Pharmacovigilance and Risk Management Strategies Conference

This session will provide an update on the current state of EU pharmacovigilance regulations, bringing in EMA, Industry, and patient perspectives.

In particular, the discussions will focus on the findings and recent trainings of the SCOPE (Strengthening Collaboration for Operating Pharmacovigilance in Europe) Joint Action, a three-year project to help medicines regulators operate pharmacovigilance systems according to the EU legislative requirements. Latest updates on the Good Pharmacovigilance Practices (GVP) measures will include the new chapter on Biological medicinal products and status of the new Module VI on Management and reporting of adverse reactions to medicinal products.

“Has the EU pharmacovigilance legislation translated to better safety outcomes for patients?” A special panel of patient, industry, academic, and regulatory stakeholders will examine the implementation of the 2012 legislation and whether there has been a measurable impact on patient safety. The audience will be invited to join in an interactive Q&A in the latter part of this session.