Adverse Events for Medical Devices May 2010

Course Description

This course provides newcomers a detailed and through 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 reserach and post-marketing areas, and opportunities to discuss the challenges facing thse reporting and managing adverse events in the medical device industry. 



Learning Objectives

  • 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 markete devices
  • Summarize the considerations required for Adverse Event reporting combination products and in-vitro diagnostics
  • Discuss the IRB's role in Adverse Event reporting

Who Should Attend

  • Clinical Trial Personnel (Monitors, Managers, Research Coordinators, Support Staff) responsible for: 1) collecting, reviewinf, and reporting adverse events occuring 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 FDA and other health authorities
  • Medical Afairs Personnel responsible for safety-releated decisions regarding product labeling, regulatory interactions, or customer communication


Douglas Albrecht, B.S.N..C.C.R.A.

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Course Length Time

2 hours; 1:00 - 3:00 p.m. Eastern

Course Dates 

May 4, 2010

Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471