Pharmacovigilance Conference

The EU PSMF is widely considered by Industry as being a comprehensive and useful tool for PV oversight. This has come about following a period of ‘embedding’ during which the scope and interpretation of the legislation by companies and EU regulators has undergone much discussion and resolution. With the global awakening of pharmacovigilance regulations and the increasing global adoption of GVP-based legislation, it is a sincere wish from industry that the procedures already set up to fulfil the EU requirements for a PSMF can be easily adapted to suit global requirements. If non-EU regulators are willing and able to embrace the learnings gained since the 2012 release of the EU GVP and adopt a pragmatic approach to their local or regional PSMF requirements this will allow precious resource to be focussed on value-adding activities. A small group of industry PSMF experts conducted a survey of non-EU PSMF experience last year and an update on the survey results will be presented along with a lively discussion of the known ‘pain points’ in PSMF preparation. A speaker from a non-EU region will also provide a candid and detailed account of managing the PSMF and regulatory interactions in their region. Delegates are encouraged to come with thoughts on what areas of GVP II may be more suitably adapted to create a global PSMF concept as opposed to a purely EU concept.