Investigator Initiated (Sponsored) Trials â€“ ISSs (Clinical Compliance)
Venue: Online Event
|Event Date/Time: Sep 13, 2012||End Date/Time: Sep 13, 2012|
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.
The goal of this training is to help the clinical research professionals avoid liability, identify opportunities for improving the processes for conducting ISSs and to describe ways companies and study sites can best interact.
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.