Pharmacovigilance Medical Writing

Pharmacovigilance Medical Writing

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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.A Good Practice Guide Justina Orleans-Lindsay. Element ... REMS Report Data Source Package Insert Medication Guide/ Drug Safety (Pharmacovigilance)/ Regulatory Affairs Communication Plan Drug Safety (Pharmacovigilance)/ Regulatoryanbsp;...

Title:Pharmacovigilance Medical Writing
Author: Justina Orleans-Lindsay
Publisher:John Wiley & Sons - 2012-06-22

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