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 Diagnosis and Treatment of Mental Disorders Across the Lifespan by Justina Orleans-Lindsay
Cover of the book Simulation and Modeling of Systems of Systems by Justina Orleans-Lindsay
Cover of the book Lead-free Solders by Justina Orleans-Lindsay
Cover of the book Professional SQL Server 2008 Internals and Troubleshooting by Justina Orleans-Lindsay
Cover of the book Fluid Therapy for Veterinary Technicians and Nurses by Justina Orleans-Lindsay
Cover of the book Handbook of Applied Dog Behavior and Training, Adaptation and Learning by Justina Orleans-Lindsay
Cover of the book The Evolution of Earth's Climate by Justina Orleans-Lindsay
Cover of the book The East Side: Story 1 by Justina Orleans-Lindsay
Cover of the book Measuring Health Care by Justina Orleans-Lindsay
Cover of the book Business Succession Planning For Dummies by Justina Orleans-Lindsay
Cover of the book Designing and Conducting Research in Health and Human Performance by Justina Orleans-Lindsay
Cover of the book Capitalism and Modernity by Justina Orleans-Lindsay
Cover of the book QGIS and Applications in Territorial Planning by Justina Orleans-Lindsay
Cover of the book Confrontation by Justina Orleans-Lindsay
Cover of the book Lecture Notes: General Surgery, with Wiley E-Text 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