Fimea to host a number of pharmaceutical meetings during Finland's Presidency
The Finnish Medicines Agency Fimea will arrange several meetings for the European medicines regulatory network during Finland’s Presidency of the Council of the EU. The heads of EU Member States’ medicines agencies will convene in Helsinki, along with representatives of scientific committees and workgroups from different national agencies together with the representatives of the European Medicines Agency and the European Commission. Around 800 experts in the pharmaceutical industry are expected to attend the meetings that will be held during the autumn.
Fimea will arrange two meetings of Directors-General of the EU/EEA as well as six other meetings with participants from 14 different committees or scientific working groups attending them. Fimea will also participate in the preparation of the agendas of many other meetings arranged by other government agencies or the Ministry of Social Affairs and Health. Additionally, pharmaceutical matters will also be discussed in September at the meeting of pharmacopolitical directors arranged by the Ministry of Social Affairs and Health in Helsinki, and at the Member States’ informal meeting held in Brussels.
Finland seeks to actively influence the agendas of the meeting arranged during its Presidency
In Fimea’s meetings, the themes raised will include innovations and new medicines, rational pharmacotherapy and the availability of medicines, and making EU’s joint processes more effective. Fimea will prepare and promote its themes in collaboration with its own committee representatives, pharmaceutical officials from the Ministry of Social Affairs and Health, and the pharmaceutical representatives of the EU Delegation in Brussels.
Additionally, discussions will be conducted on other topics already underway in the EU, such as the implementation of regulations concerning clinical trials and veterinary medicines, the assessment of the effectiveness of the marketing authorisation system as well as several initiatives to promote the availability of medicines. The foreseen preparation of the joint strategy of the European Medicines Agency and the Heads of Medicines Agencies (HMA) network for 2025 will also take place during the Presidency. Further challenges to the entire pharmaceutical industry will by posed by the Brexit if it happens on 1 November 2019.
Furthermore, Finland also has interesting and unique national examples to present for the EU medicines regulatory network, such as the National Medicines Information Network and Medicines Information Strategy, the Medicines Education Portal, and the Meds75+ databases.
First meeting in July
Held in July, the first scientific INNO joint meeting will bring together the Scientific Advice Working Party (SAWP) of the European Medicines Agency, the European Network for Health Technology Assessment (EUnetHTA), the Clinical Trials Facilitation and Coordination Group (CTFG), and the EU Innovation Network.
In the July meeting, these working groups will convene for the first time simultaneously. The meeting agenda will include review of the processes for scientific advice given by different groups and mapping out of opportunities for collaboration, the scientific and regulatory challenges currently faced in the provision of advice, the horizon scanning of future challenges, the numerous ongoing development projects pursued by the authorities, and discussion on the demonstration of efficacy and safety in situations where such information is very limited upon issuance of a marketing authorisation (e.g. a conditional marketing authorisation).
In the meeting, Finland’s objective is to promote more diverse discussion and information sharing about innovations and new medicines. Dialogue and tightening of cooperation between medicinal authorities and HTA bodies are important when the objective is that innovative medicines are made available to the patients on a timely basis based on sufficient research evidence.
Finland’s Presidency of the Council of the European Union website
MSAH’s Presidency of the Council of the European Union website
Fimea’s Presidency of the Council of the European Union website
- Eija Pelkonen, Director-General, tel. +358 29 522 3100
- Esa Heinonen, Director, Assessment of Medicinal Products, tel. +358 29 522 3310
- Pertti Happonen, Director, Assessment of Pharmacotherapies, tel. +358 29 522 3500
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