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Aims

SCOPE has six high level objectives which are:

    • 1

      SCOPE will enable Member States to develop a fuller understanding of, and develop best practice in, reporting mechanisms for adverse drug reactions. This will be achieved by supporting development of national reporting schemes with a focus on reporting by patients and reports of special interest, surveys of member states to gather data on ADR reporting to identify best practice and recommend minimum standards & tools within 3 years.

    • 2

      Implementing shared understanding of best practice in signal management across the EU network. SCOPE will document and deliver within three years recommendations for consistent and timely procedures for the timely detection, management and assessment of safety signals across the EU network. There is a focus on signals of special interest and medication error.

    • 3

      To define best practice in Risk Communications through the creation of a standardised toolkit. To implement solutions for communication between member states on public transparency approaches, and to coordinate the presentation of information to the public around the EU network such that citizens are able to access all public information relating to a drug.

    • 4

      Enabling Member States to develop, understand and assess their quality management systems for pharmacovigilance. SCOPE will define minimum requirements for pharmacovigilance system operation, standards which can be built upon to enhance the pharmacovigilance capacity of a member state in particular areas by creating an understanding of resources required.

    • 5

      Developing a competency framework to support exemplary pharmacovigilance throughout the product lifecycle. The Joint Action will define core standards for benefit-risk assessment of products throughout their lifecycle, including development of best practice and establishing minimum competencies for management and assessment, and measuring effectiveness of risk minimisation.

    • 6

      To create a forum for interaction amongst European National Competent Authorities to strengthen regulatory collaboration. This will lead to improved understanding of the different challenges faced by member states. SCOPE will seek a collaborative approach to developing solutions to these challenges, enabling national competent authority staff to work more closely together to strengthen the European and global pharmacovigilance network.

SCOPE is developing recommendations, guidance and training for regulators to support the EU pharmacovigilance network
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