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Glossary

Glossary of terms relating to the SCOPE Joint Action

 

  • Active Partner

    A SCOPE member who is actively contributing work to the Joint Action but is not leading any Work Packages or Topics.

  • ADRs

    Adverse Drug Reactions, unwanted or harmful reactions experienced following the administration of a drug or combination of drugs under normal conditions of use, which are suspected to be related to the drug.

  • BEMA

    Benchmarking of European Medicines Agencies.  This is a benchmarking programme among the human and veterinary medicines agencies established by the Heads of Medicines Agencyes (HMA) (Joint Human and Veterinary).

  • CHAFEA

    The Consumers, Health and Food Executive Agency is an executive Agency of the European Commission. It is responsible for initiating the SCOPE Joint Action and for providing the 70% of the funding.

  • Collaborating Partner

    A SCOPE partner from an organisation that is not a European member state. This category includes partners from research laboratories and universities; these partners are not reimbursed for the time they spend on SCOPE.

  • EAHC

    The Executive Agency for Health and Consumers, the former name for the Consumers, Health and Food Executive Agency (CHAFEA).

  • EC

    European Commission, the executive body of the European Union responsible for proposing legislation, implementing decisions, upholding the Union’s treaties and day-to-day running of the EU.

  • Evaluation

    The act of monitoring SCOPE’s progress in order to determine whether the project fulfils its aims. This will be carried out by Work Package 3.

  • Exceptional utility

    The official CHAFEA definition of the funding distribution for SCOPE, whereby the CHAFEA provides 70% of funding and the SCOPE partners provide 30%.

  • GAB

    General Advisory Board, the SCOPE executive steering committee made up of members from independent organisations.

  • IMI

    Innovative Medicines Initiative, a public-private partnership that aims to improve health throughout Europe and the world.

  • Joint Action

    A collaboration between many European Union member states, funded in part by the EAHC, with the overall aim of improving public health throughout Europe.

  • Legislation

    Laws passed that must be enacted; SCOPE has been set up in response to European pharmacovigilance legislation that was passed in June 2012.

  • MAH

    Marketing Authorisation Holder, the pharmaceutical company that holds the license for a particular drug in a particular European state.

  • MHRA

    The Medicines and Healthcare Products Regulatory Agency, the UK’s regulatory body. The MHRA is overall project coordinator for SCOPE.

  • NCAs

    National Competent Authorities, the public pharmaceutical regulatory agencies for each European member state.

  • PROTECT

    Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium, an on-going Pharmacovigilance IMI project.

  • Pharmacovigilance

    The collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

  • Quality Management Systems

    Standards which will be outlined by SCOPE to ensure that all pharmacovigilance systems across Europe meet minimum requirements. This will ensure a smooth running of all PV services, and will also enable collaboration between member states.

  • SCOPE

    Strengthening Collaboration for Operating Pharmacovigilance in Europe

  • Signal Management

    The set of activities performed to determine whether there are new risks associated with an active substance or a medicinal product. The process includes all steps from initial signal detection; through their validation and confirmation; analysis and prioritisation; and signal assessment to recommending action, as well as the tracking of the steps taken and of any recommendations made. SCOPE’s WP5 will be primarily focussed on signal management.

  • Stakeholder

    Any person or organisation what has an interest in or is affected by the processes and outcomes of a project.

  • Topic Lead

    A SCOPE partner in charge of one of the sub-topics that make up the Work Packages.

  • Work Package Lead

    A member state that is responsible for coordinating one of SCOPE’s eight Work Packages (WPs). These WPs have been established to provide clear divisions between the work that SCOPE will carry out, and each WP lead will be fully accountable for all the work that goes on in their WP.

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