AEMPS approval to conduct the 3 phase I studies in healthy volunteers SAD MAD and FEThis package will include a final version of study protocol as approved by regulatory agencyiesethics committees a study registration number in EudraCT European Union Drug Regulating Authorities Clinical Trials Database and copies of opinions andor authorization from Institutional Data Protection Officer and National Data Protection Authority as appropriate
Handbook summarizing the operating rules of the project management office PMO
Availability of the project website online with external contribution of EDSA and national DS associations
Availability of a project logo and a professional corporate identity which will appear on all documents publications and ICOD presentations Flyers will be produced to be hand out at events at which the ICOD project will participate Youtube channel with videos conveyed on social networking sites for young people
Searching for OpenAIRE data...