This course provides newcomers a detailed and 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.
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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.