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SCOPE Joint Action

The Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action was aimed to help medicine regulators operate pharmacovigilance systems to the EU legislative requirements. Regulators have worked together to improve the skills and capability in the pharmacovigilance network to help safeguard public health in both national territories and the EU as a whole.

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Latest news:

SCOPE open access article published in Drug Safety

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Work Packages

Work Package 1 – Governance

Lead: Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Work package 1 delivers the coordination and project management functions for SCOPE

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Work Package 2 - Dissemination

Lead: Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

This work package aims to effectively disseminate information about SCOPE and its deliverables

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Work Package 3 – Evaluation

Lead: National Authority of Medicines and Health Products, I.P. (INFARMED), Portugal

This work package focusses on the evaluation of SCOPE to verify that the project is delivers what was planned to achieve the objectives

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Work Package 4 – ADR collection

Lead: Agency for Medicinal Products and Medical Devices (HALMED), Croatia

This work package focuses on national adverse drug reaction reporting schemes, including patient reporting and efforts to improve awareness of national systems

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Work Package 5 – Signal Management

Lead: Medicines Evaluation Board (MEB), Netherlands

This work package examines signal management at the level of the National Competent Agencies

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Work Package 6 – Risk Communications

Lead: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Spain

This work package focusses on risk communications about medicines, including communications tools and channels and their effectiveness

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Work Package 7 – Quality Management Systems

Lead: National Institute of Pharmacy and Nutrition (OGYÉI), Hungary

This work package aims to support quality standards in pharmacovigilance systems

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Work Package 8 – Lifecycle Pharmacovigilance

Lead: Agenzia Italiana Del Farmaco (AIFA), Italy

The final work package examines aspects of pharmacovigilance assessment including assessor competency

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SCOPE is funded by the Health
Programme of the European Union
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