Pharmacovigilance Medical Writing - A Good Practice Guide
ISBN: 9781118301906
Platform/Publisher: WOL / Wiley-Blackwell
Digital rights: Users: Unlimited; Printing: Unlimited; Download: Unlimited
Subjects: Medicine; Pharmacology & Pharmaceutical Medicine;

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.

Justina Orleans-Lindsay BSc, MSc, PhD is a Director of Acadustri (Medical Writing) Limited and Visiting Lecturer in pharmacovigilance at the University of Hertfordshire, UK.


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