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:
Clinical Trials Information System (CTIS) sponsor end user training programme – April 2024
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.
Besides this information, we would like to make our followers aware of our Pharmacovigilance and Clinical Safety Services!
And in another short of terms, please notice that PVpharm is organizing a Training on several topics related to Pharmacovigilance and Clinical Safety in Madrid (also available online). Please see here:
**PVpharm is also organizing in-house training in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.**