Pharmacovigilance: Summary of this week’s EMA Stakehholders Meetings

Please find below, the latest information on Pharmacovigilance (PV) legislation – what has been achieved and future priorities, including a brief summary of the 10th Stakeholder forum on PV legislationthe 9th Industry Stakeholder Platform – operation of PV legislation, and the Pharmacovigilance Inspections Working Group (PhV IWG) Interested Parties’ meeting which took place on the 21st and 22nd September at the EMA in London.

The official meeting minutes and presentations will be published on the EMA website (two links above). In the meantime, please find below highlights of some of the discussed topics:

Please be reminded on the revision of the GVP (Good Vigilance Practice) modules, including an overarching introductory cover note, with considerations on biological medicinal products, which came into effect on 15th August 2016, the Guideline on GVP Product- or Population-Specific Considerations II: Biological medicinal products, as of 16th August, and in particular the public consultation of the GVP modules GVP VI Management and reporting of adverse reactions to medicinal products and GVP IX Signal Management incl. Addendum. The deadline for comments is 14th October 2016. If you have any comments on these guidelines, you can submit directly to the EMA or EUCOPE members can send contributions to EUCOPE for submission by 4th October to

The 10th Stakeholder forum on PV legislation focussed on general PV aspects, whereas technical aspects, concrete guidelines and the practical impact were mainly discussed during the 9th Industry Stakeholder Platform – operation of PV legislation.

During the panel discussion Stefan Kaehler, from Celgene kindly presented industry view on behalf of EUCOPE focussing on the quality of data.

EC report on PV

Following a presentation from the EC (Helen Lee) on the recently published 3-year report on PV activities, the EMA (Peter Arlett) was scanning the horizon drawing the big picture.


The PRAC chair (June Raine, MHRA, UK) gave an activity report from the Strengthening Collaboration for Operating Pharmacovigilance in Europe SCOPE, a project, which is running since 2013 emphasising the importance of collaboration and training.


EMA (Xavier Kurz) informed about the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium PROTECT, which is a collaborative European project that comprises a programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. Please find here the latest information published by EMA on the Protect report.


The MHRA (Philip Tregunno) presentation on mobile apps and social media for drug safety: Web-RADR initiative was harnessing mobile apps and social media for product safety.

PV impact

There will be a workshop on measuring impact of PV activities at EMA on 5th and 6th December 2016 and EMA asks for the submission on topics / questions for discussion in an interactive breakout session. We would kindly like to invite you to send your ideas to EUCOPE (

Public Hearing

The aims of public hearing, according to the legal basis Art 20 Reg 726/2004, Art 31 or 107i of Dir 2001/83/EC are to increase transparency, empower citizens, improve public understanding and add value to the assessment. The rules were set in April 2016 and are published here and EMA is ready to roll out now, having performed a successful “dry run”. At each start of a referral PRAC will consider need to hold a public hearing based on specific considerations.

PV inspections

The Interested Parties meeting with the PV inspectors working party opened the dialogue between industry, EU inspectors and the EMA. PV inspection hurdles that industry has experiences so far were addressed. Among several other aspects, the discussion focussed on a global Pharmacovigilance system master file (PSMF) and inspectors were asked on the effect in the event of including products of other regions in the PSMF. There will be further discussion on this and other aspects and industry as well as EMA and the inspectors are aware of the global applicability of PV and the need for PV convergence.

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Published on 26. September 2016 in News EU