How Due Diligence in Accurate Adverse Event Reporting is the Key to a clean FDA Audit (Clinical Training)
Venue: Online Event
|Event Date/Time: Aug 19, 2011||End Date/Time: Aug 19, 2011|
Areas Covered in the Seminar:
- The CFR definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse - Device Effects and many more.
- How to know what an Adverse Event is and when to report it or them.
- Knowing the AE types and likelihood of finding â€œrareâ€ events.
- Understanding laboratory AEs and the "Reference Range" concept.
- Common Mistakes in AE / SAE Reporting.
- Reporting of Adverse Events - when to use the AE Terminology systems.
- How to record Adverse Events and assess causality - the algorithm.