Pharmacovigilance medical writing: a good practice guide
Useful for pharmacovigilance scientists and writers
‘Pharmacovigilance medical writing: a good practice guide’, by Justina Orleans-Lindsay. Pp xv+269. Price £34.99. Chichester: Wiley; 2012. ISBN 978 1 1199 6727 2
A great number of deaths are attributable to adverse reactions to drugs every year. Accordingly, the pharmacovigilance legislation and regulatory requirements in the EU and the US are incredibly important tools for monitoring drug safety and providing patient protection. This book aims to serve as a comprehensive reference manual covering all pharmacovigilance documents submitted to regulatory authorities in the EU and US.
After providing a background to pharmacovigilance and the drug development process, Orleans-Lindsay delves into each of the key pharmacovigilance documents in detail providing a guide to the required content and potential source data. She also details the department functions and the timelines involved. Most useful are generic templates of each document. These are laid out as the real document and each section is populated with a comprehensive description of the required content and suggested tables. The documents covered include development safety update reports, integrated summary of safety reports, risk management plans, and benefit-risk evaluations. The focus is largely on European and US regulatory requirements, but the rest of the world is also discussed in one chapter.
This book is well structured and should prove useful for pharmacovigilance scientists and writers to have a reference text and checklist for regulatory pharmacovigilance documentation requirements.
Emma McConnell is a pharmacist and an associate medical writer with a communications agency
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11116466
Recommended from Pharmaceutical Press