EU Directive /84/EU requires each application for Marketing Authorisation ( MA) for the EU to have a Pharmacovigilance System Master File (PSMF). EMA// Rev 2*. Guideline on good pharmacovigilance practices (GVP ). Module II – Pharmacovigilance system master file (Rev 2). 'Pharmacovigilance system master file: A detailed description of the pharmacovigilance system used by the marketing authorisation holder with.
A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with. Presented at Arena's 9th Annual Pharmacovigilance, Drug Safety and Risk Management Conference in London in November full name of qualified person responsible for the pharmacovigilance system described; list of pharmacovigilance system master files (hereinafter - PSMF) for.
Pharmacovigilance System Master File (PSMF). Date of next meeting: 7th June, Venue: Legoland Conference Centre, Windsor Cost: £ + VAT Booking: . PSMF. Pharmacovigilance System Master File. PSUR. Periodic Safety Update Report. PV. Pharmacovigilance. QPPV. Qualified Person for Pharmacovigilance. Click here to see our Pharmacovigilance system master file that fulfills the requirements of the new EU PV legislation.