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!
Placebo Trials for Medical Devices: FDA’s Steps to Ensure Reliability of Medical Devices
Upcoming Courses
As of 2014, device companies must consider the placebo effect in clinical trials and how placebo controls will affect their regulatory approval pathway. Randomized, placebo controlled trials are not new to those in the pharmaceutical industry, but they have not traditionally been the norm for device trials. Approval in the EU does not assure approval in the U.S. Will Congress be asked “to ensure that all devices provided to patients be safe and effective” rather than “reasonably” safe and effective? What are the ethical considerations? How will this issue affect conducting medical device clinical trials in the U.S. and abroad? Sponsors should be prepared to discuss and defend their position on the necessity of a placebo controlled trial. This web seminar will provide strategies for adapting to this changing regulatory landscape. The course instructor, a former FDA insider, will share case studies to help sponsors and investigators better prepare for unanticipated FDA questions.
- Determine if and when it may be necessary for placebo trials
- Interpret FDA’s current thinking on clinical trials to ensure reliability of medical devices
- Optimize time with the FDA to facilitate and capture what sponsors need to fulfill regulatory requirements
- Consider the ethical ramifications on placebo controlled studies
- Regulatory Affairs Professionals
- Sponsors
- Clinical Research Professionals
- Clinical Research Associates
- Investigators and Site Staff
- IRB Professionals
- Project Managers
- Auditors
Jerri Barden Perkins, M.D.
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 1.5 hours (0.15 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#: 0778-0000-15-021-L01-P. Released: 2/15.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
