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Course

Drug Safety and Adverse Events Reporting | CTDM.X409


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.

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Prerequisite(s):

Sections Open for Enrollment:

Open Sections and Schedule
Start / End Date Units Cost Instructor
12-04-2021 to 12-11-2021 1.5 $550

Narinder Singh

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Schedule

Date: Start Time: End Time: Meeting Type: Location:
Sat, 12-04-2021 8:30 a.m. 5:00 p.m. Classroom SANTA CLARA
Sat, 12-11-2021 8:30 a.m. 5:00 p.m. Classroom SANTA CLARA