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Strengthening Collaboration for Operating Pharmacovigilance in Europe [SCOPE] [20132102] - Joint Actions
General objectives

This Joint Action aims to enable coordinated pharmacovigilance operations in the EU network, making best use of worksharing and resources. A key aim is to help lower-resourced Member States develop skills and capacity in pharmacovigilance network to benefit citizens in their territory and the whole network. The Joint Action will help ensure a consistent approach across all member states for collecting information on adverse drug reactions; identifying safety issues; communicating risk and assessing risk minimisation measures all within the operation a standardised quality management system. This will benefit medicines safety monitoring and communications outputs and thereby help to safeguard public health.

Strategic relevance and contribution to the public health programme

The coordinated project will help with avoidance of duplication of resources – a key risk in the monitoring of medicines safety in the EU network.
We want to deliver sustainable outcomes for Member States which last beyond the end of the 3 year project through the creation of ongoing training materials, living documents and templates that are reviewed and adapted periodically.

Methods and means

Benchmarking of different EU systems through audit and survey work to identify best practice and weaknesses in the national pharmacovigilance systems.
Networking among EU Member States to share and document best practice through fora under different topics
Development of tools and templates to support best practice
Delivery of sustainable training in key aspects of pharmacovigilance and creating a friendly, continuing network for problem-solving

Expected outcomes period

The project will provide Member States with a "tool kit" of the basic minimum requirements for compliance in achieving effective pharmacovigilance throughout the lifecycle of a product. The deliverables will support consistent practice among Member States for proactive and transparent risk management and communication of risk.

Start date: 01/11/2013
End date: 01/11/2016
Duration: 36 month(s)
Current status: Finalised
Programme title: Second Programme of Community action in the Field of Health 2008-2013
EC Contribution: € 3 300 000,00