Pharmacovigilance Medical Writing
Author | : Justina Orleans-Lindsay |
Publisher | : John Wiley & Sons |
Total Pages | : 182 |
Release | : 2012-06-22 |
ISBN-10 | : 9781118302064 |
ISBN-13 | : 1118302060 |
Rating | : 4/5 (060 Downloads) |
Download or read book Pharmacovigilance Medical Writing written by Justina Orleans-Lindsay and published by John Wiley & Sons. This book was released on 2012-06-22 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.