gabrielle Amselem, PHARMD
Dir, Pharmacovigilance Excellence Expert, Alexion, AstraZeneca Rare Disease, France
Harmonisation of Educational Material Between Member States
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
Experience when Working in a Consortium
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