Pharmacovigilance Medical Writing. A Good Practice Guide. Justina Orleans-Lindsay

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Название: Pharmacovigilance Medical Writing. A Good Practice Guide

Автор: Justina Orleans-Lindsay

Издательство: John Wiley & Sons Limited

Жанр: Медицина

Серия:

isbn: 9781118302057

isbn: 0

Аннотация:

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.