You are currently viewing Clinical Trials Information System (CTIS) training 2-5 May 2023

Clinical Trials Information System (CTIS) training 2-5 May 2023

  • Post published:April 27, 2023

José Alberto Ayala Ortiz will participate as a trainer in the next CTIS training organized by the EMA and the DIA. Please see the link below:

https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-sponsor-end-user-training-programme-may-2023

https://www.diaglobal.org/en/ema/course-listing/2023/02/ema-clinical-trials-information-system-sponsor-user-training-programme

EMA offers a virtual training programme, organised by DIA, to support sponsor user preparedness for the new Clinical Trials Information System and the new way of submitting a clinical trial application and managing the life cycle of a clinical trial in the European Union (EU) and European Economic Area (EEA).

A hands-on approach is taken to explaining and demonstrating the functionalities of the system, such as user management, how to submit an initial application as well as modifications, both substantial and non-substantial. Also, how to manage the life cycle of a Clinical Trial, how to apply Deferral rules and respond to a Request for Information (RFI) will be addressed.

**PVpharm is also organizing in-house training in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.**