UA-203495305-1
The EU Clinical Trial Regulation.
The EU Clinical Trial Regulation2014 No. 536 (CTR) came into force on 31 January 2022. Sponsors may now opt to undertake their clinical trials in accordance with the EU CTR.
This two 1.5 hour session course overviews the key changes brought about by the new Regulation, and considers some of the practical aspects of conducting clinical trials in accordance with the CTR.
Participants require no previous knowledge or experience of the CTR. It is most suitable for those operationally involved in clinical trial design, management and oversight, including those in clinical operations, data management, regulatory affairs and quality assurance.
The course will be interactive and involve presentations, workbook tasks, discussion, poll questions and participants Q&A.
It may be presented as two sessions in a single day with a suitable break in between, or as two sessions each on a different day.
A guide to course content is shown below, which may vary in order to keep up-to-date with changes and developments.
The course may also be delivered in-house as face-to-face training (please enquire).