Pharmacovigilance Medical Writing – A Good Practice Guide : A Good Practice Guide
Book Details
Format
Paperback / Softback
ISBN-10
1119967260
ISBN-13
9781119967262
Publisher
John Wiley and Sons Ltd
Imprint
Wiley-Blackwell
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Jul 27th, 2012
Print length
288 Pages
Weight
312 grams
Dimensions
21.60 x 13.70 x 1.30 cms
Product Classification:
PharmacologyPharmacology
Ksh 7,350.00
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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).
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.
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