Adverse Event Reporting Compliance:The Key to Safe Drug Development / Subject Safety 2014 is a webinar that covers topics such as:
- How to know what an Adverse Event is and when to report it or them
- The definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more
- Understanding laboratory AEs and the "Reference Range" concept
- Knowing the AE types and likelihood of finding "rare" events
- Reporting of Adverse Events - when and to whom and the use of AE Terminology systems
- Common Mistakes in AE / SAE Reporting
- How to record Adverse Events and assess causality - the algorithm
Adverse Event Reporting Compliance:The Key to Safe Drug Development / Subject Safety 2014 is intended for investigators and their staff with responsibilities in the regulatory / legal and ethical considerations from pharmaceutical product (Drug or device) research involving human subjects.
