DIA 2013 49th Annual Meeting
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The New European Pharmacovigilance Legislation: Guiding Medical Writers Through the Risks and Benefits
Track : Track 06: Medical Communication, Medical Writing and Medical Science Liaison
Program Code: 249
Date: Tuesday, June 25, 2013
Time: 1:45 PM to 3:15 PM  EST
Location: 204AB
CHAIR :
 Julia Cooper, PhD (SCHNON), Senior Director, Worldwide Head of Medical Writing Services, PAREXEL International Ltd., United Kingdom
SPEAKER (S):
Julia Cooper, PhD (SCHNON), Senior Director, Worldwide Head of Medical Writing Services, PAREXEL International Ltd., United Kingdom
 Sven Schirp, (SPKNON), Head of Global Pharmacovigilance Writing, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany
 Swapu Banerjee, MD,MBA,MSc,FRCP (SPKNON), Deputy Managing Director, Pope Woodhead & Associates Ltd, United Kingdom
Description
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.