Investigator Initiated (Sponsored) Trials – ISSs is a webinar that covers topics such as:
- Who is the Investigator?
- Who is the Sponsor?
- FDA and European nomenclature and regulations
- Who is the Applicant and how do you submit?
- Directive 2001/20/EC
- 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?
Investigator Initiated (Sponsored) Trials – ISSs brings together:
- 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
- Legal Affairs
