Pharmacovigilance Medical Writing

A Good Practice Guide

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Pharmacovigilance Medical Writing by Justina Orleans-Lindsay, Wiley
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: Justina Orleans-Lindsay ISBN: 9781118302064
Publisher: Wiley Publication: June 22, 2012
Imprint: Wiley-Blackwell Language: English
Author: Justina Orleans-Lindsay
ISBN: 9781118302064
Publisher: Wiley
Publication: June 22, 2012
Imprint: Wiley-Blackwell
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from Wiley

Cover of the book Banks at Risk by Justina Orleans-Lindsay
Cover of the book World History For Dummies by Justina Orleans-Lindsay
Cover of the book Social Network Analysis with Applications by Justina Orleans-Lindsay
Cover of the book Green Aviation by Justina Orleans-Lindsay
Cover of the book Fundamentals of Biophysics by Justina Orleans-Lindsay
Cover of the book The Public Relations Writer's Handbook by Justina Orleans-Lindsay
Cover of the book Basic English Grammar For Dummies - US by Justina Orleans-Lindsay
Cover of the book Labor, Economy, and Society by Justina Orleans-Lindsay
Cover of the book Software Specification Methods by Justina Orleans-Lindsay
Cover of the book 52 Weeks of Sales Success by Justina Orleans-Lindsay
Cover of the book High Performance Polymers and Their Nanocomposites by Justina Orleans-Lindsay
Cover of the book Go Mobile by Justina Orleans-Lindsay
Cover of the book Bayesian Inference in the Social Sciences by Justina Orleans-Lindsay
Cover of the book Launching and Leading Change Initiatives in Health Care Organizations by Justina Orleans-Lindsay
Cover of the book Windows 8.1 For Dummies by Justina Orleans-Lindsay
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy