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The Strengthening Collaboration for Operating Pharmacovigilance in Europe Joint Action organised a Flagship Event on 23 November 2016 in London. The event brought together representatives from 22 national regulatory agencies, EC, EMA,  UMC, ISoP, and academia.

Over the past three years the SCOPE Joint Action gathered information, and reviewed  the pharmacovigilance practices in the network. The Flagship Event was organised to showcase SCOPE’s findings together with the tools and outputs from this unique Joint Action. The Flagship Event was a success with great contribution from all participants throughout the day. Delegates from across the Europe participated in four sessions:

Introduction to the day

Session 1 – Effective Systems for Managing ADRs and Signals

The first session was dedicated to  the SCOPE's findings and developments in the area of collection and analysis of suspected adverse drug reaction (ADR) reports and the management  of safety signals for medicines.

Developing capabilities for ADR reporting

Signal Management From implementation to operation

Session 2 - Evaluating and Maximising Risk Benefit Assessment

The next part of the meeting focused on the SCOPE achievements in  the areas of risk communication, risk benefit assessment, and quality management systems.  

Strengthening capabilities for benefit risk assessment

SCOPE risk communication tools

The importance of Quality Management Systems for PV

Session 3 - An Overview of SCOPE achievements

The third session built on the insights presented during the morning sessions and focused on maximising the potential of SCOPE's results, benefits for patients, value of the project in the pharmacovigilance network, and sustainability aspect.

Maximising the potential of SCOPE

The real benefits of SCOPE for patients

Capturing the value of SCOPE to the EU - view from the EC

EMA support to SCOPE sustainability

Session 4 – Questions and panel discussion

The panel discussion focused on maximising outputs of SCOPE Joint Action in the pharmacovigilance network and discussion about the potential further activities in the network.

Closing Remarks


Recordings and videos from the meeting will published on the website soon. 

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