Maxer attends the EMA webinars on CTIS

Maxer Consulting consultants attended the two SME and Academia Clinical Trials Information System (CTIS) training webinars, organized by EMA on February 22 and March 4.

The first session on February 22 focused on the new EMA platform’s purposes and the registration procedures. One of the characteristic features of CTIS is that it tha. This aspect was studied in depth during the presentations, just like managing the access profiles to the platform by the sponsors.

At the end of the presentations, the speakers’ panel answered the participants’ questions. EMA did not make public The number of participants.

On March 4, after the recapitulation of what emerged the previous day and the recall of EU Regulation 536/2014, the speakers illustrated:

  • the procedure for submitting and updating a Clinical Trial Application (CTA)
  • the methods of responding to the Request for Information
  • the application of Non-substantial modification.

Once again, the speakers’ panel answered the participants’ numerous questions and then gave way to the second part of the session, dedicated to the sponsor’s activities during the life cycle of the study. In particular, the presentations concerned:

  • the submission of notifications
  • the submission of results and layperson summaries
  • publication of the results contained in the CTIS.

The last part of the work focused on questions and answers, above all on submitting the results of clinical studies and their publication. Concerning the latter issues, many aspects are still to be defined. EMA is planning further training activities to complete the platform’s organizational and functional profile and better understand its impact on the sponsors’ organizations and their delegates in registering studies and publishing their results.