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!
Managing Risk Assessment and Signaling in the Pre-Marketing Setting
Upcoming Courses
Signaling and risk assessment/minimization is now required during all stages of drug development. Although the mechanisms for signaling and risk evaluation are best applied to marketed products, the FDA, European Medicines Agency (EMA), and other health agencies still expect companies and sponsors to do risk assessment/minimization and signaling during the pre-marketing clinical trial stage of a drug’s lifespan. In this web seminar, we will review the requirements and methodology for signaling and risk assessment/minimization in the clinical trial setting, allowing learners to set up mechanisms to handle these tasks and requirements either in-house or via third parties.
- Describe what pre-marketing risk assessment/minimization and signaling is
- Describe what is required and “nice to have” for risk handling and signaling
- Critically review Learners’ companies’ current risk and signaling procedures and determine whether additional procedures and processes are needed
- Structure a risk and signaling system
- Medical Personnel performing clinical trials
- Regulatory Personnel
- Compliance and Quality Assurance Personnel
- Drug Safety Operations Personnel
Barton Cobert, M.D., F.A.C.P., F.A.C.G.
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#: 0778-0000-14-075-L01-P. Released: 10/14.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
