Pharmacovigilance Medical Writing. A Good Practice Guide - Justina Orleans-Lindsay
| Автор: | Justina Orleans-Lindsay |
| Издательство: | John Wiley & Sons Limited |
| Серия: | |
| Жанр произведения: | Медицина |
| Год издания: | 0 |
| isbn: | 9781118302057 |
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.