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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:

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.**