Pharmacovigilance Medical Writing (Paperback) (ISBN-13: 9781119967262)

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.

Author: Justina Orleans-Lindsay
ISBN-10: 1119967260
ISBN-13: 9781119967262
Publisher: Wiley-Blackwell
Language: English
Published: 08/13/2012
Pages: 288
Format: Paperback
Weight: 0.65lbs
Size: 8.40h x 5.40w x 0.50d