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!
FDA's Human Subject Protection (HSP)/Bioresearch Monitoring (BIMO) Initiative: A Progress Report on New Regulations, Guidances, and Partnerships
Upcoming Courses
In response to public concern, and federal inquiry, stemming from myriad current events involving the oversight of the products it regulates, the FDA has recently developed and issued new regulations, guidance, and procedures to support the agency’s mission to improve the conduct of clinical trials, assess the accuracy and reliability of clinical trial data, and secure the protection of human research participants involved in those trials. This web seminar will address some of the incidents that have led to these new developments, the federal agencies involved in overseeing the FDA, their findings, and how the FDA’s response to the recommendations will impact the conduct of clinical trials.
- Describe causal factors and their relationship to the current clinical research environment
- Examine key areas of concern from Congress, the Office of the Inspector General (OIG), and the General Accounting Office (GAO)
- Identify new regulations, guidances, procedures, coalitions, working groups, and pending and proposed legislation
- Clinical Quality Assurance Professionals
- Clinical Research Associates
- Project Managers
- Investigators
- Study Coordinators
- IRB Professionals
- Institutional Officials involved in oversight of clinical research
- GCP-Focused Regulatory Affairs Professionals
Elizabeth Ronk Nelson, MPH
Click here for complete trainer biographies
$595
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#: 0778-0000-12-074-L01-P. Released: 11/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
