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Pharmacovigilance Strategies Workshop

Navigating the changing PV landscape in your daily work. Anniversary edition: 5 years


Session 3: Practical approaches and innovations in Risk Minimisation and Pharmacovigilance activities

Session Chair(s)

Wendy  Huisman, PharmD

Wendy Huisman, PharmD

  • Director
  • Vigifit, Netherlands
Bianca  Mulder, PharmD, MPharm, MSc

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

Gravitate Health Background and the Potential for Pharmacovigilance (E.g: Risk Minimization)

Giovanna Ferrari, PhD

  • Regional Labelling Lead
  • Pfizer Ltd, United Kingdom
Gabrielle  Amselem

Harmonisation of Educational Material Between Member States

Gabrielle Amselem

  • Deputy EU/UK QPPV
  • Alexion, France
Stephanie  Tcherny- Lessenot, MD, MPH, MSc

Experience when Working in a Consortium

Stephanie Tcherny- Lessenot, MD, MPH, MSc

  • Head of Benefit-Risk Evaluation, Epidemiology & Benefit-Risk Evaluation
  • Sanofi, France
Inge  Zomerdijk, MSc

Experience when Working in a Consortium

Inge Zomerdijk, MSc

  • Pharmacovigilance Assessor
  • Medicines Evaluation Board (MEB), Netherlands