The EU Directive 2010/84/EU (amending 2001/83/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.
Any company that has at least one pharmaceutical product approved in the European Union is therefore required to have a PSMF in place.
The PSMF gives regulators a complete description and assessment of the full pharmacovigilance system, and the annexes' outputs help them determine how well a company is complying.
To ensure compliance, this training will provide a practical guidance to developing, drafting, maintaining, and updating the PSMF.
The sessions will also discuss the PSMF's importance in regulatory inspections, as well as common PSMF inspection findings.