All studies conducted in Poland or the Netherlands must be presented to the regulatory / competent authority and an Independent Ethics Committee (IEC) for approval. The submission to the regulatory authority and ethics committee can be done in parallel according to the EU CTR Guidelines.
Our applicable IEC is the Bioethics Committee by the Regional Chamber of Physicians in Warsaw. Submissions to the IEC typically takes place 2 weeks before the scheduled meeting (3 weeks for multicenter studies). Our local IEC in Warsaw meets every 2 weeks, the replies are received within 1 week after the meeting.
Our applicable IEC in the Netherlands is the BEBO Foundation, located in Assen, the Netherlands. Within the CTR framework, the Dutch regulatory review and approval cycle for Early Phase single site studies requires between 42 and 45 days, which includes a parallel review of the intended advertisement texts. The BEBO Foundation IEC meets biweekly, and is highly specialized in Phase 1 studies. In the Netherlands, the full content review of the dossier (part I and part II) has been delegated by the Competent Authorities to the accredited IECs.
