A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
Disqualification of Clinical Investigators: Proposed Rule and FDA Transparency Initiative
Upcoming Courses
After scrutiny from the Office of Inspector General and Congressional reports, the FDA has reexamined its procedures for disqualification of Clinical Investigators and dissemination of information surrounding its processes and determinations. As a result, the FDA has issued a proposed rule that would amend the federal regulations to expand the scope of disqualifications and make information on compliance and enforcement activities more accessible. This web seminar will review the recent changes, the reasons behind them, and what they mean for Clinical Investigators, sponsors, and IRBs.
- Discuss FDA considerations for initiation of disqualification proceedings
- Examine the FDA’s disqualification process (Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE), consent agreement, Notice of Opportunity for Hearing (NOOH), hearing, and final decision)
- Discuss recent disqualifications and the documented reasons for the administrative action
- Explore the FDA’s Transparency Initiative and its relation to Clinical Investigator disqualifications
- Evaluate the scope of the FDA’s proposed rule for disqualification of Clinical Investigators
- Professionals from Academia involved in the oversight, documentation, and conduct of clinical research
- IRB Members, IRB Professionals, and Institutional Officials involved in the oversight of clinical research
- Clinical Quality Assurance Auditors
- Clinical Quality and Compliance Professionals
- Clinical Research Associates
- Project Managers
- Regulatory Affairs Professionals
- Clinical Investigators
- Sponsor-Investigators
- Sponsor and CRO Representatives
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer biographies
$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-11-060-L01-P. Released: 9/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
