Adverse Event and Safety Reporting- Science, Assessment and Regulation 

Participants will:

 1.  Define the types of Adverse Events 2. Identify what makes an adverse event serious 3. Identify what makes an adverse event unexpected 4. Define and Discuss criteria for an unanticipated problem 5. Define protocol deviations and violations 6. Identify and discuss how to report the different types of adverse events 7. Identify the FDA regulations that relate to safety reporting