Understanding and complying with the EU CTR - ECCRT
  /    /  Understanding and complying with the EU CTR

Understanding and complying with the EU CTR

Book a session

DateProductLocationPrice 
28/02/2023Understanding and complying with the EU CTRBrusselsEUR 850.00Book
23/05/2023Understanding and complying with the EU CTRWebinarEUR 850.00Book
05/10/2023Understanding and complying with the EU CTRBrusselsEUR 850.00Book
12/12/2023Understanding and complying with the EU CTRWebinarEUR 850.00Book
If you would like to have this course as an in-house session click here
Implementing EU CTR 536 training - ECCRT

About this course

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.

What's included?

  • Documents and materials related to this course are included
  • Globally recognised certificates awarded after test completion
  • This course has been granted PharmaTrain Recognition

Course schedule

Classroom:

1-Day face-to-face: 09:00 - 17:00

Online:

2 webinar sessions of 3h each


Course Description

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.

User registration

Reset Password