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 America's Bubble Economy by Justina Orleans-Lindsay
Cover of the book Operational Excellence by Justina Orleans-Lindsay
Cover of the book Learning the City by Justina Orleans-Lindsay
Cover of the book The Geopolitics of Deep Oceans by Justina Orleans-Lindsay
Cover of the book Animal Biology and Care by Justina Orleans-Lindsay
Cover of the book CFA Level I Exam Companion by Justina Orleans-Lindsay
Cover of the book Sony vs Samsung by Justina Orleans-Lindsay
Cover of the book Alcohol-Related Violence by Justina Orleans-Lindsay
Cover of the book AutoCAD Platform Customization by Justina Orleans-Lindsay
Cover of the book Intelligent Video Surveillance Systems by Justina Orleans-Lindsay
Cover of the book Women in Culture by Justina Orleans-Lindsay
Cover of the book Japan by Justina Orleans-Lindsay
Cover of the book From the Confucian Way to Collaborative Knowledge Co-Construction by Justina Orleans-Lindsay
Cover of the book Ionic Liquids in Biotransformations and Organocatalysis by Justina Orleans-Lindsay
Cover of the book Two-Dimensional X-Ray Diffraction 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