Several scientific committees and working groups convened in Helsinki in November

Fimea hosted a number of meetings of the scientific committees the European medicines regulatory network in Helsinki during Finland’s EU Presidency.

Fimea and the Finnish Food Authority hosted jointly the WGEO meeting held in Helsinki

The Working Group of Enforcement Officers (WGEO) is a working group subordinate to the European Heads of Medicines Agencies (HMA) that, in addition to the representatives of medicines agencies and food safety authorities, includes representatives of the police and the customs as its members. The working group focused on the illegal manufacture, distribution and sale of medicines on the Internet, other pharmaceutical industry, phenomena and threats related to falsified medicines, and illegalities activities related to veterinary medicines.

The working group convened on 10–13 November 2019 in Helsinki for a meeting during Finland’s Presidency that was jointly arranged by Fimea and the Finnish Food Authority. The meeting was attended by nearly 100 participants.

The three-day meetings ended with a practical exercise that addressed the communication of risks in different example cases.

Further information:

Sami Paaskoski, Senior Pharmaceutical Inspector, Fimea, tel. +358 29 522 3237
Henrietta Helin, Finnish Food Authority, henrietta.helin-soilevaara@ruokavirasto.fi

IT directors and CMDh in a joint meeting

The joint meeting of IT directors and the Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) was arranged on 18–20 November 2019. The meeting was attended by some 85 participants.

The IT directors’ agenda included, in particular, the future strategy of the European medicines regulatory network and its prerequisites for IT. The meeting addressed the ongoing IT system projects, such as electronic product information (ePI), and planned new upcoming projects for the needs of the new veterinary legislation and clinical trials, among other things.

The section dedicated to CMDh addressed themes related to availability, medical devices and biosimilars, among other things, as well as the Meds75+ database presented by Fimea.

Further information:

IT directors:
Jaakko Hartikka, ICT Manager, tel. +358 29 522 3619

CMDh:
Pauliina Ikäheimo, Senior Medical Officer, tel. +358 29 522 3334
Päivi Jutila, Coordinator for Marketing Authorisations, tel. +358 29 522 3365

Orphan medicinal products, paediatric medicines and ATMP products discussed in a joint meeting

The European Medicines Agency’s (EMA) Paediatric Committee (PDCO), Committee for Orphan Medicinal Products (COMP) and Committee for Advanced Therapies (CAT) convened in a strategic joint meeting during Finland’s Presidency on 20–22 November 2019.

The objective was to gain a deeper insight into the work of the different committees and to discuss the common challenges faced in the evaluation and market entry of orphan medicinal products, paediatric medicines and advanced therapy products. The meeting also heard presentations on the availability of such medicines in the Nordic countries and in different EU Member States.

Additionally, the Paediatric Committee visited the New Children’s Hospital and was presented with its children- and family-friendly practices as part of its own meeting programme.

Further information:

PDCO:
Ann Marie Tötterman, Senior Researcher, tel. +358 29 522 3351
Pia Annunen, Senior Medical Officer, tel. +358 29 522 3460

COMP:
Karri Penttilä, Senior Medical Officer, tel. +358 29 522 3420
Johanna Lähteenvuo, Senior Medical Officer, tel. +358 29 522 3457

CAT:
Heli Suila, Senior Researcher, tel. +358 29 522 3019
Olli Tenhunen, Senior Medical Officer, tel. +358 29 522 3462

The EU Heads of Medicines Agencies convened in their HMA II meeting

The EU Heads of Medicines Agencies (HMA) convened on 27–29 November in Levi, Kittilä, for the second HMA meeting held during Finland’s presidency of the Council of the EU.

The agenda included, among other things, the strategy of the network, the availability of medicines, Brexit as well as other matters of current interest concerning medicines, such as big data and the preparation of the common electronic package leaflet. The Medicines Education Portal and the Meds75+ database were addressed as themes raised by Finland. In addition to the heads of medicines agencies, the meeting participants included management representatives from the European Medicines Agency and representatives of the European Commission.

Further information:

Eija Pelkonen, Director-General, tel. +358 29 522 3100
Esa Heinonen, Director, tel. +358 29 522 3310

E-mail address format: firstname.lastname@fimea.fi