Drug Safety and Adverse Events Reporting

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.

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

Prerequisites :

Offering code Offering title
CTDM.X411 Good Clinical Practices
CTDM.800 Medical / Clinical Terminology

Sections :

Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X409.(4) 6/1/2019 08:30 AM SANTA CLARA $580 Maria Filippou-Frye Enroll