28 Mar EMA// Rev 2*. Guideline on good pharmacovigilance practices (GVP ). Module II – Pharmacovigilance system master file (Rev 2). 19 Apr 'Pharmacovigilance system master file: A detailed description of the pharmacovigilance system used by the marketing authorisation holder with. EU Directive /84/EU (amending /83/EC) requires each application for Marketing Authorisation (MA) for the EU to have a Pharmacovigilance System Master File (PSMF) in place including the named Qualified Person responsible for Pharmacovigilance within the EEA.
6 Nov Presented at Arena's 9th Annual Pharmacovigilance, Drug Safety and Risk Management Conference in London in November A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with. full name of qualified person responsible for the pharmacovigilance system described; list of pharmacovigilance system master files (hereinafter - PSMF) for.
As of July , every marketing authorization holders (MAH) is required to have a Pharmacovigilance System Master File (PSMF) which is a paper or electronic. 27 Mar - 19 min - Uploaded by emainfo Pharmacovigilance system master file: An approach towards system forum on the. PSMF. Pharmacovigilance System Master File. PSUR. Periodic Safety Update Report. PV. Pharmacovigilance. QPPV. Qualified Person for Pharmacovigilance. 6 Feb News - Learn more about the Pharmacovigilance System Master File or PSMF. 8 Jul Derek Woodcock gives an overview of the Pharmacovigilance System Master File in our safety and pharmacovigilance themed month.