Pharmacovigilance Medical Writing —— A Good Practice Guide

----- 药物警戒医学论文写作：实用指南 第2版

ISBN: 9781119967262 出版年：2012 页码：287 Justina Orleans-Lindsay Wiley

Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.