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Pharmacovigilance Medical Writing : A Good Practice Guide by Justina Orleans-Lindsay is a nonfiction available to read on EtoBox.

What is Pharmacovigilance Medical Writing : A Good Practice Guide about?

__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.Content: Chapter 1 Pharmacovigilance Medical Writing – An Overview Across the Drug Development Process (pages 1–4): Chapter 2 Pharmacovigilance Medical Writing for Clinical Trials (pages 5–31): Chapter 3 Pharmacovigilance Medical Writing for Marketing Authorization (pages 33–74): Chapter 4 Pharmacovigilance Medical Writing in Risk Evaluation and Management (pages 75–115): Chapter 5 Pharmacovigilance Medical Writing for Marketed Products (pages 117–170): Chapter 6 The Ad?Hoc Safety Review and Response to Q

Who reads Pharmacovigilance Medical Writing : A Good Practice Guide?

Author

Justina Orleans-Lindsay

Publisher

John Wiley & Sons Inc.; Wiley-Interscience; Wiley-Blackwell

Published

2012

Language

EN

ISBN

9786613703088

Category

nonfiction

Subjects

Medical, Science, Marketing