WebOct 17, 2024 · Overview. The Clinical Trials Information System (CTIS) is the single-entry point for clinical trials authorisation and supervision in the EEA. This includes a single clinical trial application dossier, covering clinical trial applications submitted to EU/EEA Member States, including submission to National Competent Authorities (NCAs) and Ethics … WebMar 31, 2024 · The Clinical Trials Regulation requires all information stored in the CTIS database to be publicly available, unless exempted to protect the following:. Personal data; Commercially confidential information (in particular the marketing-authorisation status of a medicine, unless there is an overriding public interest); Confidential communication …
CTIS highlights newsletter - Issue 2, December 2024
WebCTIS provides a harmonised and simplified end-to-end electronic application procedures over the life-cycle of clinical trials across the EU/EEA. CTIS is, however, not a clinical trial management system. It should therefore not be relied upon by sponsors to store information on a clinical trial. Although CTIS provides a digital secured archive of WebAug 2, 2024 · The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for the Clinical Trials Information System (CTIS) will be on 31 January 2024.. As set out in the Clinical Trials Regulation, the entry into application of that Regulation is set by the publication of a notice in the Official … customize your own car air freshener
Clinical Trials Information System European Medicines …
WebSep 16, 2024 · Clinical Trials Information System (CTIS) will act as the single entry point for clinical trials authorisation and supervision in the EEA. CTIS was created as part of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014).. This EMA hosted webinar is open to all sponsor organisations, including pharmaceutical companies, contract … WebCTIS project. From August 2024 he is head of EMA TDA Data analytics and Methods Taskforce clinical workstream and CTIS programme manager.!! CLINICAL TRIALS INFORMATION SYSTEM (CTIS) SEMINAR Panhellenic Assocation of Pharmacists … WebJan 31, 2024 · The application of the European Union Clinical Trials Regulation (EU CTR) and Clinical Trials Information System (CTIS) on 31 January 2024 will result in considerable changes to the way clinical trials are conducted in the EU. Specifically, the CTIS will serve as a single entry point for clinical trial information in the EU and the European ... customize your own case