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Session 6: Signal Management: 2 Years into Eudravigilance
Session Chair(s)
Anja Van Haren, MSc
Eudravigilance coordinator
Medicines Evaluation Board (MEB), Netherlands
This session will explore the latest developments in signal detection activities in the EU and how the tools provided by the EMA and other data sources are used to support drug safety monitoring. This session will provide an opportunity to review experience with EudraVigilance from several perspectives more than two years since the launch of the pilot and will discuss the next steps to be taken. Additionally, this session will provide guidance on signal and causality assessment to improve the preparation of cumulative reviews within signal procedures. The Panel Discussion will allow participants to directly interact with individuals working on current issues and future development.
Speaker(s)
Cumulative Reviews in Signal Assessment
Natalie Bandoo
MHRA, United Kingdom
Senior Scientific Assessor
Managing eRMR Assessment for Generics: Expert Recommendations
Andreas Iwanowitsch
STADA Arzneimittel AG , Germany
Director Medical Affairs / Corporate PV, EU QPPV
Signaling Challenges for Innovators: Portal Access and Reporting
Catrinel Popescu, DVM
Biogen, United Kingdom
Head, Safety Surveillance and Aggregate Reports