Pharmacovigilance Medical Writing. A Good Practice Guide

Justina Orleans-Lindsay

Тип: PDF книга

Жанр: Фармакология

Язык: на английском языке

Издательство: John Wiley & Sons Limited

Дата публикации: 25.04.2024

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О книге: 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.