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
Julia Cooper, PhD, is Senior Director, Worldwide Head of Medical Writing Services at PAREXEL International Ltd. Since 2002, she has been responsible for leadership of the global Medical Writing department and its outputs, including protocols, study reports, CTD/NDA and pharmacovigilance documents.
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
Schirp started his medical writing career in 1997. To date, he has covered a wide range of medical writing services, from biomedical publications and pharmacovigilance documents to global marketing applications. He is currently Head of Global Pharmacovilgilance Writing at Boehringer Ingelheim.
Swapu Banerjee, MD,MBA,MSc,FRCP (SPKNON), Deputy Managing Director, Pope Woodhead & Associates Ltd, United Kingdom
Deputy CEO at PWA, Faculty Member, Institute of Biotech, cambridge university,Consultant Surgeon ULH NHS Trust. Prev Global Drug safety Physician & Clin. Dev, Roche , Manag. Consultant McKinsey & Co.Developed multiple RMPs, REMS, and many successful filings. Author Risk management textbook, due 2013
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.