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Good pharmacovigilance practice (GVP) guidelines. In the past the European Commission also published pharmacovigilance guidance for human medicinal products (Volume 9A). The most recent of this guidance documents dates from September 2008: Pharmacovigilance for medicinal products for human use.
12 sie 2010 · This document discusses guidelines for pharmacovigilance (PV), which is the monitoring of drugs for safety issues. Some key points: - Clinical trials must have strict ethics and safety protocols to protect subjects and maintain trust. Post-approval monitoring is also important.
Legal Basis and Structure of Volume 9A (Human Pharmacovigilance) 2. Legal Framework for Pharmacovigilance 3. The Roles of the Various Parties . PA. RT I – Guidelines for Marketing Authorisation Holders . 1. ... 2.3.9 Post-Authorisation Safety Studies_____ 30 2.3.10 Provision of Additional Data on Studies_____ 30 ...
With the application of the new pharmacovigilance legislation as of July 2012, volume 9A has now been replaced by the good-pharmacovigilance-practice (GVP) guideline, published by the Agency.
Onsite - In Conference Hotel. Online. Recording / On Demand. Top Events. Top Events. Additional Services. In-House Training Courses. E-Learning. Further Information. ... Eudralex Volume 9 Volume 9a - Guidelines on Pharmacovigilance for Medicinal Products for Human Use. Title: Eudralex Volume 9 Volume 9a - Guidelines on Pharmacovigilance for ...
Volume 9 is presented in four parts: Part I deals with pharmacovigilance of medicinal products for human use. Part II addresses pharmacovigilance of veterinary medicinal products Part III provides general information on EU electronic exchange of pharmacovigilance data.
EudraLex - Volume 9 Pharmacovigilance guidelines Volume 9 of "The rules governing medicinal products in the European Union" contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use.
