CFR Sec. 312.3 Definitions and interpretations (FDA)
Who has the intellectual property rights?
Who holds the IND?
Who has liability for drug adverse events?
Who has publication rights?
Who provides drug supplies?
Who provides financial support?
What are the regulatory reporting requirements?
Who write the informed consent?
Who provides the study information on Clinicaltrials.gov (US) or European Clinical Trials Database (EudraCT Version 8.0, operational since 10 March 2011?
Who should Attend
Pharmaceutical medical support personnel who work in clinical research or medical affairs who may initiate or oversee IISs by their company
Pharmaceutical Medical Directors in Clinical Research and Medical Affairs
Investigators at study sites interested in conducting ISSs
CRAs, CDAs, MSLs, Managers, etc
Farm bureaus and members
Coordinators at study sites who must manage the process
