null Presentations from the discussion event by Fimea and Tukija on clinical trials on 18 January 2023
Presentations from the discussion event by Fimea and Tukija on clinical trials on 18 January 2023
Fimea together with National Committee on Medical Research Ethics Tukija organised a virtual discussion event targeting mandators of clinical trials, academic researchers, and research units as well as medical faculties of universities on 18 January 2023. The event covered early experiences of the CTIS portal, transitional measures and documents, the use of the CTIS portal and frequently asked questions.
Marita Kailajärvi: Experiences of using the CTIS portal, compliant with the EU Regulation 536/2014, in 2022 (pdf) (in Finnish)
Petra Nikkanen: Transitional measures (pdf) and Part II of the application, documents to be submitted to the portal (pdf) (in Finnish)
Eija Mikkonen and Mari Pirttimäki: EU CTIS portal (pdf) (in Finnish)
- Fimea: Eija Mikkonen, Clinical Trials Coordinator, eija.mikkonen(at)fimea.fi or clinicaltrials(at)fimea.fi
- Tukija: Petra Nikkanen, Lawyer, petra.nikkanen(at)tukija.fi or info(at)tukija.fi