This web seminar provides newcomers a thorough introduction of FDA regulations in the field of medical device safety. The course includes a comprehensive review of the requirements, current compliance approaches for professionals in the research and post-marketing areas, and opportunities to discuss the challenges facing those reporting and managing Adverse Events in the medical device industry.
- Describe current considerations in reporting Adverse Events in clinical trials: Terminology, consent, device-related versus procedural complication, and follow-up
- Differentiate between terminology related to Adverse Events and devices
- Define the objectives of documenting Adverse Events in both investigational and marketed devices
- Describe the reporting requirements for investigational and marketed devices
- Summarize the considerations required for Adverse Event reporting with combination products and in-vitro diagnostics
- Discuss the IRB’s role in Adverse Event reporting
- Clinical Trial Personnel (Monitors, Managers, Research Coordinators, Support Staff) responsible for: 1) Collecting, reviewing, and reporting Adverse Events occurring in clinical trials of new and marketed products; and 2) Ensuring Adverse Event reporting compliance at the investigator site
- Quality Personnel involved in the investigation of Adverse Event reports
- Regulatory Affairs Personnel responsible for submitting safety reports to the FDA and other health authorities
- Medical Affairs Personnel responsible for safety-related decisions regarding product labeling, regulatory interactions, or customer communication
Douglas Albrecht, B.S.N..C.C.R.A.
Click here for complete trainer biographies
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#: 0778-0000-13-003-L01-P. Released: 1/13.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.