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SRLM Meeting of EMA's Committee for Orphan Medicinal Products (COMP) hosted by HALMED


Strategic Review and Learning Meeting (SRLM) of the Committee for Orphan Medicinal Products (COMP) started today at the Hotel International in Zagreb. The meeting of this important European Medicines Agency’s committee, taking place from 12 to 14 February 2020, is organised by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED), under the auspices of the Croatian Presidency of the Council of the European Union.

The meeting was officially opened by Mr Željko Plazonić, MD, PhD, State Secretary of the Croatian Ministry of Health, who noted it was an extraordinary honour to participate in the Committee’s meeting, whereby thanking HALMED "for gathering experts whose work is on a daily basis aimed at the development of therapy for treating rare diseases". He also noted that, with its National Program for Rare Diseases, the Croatian Ministry of Health has encompassed a number of strategic issues, including education and prevention, early identification of rare diseases and researches necessary for development of new medicinal products, as well as for ensuring increasingly needed individual therapies.

Prof Siniša Tomić, PhD, Head of HALMED, welcomed the meeting participants, highlighting it was a privilege to host this meeting primarily for COMP’s role and great importance it represents for 30 million of patients with rare diseases across the European Union. Furthermore, Prof Tomić congratulated the Committee on its 20 years of successful work, during which many milestones in ensuring therapeutic options for rare diseases were achieved, thanks to the indispensable role of COMP and EMA.

Violeta Stoyanova-Beninska, MD, PhD, MPH, Committee Chair, expressed her gratitude to HALMED for hosting the meeting, underlining two important opportunities Strategic and Learning Meetings provide: "The first is that members can obtain some knowledge on the health care system of the country of one of their colleagues, and the second is that during these meetings members can meet in a different environment and dedicate some time to discuss overarching issues which are important for the work of the Committee."

Croatian Committee member, Prof Dinko Vitezić, PhD, from the Faculty of Medicine of the University of Rijeka, emphasised the strategic importance of this meeting, marking it an excellent opportunity for reaching conclusions on further development of the Committee’s work.

Alongside the delegates from the EU and Member States medicines regulatory bodies, the meeting is also attended by the representatives of relevant Croatian institutions in this field; Ministry of Health, Croatian Health Insurance Fund, HALMED and the University of Zagreb Medical School.

The meeting covers a number of expert topics, including the development of orphan medicinal products and research on new medicinal products. Moreover, the possibilities of treating rare diseases in Croatia and the availability of orphan medicinal products through the Croatian Health Insurance Fund (HZZO) will be presented. In addition, the attending experts will discuss current issues in the field of determining medical conditions and satisfactory methods of treatment, as well as the effects of regulatory authorities’ initiatives and programs in developing new medicinal products and enhancing access to therapies for patients with rare diseases.

COMP is the European Medicines Agency's (EMA) committee responsible for recommending orphan designation of medicines for rare diseases in the EU. By assigning an "orphan" status to a medicinal product, the development and marketing of these medicinal products are encouraged, while increasing the availability of these medicinal products to patients. The COMP also advises and assists the European Commission on matters related to orphan medicines, including developing and establishing an EU-wide policy, drawing up detailed guidelines and liaising internationally.

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SRLM Meeting of EMA's Committee for Orphan Medicinal Products (COMP) hosted by HALMED