Regulators, the public, and the medical community are scrutinizing the safety profiles of pharmaceuticals more closely than ever. Thus acquiring, verifying and reporting quality safety data are crucial to obtaining and maintaining product approval. This course introduces fundamental concepts essential to drug safety and adverse event reporting and how to apply them to situations encountered during clinical trials and post-marketing reporting. You'll learn why safety reporting is crucial; the definitions of an adverse event and the key reporting issues of seriousness, expectedness, and relationship to the study drug. The course includes a brief overview of reporting requirements in the U.S. and abroad and the documents associated with these reports. The content is appropriate for CRAs, CRCs, drug safety associates, and regulatory affairs personnel.

Learning Outcomes

At the conclusion of the course, you should be able to

• Describe fundamental concepts essential to drug safety and adverse events reporting
• Assess adverse events for causation, expectedness and seriousness
• Identify reporting requirements related to Study Drugs
• Apply drug safety concepts to clinical situations

Topics Include

• Background of Drug Safety in US
• Drug safety during pre-clinical and clinical trials
• Post-marketing drug safety surveillance
• Reporting issues related to drug safety

Skills Needed

• To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.

Notes

Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.