Pharmacovigilance Medical Writing

Beschreibung

Pharmacovigilance Medical Writing covers thepreparation of pharmacovigilance documents for all stages of thedrug development process (i.e. from clinical development through toapplications for marketing authorisations to the post-marketingstage). For each document, the book presents a review of theregulatory 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 ageneric model document compliant with the current guidelines, whichcan be modified to meet specific company and product requirements.

Autor*in

Justina Orleans-Lindsay

Themen in »Pharmacovigilance Medical Writing«

Arzneimittelüberwachung Clinical Pharmacology & Therapeutics Klinische Pharmakologie u. Therapie Medical Science Medizin

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"This book is well structured and should prove useful forpharmacovigilance scientists and writers to have a reference textand checklist for regulatory pharmacovigilance documentationrequirements." (Pharmaceutical Journal, 9February 2013)
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