Reasons to attend
The aim of this course is to provide an overview of the Clinical Trial Regulation 536/2014 (CTR) and to allow participants to implement it in their organisation. It will allow participants to understand how the Clinical Trials Information System (CTIS) is set up, in 4 modules.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Classroom:1-Day face-to-face: 09:00 - 17:00
Online:2 webinar sessions of 3h each
The European Clinical Trial Regulation (CTR) 536/2014 is the legislation that 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. Once the CTIS is launched (planned for 31 January 2022), it will be operational and the implementation of the CTR can start. All stakeholders need to know how to work according to the new rules (CTR) and use the CTIS.
This course aims to provide an overview of mandatory CTR requirements and allow participants ready to implement them and be compliant with them.
Note: This course is not intended to go into detail about the technical aspects of the CTIS, though it will provide references where to find resources on this topic.