Pharmacovigilance Medical Writing for Marketed Products

Jul 23, 2016 by in PHARMACY Comments Off on Pharmacovigilance Medical Writing for Marketed Products

5.1 Introduction Once a medicinal product has been approved for marketing, the marketing authorization holder (MAH) has an obligation to periodically submit a number of pharmacovigilance reports to relevant regulatory…

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The ad-hoc Safety Review and Response to Questions Document

Jul 23, 2016 by in PHARMACY Comments Off on The ad-hoc Safety Review and Response to Questions Document

6.1 Introduction In addition to the multiplicity of mandated periodic pharmacovigilance documents required for investigational and authorized medicinal products, documents submitted at the time of application for marketing authorization, and…

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The Rest of the World

Jul 23, 2016 by in PHARMACY Comments Off on The Rest of the World

7.1 Introduction For obvious reasons, the main preoccupation of this volume has been to focus on pharmacovigilance medical writing as it is practiced in the EU and US. It would…

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