Impact of the EU CTR 536/2014 on your organisation
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About this course
This course is developed for senior level people in charge of organisations who need to implement and apply the CTR. In particular the pharmaceutical industry and CRO Heads of Global Clinical Operations, Heads of Global Regulatory Sciences, Heads of Regulatory Operations, Heads of Local Regulatory Affairs, Head of Regional Clinical Operations, Heads of Academic Clinical Trial Units should attend this course.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- Course time: Webinar of 1h
Course Long Description
The European Clinical Trial Regulation (CTR) 536/2014 is the legislation which harmonises regulatory processes and information of interventional clinical trials in Europe. To meet CTR requirements, entries in the European Clinical Trials Information System (CTIS) are mandatory.
CTIS was launched on 31 January 2022, marking the entry into application of the CTR, superseding the EU Clinical Trial Directive 020/2001 (CTD). After one year of transition during which sponsors could still submit Clinical Trials under the CTD, 31 January 2023 marks the obligation to submit any new Clinical Trials according to the new rules (CTR). On 31 January 2025 all Clinical Trials in Europe will have to be run under the CTR.
Note: This course is not intended to go in details about the content of the CTR and the technical aspects of the CTIS, though it will provide references where to find resources on this topic.
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