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The New European Pharmacovigilance Legislation: Guiding Medical Writers Through the Risks and Benefits
Session Chair(s)
Julia Cooper, PhD
Corporate Vice President, Head of Global Medical Writing Services
Parexel International, Ireland
This session reviews practical experience of the new European Union pharmacovigilance legislation as it relates to medical writers preparing periodic safety update reports, risk management plans and documents for postauthorization safety studies.
Learning Objective : Describe the changes introduced by the new European pharmacovigilance legislation as they relate to medical writers; Discuss best practice in utilizing the modular approach to PSURs, DSURs and RMPs; Illustrate examples of different approaches to writing the new structured benefit-risk evaluation.
Speaker(s)
The Periodic Benefit-Risk Evaluation Report (PBRER): A Practical Guide for Medical Writers
Julia Cooper, PhD
Parexel International, Ireland
Corporate Vice President, Head of Global Medical Writing Services
Three Reports – One Story: Managing the DSUR, PBRER and the RMP
Sven Schirp
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Head of Global Pharmacovigilance Writing
Navigating Module VIII: Post Authorization Safety Studies
Swapu Banerjee, MD, MBA, MSc, FRCP
Pope Woodhead & Associates Ltd, United Kingdom
Deputy Managing Director
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