Pharmacovigilance Medical Writing: A Good Practice Guide (repost)
Pharmacovigilance Medical Writing: A Good Practice Guide by Justina Orleans-Lindsay
English | 2012-08-13 | ISBN: 1119967260 | PDF | 286 pages | 2 MB
English | 2012-08-13 | ISBN: 1119967260 | PDF | 286 pages | 2 MB
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.