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NEW EU PHARMACOVIGILANCE LEGISLATION AND THE IMPACT ON MEDICAL INFORMATION
Session Chair(s)
Janet Davies
Senior Director, Medical Information
Gilead Sciences, United Kingdom
The new Pharmacovigilance legislation has been said to represent the biggest change in pharmaceutical legislation since 1995, or even longer. This session will look at the impact of these changes and explore how medical information is rising to the challenges of implementation. There are uncertainties relating to off-label questions and analysis of medical information requests for PSURs. The increased access to safety information may result in increased volumes of questions to medical information departments. The session will explore the practical challenges and experiences of implementing the legislation.
Speaker(s)
Impact of the Revised Legislation on Regulatory Communications
Niamh C Arthur, BSN
Irish Medicines Board, Ireland
Pharmacovigilance Manager
Points to Consider when Implementing EU Pharmacovigilance (PV) Legislation in Medical Information
Sarah Hall, PhD
Takeda UK Ltd, United Kingdom
Medical Info & Pharmacovigilance Manager
Practical Experience in Implementing EU Pharmacovigilance (PV) Legislation in Medical Information
Monika Benker
Bristol-Myers Squibb, Germany
Lead Medical Capabilities Germany
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