News and Educations

HALMED to host meetings of committees and working groups during the Croatian Presidency of the EU Council

07.01.2020

As part of the Croatian Presidency of the Council of the European Union from 1 January to 30 June 2020, Agency for Medicinal Products and Medical Devices of Croatia (HALMED) will host a series of meetings regarding scientific committees and working groups in the field of medicinal products and medical devices.

By organising meetings and participating in the work of committees and working groups during the Croatian Presidency, HALMED will support a continuity of the EU regulatory network. At the same time, as a host, HALMED will continue to promote the positive international image of Croatia.

During the Croatian Presidency, HALMED will host seven meetings in total, which will be held in Zagreb, Split and Dubrovnik:

  • Committee for Orphan Medicinal Products (COMP), 12 - 14 February 2020, Zagreb
  • The 99th Heads of Medicines Agencies (HMA) meeting, 4 - 6 March 2020, Zagreb
  • Competent Authorities for Medical Devices (CAMD), 16 - 18 March 2020, Zagreb
  • The Committee for Medicinal Products for Human Use (CHMP) and Scientific Advice Working Party (SAWP) joint meeting, 7 - 9 April 2020, Dubrovnik
  • The Pharmacovigilance and Risk Assessment Committee (PRAC) and Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) joint meeting, 22 - 24 April 2020, Split
  • The 100th Heads of Medicines Agencies (HMA) meeting, 27 - 29 May 2020, Split
  • Working Group of Quality Managers (WGQM), 8 - 10 June 2020, Zagreb

Moreover, additional six meetings of committees and working groups from HALMED's area of jurisdiction will be held under the Croatian Presidency sponsorship, organized by regulatory authorities of other EU Member States and the European Medicines Agency (EMA).

Apart from the stated meetings, HALMED's representatives who are members of the expert team will be involved in the activities of the Working party for medicinal products and medical devices, whose meetings are regularly held in Brussels.

During the presidency, HALMED's experts will participate in the preparation and alignment of working programme and meeting agendas for committees and working groups, with an opportunity to represent topics that are particularly important to the regulation and monitoring of the safety of medicinal products and medical devices, as well as topics that are important to ensuring available, quality and safe medicinal products and medical devices, in order to protect public health.

Therefore, the meeting schedules will comprehend a number of important topics such as: availability of medicinal products, benchmarking programme of the EU medicines agencies, implementation status of the new regulation for medical devices, principles of good pharmacovigilance practice in a contest of risk minimization measures, integration of data received from epidemiological databases into the procedures regarding drug safety at the EU level, appliance of digital devices regarding health and the use of Big Data in the field of medicinal products and healthcare. Additionally, other current topics discussed at the EU level will be covered during the Croatian Presidency, including clinical trials regulation, veterinary medical devices, orphan medicinal products, the Brexit impact on the regulatory medicinal products and medical devices system, as well as other strategic issues related to the work of each committee and working group.

The most important strategic meetings in the field of medicinal products that HALMED will host during the Croatian Presidency of the Council of the European Union are the ones of the Heads of Medicines Agencies (HMA). HMA gathers the directors of all Member States’ Agencies twice during each Presidency, in order to make crucial decisions regarding patients’ health and public health issues within the EU. Through their joint activities, harmonized work at the EU level is achieved and mutual cooperation between the EU Member States is carried out regarding control and monitoring of the safety of medicinal products usage, as well as ensuring that appropriate therapy is available for patients. During the Croatian Presidency, preparation of a joint strategy of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) for the 2020-2025 will take place.

All news related to HALMED's activities during the Croatian Presidency will be regularly published on the HALMED's website under the News an educations and the Croatian Presidency of the Council of the European Union section, as well as on the official website of the Croatian Presidency where all information related to the Croatian presidency and the upcoming meetings will be provided.

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