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Session Chair(s)
Julia Cooper, PHD
Corporate Vice President, Head of Global Medical Writing Services
Parexel International, Ireland
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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