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Educational Sessions

FDA Drug Safety Updates: Year in Review

Tuesday, December 10, 2024

2:00 PM – 3:00 PM

Location: MCCNO, Room 280, Level 2

CE Credits: 1.00 contact hours

Activity #: 0204-0000-24-296-L05-P
Activity #: 0204-0000-24-296-L05-T
Activity Type: Knowledge-based
Target Audience: Pharmacist, Pharmacy Technician

Learning Objectives:

Describe the process of pharmacovigilance at the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER).
List three important safety updates that FDA issued over the previous year and the evaluation process and evidence leading to these changes.
Explain how to submit a spontaneous adverse event report to FDA and important elements that should be included to constitute a high-quality submission.

Program Chair(s)

Jennifer G. Naples, PharmD, BCGP, BCPS (she/her/hers)

Safety Evaluator, Division of Pharmacovigilance
U.S. Food and Drug Administration

Moderator(s)

Jennifer G. Naples, PharmD, BCGP, BCPS (she/her/hers)

Safety Evaluator, Division of Pharmacovigilance
U.S. Food and Drug Administration

Faculty Member(s)

Scott Janiczak, PharmD, MPH, BCPS

Safety Evaluator
U.S. Food & Drug Administration
Jennifer G. Naples, PharmD, BCGP, BCPS (she/her/hers)

Safety Evaluator, Division of Pharmacovigilance
U.S. Food and Drug Administration