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    EU Clinical Trials Information System training programmes

    22.01.2021
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    The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application.

    One change is the introduction of the EU Clinical Trials Information System (CTIS), through which all communication related to a clinical trial application and assessment will take place. The Clinical Trials Regulation, Regulation (EU) No 536/2014, will become applicable as CTIS goes live, which is anticipated in December 2021.

    The European Medicines Agency has developed different training programmes to future CTIS users. The State Agency of Medicines is suggesting the companies involved in the conduct of clinical trials to participate in the trainings.

    1. For Micro, Small to Medium Enterprises (SMEs) and academia EMA is organising a two part webinar. On 22/02/2021 CTIS access management, user management and different roles in CTIS will be presented. On 4/03/2021 CTIS functionalities will be focused on - how to submit and manage a clinical trial application. The webinar will include presentations by speakers from EMA system experts and presenters from SME and academic institutions, demonstration of the system and opportunities for questions and answers.

    Steps to take:

    • Complete the expression of interest questions: EUSurvey - Survey (europa.eu) by 29/01/2021.
    • A separate email from EMA will be sent including a link to register for the training. Registrations will close on 7/02/2021. You will need to register for both dates individually

         

     2. Webinars for industry and Contract Research Organisations

    a) Introduction of Organisations Management Service (OMS) and Referentials Management Service (RMS) activities, on 03/02/2021 and 04/02/2021. The credentials to join the meetings will be sent on a request trials@ravimiamet.ee

    b) CTIS Sponsor Master Trainers’ Programme for commercial sponsors from the Pharmaceutical Industry and Contract Research Organisations. The programme will start in Q2. For any questions related to the CTIS Sponsor Master Trainers Programme, please contact emaevents@diaglobal.org

     

    In case of CTIS related questions please contact: trials@ravimiamet.ee