How Due Diligence in Accurate Adverse Event Reporting is the Key to a clean FDA Audit (Clinical Training)

Venue: Online Event

Location: Online Event,Palo Alto, California, United States

Event Date/Time: Aug 19, 2011 End Date/Time: Aug 19, 2011
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Description

This webinar will show how you can determine the relationship between the study drug and an AE by accurate observation & using good medical judgment.

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 “rare” 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.

Venue

Online Event
2600 E. Bayshore Road
California
United States
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