EU Clinical Trial Regulation

CTR Newsletters

FAMHP would like to inform you that, as announced during their second CTR info session, the clinical trials page of the FAMHP website has been revised in order to provide the information on the CTR implementation and on the transition period.

A news has been published on the FAMHP website to announce the CTR go life.

Please consult this news in English here. The Dutch and French versions are also available on the corresponding pages.

Please find also here below the following information related to the Clinical Trials Information System, CTIS :  

  • In relation to the need and urgency for access to CTIS Sandbox as of wave 3 a second survey slot (Survey 2.0) is open since 25 January 2022 until 31 March 2022 to allow additional interest to be expressed by those not in a position to respond on Survey 1.0. Currently no decision has been taken on whether additional access (wave 3, phase 2 etc) to the CTIS Sandbox will be granted. To inform that decision, EMA will use remaining expressions of interest from Survey 1.0 and any additional expressions of interest from Survey 2.0
  • In 2022, EMA offers short talks for clinical trial sponsors focussed on CTIS functionalities.

Each bitesize talk will include a short demonstration of a CTIS functionality, such as user role management and the initial clinical trial application, and will provide ample time for sponsors to ask questions.

The bitesize talks will be live broadcasted on the EMA website and no registration is required.  

Clinical trial sponsors are encouraged to review the CTIS Sponsor Handbook and CTIS training materials prior to the bitesize talks, so that questions can focus on items not covered in the existing materials.

The calendar of events is below. The topics proposed are tentative and may be adjusted based on user needs.

Additional CTIS events will be added to the EMA events page throughout 2022. Interested parties can subscribe to the CTIS newsletter and the more regular CTIS newsflash by emailing to be informed of the latest updates.

Need more information ?

BeCRO will share events from our members on the condition that attendance is free of charge


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