Investigator Initiated (Sponsored) Trials – ISSs

Why Should You Attend:

The legal and regulatory hurdles are a major pitfall for ISSs. Recent legislation and newly revised guidance documents for the pharmaceutical industry are being introduced regularly in light of the latest anti-kickback statutes. Pharmaceutical companies must carefully navigate the guidelines to ensure a successful outcome in these investigator-initiated studies without violating regulations.

This session is designed for clinical research professionals either at a pharmaceutical company or at a study site who are considering conducting ISSs and would like more information on the process to be able to abide by international regulations as well as understanding the process of how a company and sponsor collaborate.

 Areas Covered in the Seminar:

• Who is the Sponsor?
• Who is the Investigator?
• Who is the Applicant and how do you submit?
• FDA and European nomenclature and regulations.
  • CFR Sec. 312.3 Definitions and interpretations (FDA).
  • Directive 2001/20/EC.
• Who holds the IND?
• Who has the intellectual property rights?
• Who has publication rights?
• Who has liability for drug adverse events?
• Who provides financial support?
• Who provides drug supplies?
• Who write the informed consent?
• What are the regulatory reporting requirements?
• Who provides the study information on Clinicaltrials.gov (US) or European Clinical Trials Database (EudraCT Version 8.0, operational since 10 March 2011?