Purchase the recording of a web seminar you have attended in the past and SAVE 50%! Contact Barnett Customer Service for details: +1 781.972.5400 or toll-free in the U.S. at 800.856.2556.
Web Seminar Archives provided through Barnett’s Learning Management System (Single User access) or by electronic file transfer (Site License).
Site license archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.
Bulk Archive access is available via Barnett’s Training Subscription. Click here to learn more.
Archive: Final AE Regulatory Guidance
Course Description
This web seminar presents content and impact discussion of the FDA and Office of Human Research Protections (OHRP) Adverse Event reporting guidance documents. The guidance documents address issues of Adverse Event information exchange between stakeholders and propose solutions to the issues of the quality of information being sent to the IRBs. The guidance impacts the activities of the research site, IRB, and sponsor/CRO’s role in compiling and/or communicating Adverse Event information during a research study, changing the industry’s current practices.
Video Preview
Learning Objectives
- Appreciate the changing regulatory climate and the impact on safety reporting in clinical trials
- Explain the global response and recommendations for more meaningful safety reporting between stakeholders
- Describe the FDA’s response: January 2009 Final Guidance
- Describe the OHRP’s response: January 2007 Final Guidance
- Recognize implications for current practices
- Examine case scenarios
Who Should Attend
- Sites: Principal Investigators, Clinical Research Coordinators, Managers
- Sponsors: Clinical Research Associates, Sponsor Clinical Operations, Safety Information Specialists, Regulatory Professionals
Instructor
The course will be led by one of the following instructors:
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer biographies
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.