An Overview of Pharmacovigilance in the Center for Drug Evaluation and Research (CDER)

Activity: FDA Drug Topics
kim swank, PharmD Faculty
pharmacist
FDA
 
Lesley Navin, RN, MSN Activity Coordinator
Consumer Safety Officer
FDA/CDER/DDI
 
Tue, 3/26 2019: 1:00 PM  - 2:00 PM 
Regularly Scheduled Series 
FDA 
Credits:
This webinar will give an overview of how the FDA conducts pharmacovigilance activities, detect safety signals, and communicates safety findings.

Objectives

Define pharmacovigilance|Describe the Division of Pharmacovigilance’s (DPV’s) key safety roles in FDA’s Center for Drug Evaluation and Research (CDER)|Explain components of postmarketing drug safety surveillance|Describe the role of MedWatch for reporting postmarketing safety information|Discuss how adverse event reports are collected and analyzed by FDA/CDER/DPV