First study subject approvals package for phase I in healthy volunteers (SAD, MAD, FE)

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