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The Strengthening Collaborations for Operating Pharmacovigilance in Europe (SCOPE) Joint Action Stakeholder Event took place on 20-21 March 2017 in London. The event brought together SCOPE’s key stakeholders from National Competent Authorities, patient organisations, healthcare professionals, pharmaceutical industry and academia.

The event provided an opportunity to raise awareness of the Joint Action and over the two event days, participants discussed SCOPE Joint Action’s outputs and further tested and explored the project’s findings. There was an open forum for the exchange of views and ideas for building on SCOPE to develop pharmacovigilance.


Day 1 - Monday 20 March 2017:

Welcome, Georgios Margetidis (CHAFEA)

An overview of SCOPE and its achievements, June Raine (MHRA)


Session 1 – SCOPE Work Package overviews

Developing capabilities for ADR reporting, Marina Lesičar (HALMED)

Signal management from implementation to operation, Daniel Zondag (MEB)

Risk communication - analysis of tools, Dolores Montero (AEMPS)

The importance of quality management systems for PV, Julia Pallos (OGYÉI)

Strengthening capabilities for benefit risk assessment, Jelena Ivanovic (AIFA)


Session 2 – SCOPE from three perspectives

Collaboration to promote and support ADR reporting and feedback to patients, François Hoyuez (EURORDIS)

HCPs’ perspective on safety communication about medicines - What have we learnt from SCOPE? Peter Mol (University of Groningen)

Benefit and harm information, Theo Raynor (University of Leeds)


Day 2 - Tuesday 21 March 2017:

Session 1 - Building on SCOPE

Working together and building on SCOPE to develop PV further, Helen Lee (EC)

Introduction to discussion session, Mick Foy (MHRA)

Table discussions focused on the below four questions:

- What can we do to further strengthen ADR reporting?

- How can we improve getting relevant safety information to patients?

- How we can enhance reaching healthcare professionals with timely safety information/advice?

- How will SCOPE materials help to support consistent high standards in PV assessment capabilities/ benefit and harm assessment?

Inital outputs from the table discussions can be found here.


Session 2 – SCOPE selected special topics of interest

Participants were able choose which special selected topics to attend. Topics B were of more interest/relevance to industry and regulatory delegates.


Topics A

Topic 1A: WP5 signal management overview for patients (and HCPs), Pilar Rayon (AEMPS)

Topic 2A: WP6 patient consultation results, Anna Marie Coleman (HPA)

Topic 3A: WP6 key actions for national implementation of risk communication strategy, Yvette Escudero (AEMPS)

Topic 4A: WP4 tools for measuring and improving quality of reports in national ADR databases, Adriana Andrić & Petar Mas (HALMED)

Topic 5A: WP4 ADR campaigns and measuring, Mitul Jadeja (MHRA)

Topics B

Topic 1B: WP8 SCOPE’s work in relation to referrals, Alison Shaw (MHRA)

Topic 2B: WP7 introduction to quality management systems, Inma Corrales (AEMPS)

Topic 3B: WP4 duplicate detection Part 1, Katarina Gvozdanović (HALMED) & Part 2, Phil Tregunno (MHRA)

Topic 4B: WP5 best practice signal management - highlights for industry, Phil Tregunno (MHRA)

Topic 5B: WP4 medication errors, Željana Margan Koletić (HALMED)

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