FDA’s Role in Postmarketing Drug Safety Surveillance
February 8, 2022 - December 31, 2024
This webinar provided an overview on how the FDA conducts postmarketing drug safety surveillance at the Center for Drug Evaluation and Research (CDER). We discussed how adverse event reports are collected, analyzed, and communicated to the public.
- World Health Organization. The Importance of Pharmacovigilance: Safety Monitoring of medicinal products. (2002). Available at: http://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf?ua=1. Accessed July 8, 2021.
- Strom BL, Kimmel SE, Hennessy S. Pharmacoepidemiology 5th edition (2012). Hoboken, NJ: Wiley-Blackwell.
- U.S. Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) Public Dashboard. Available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm.
- U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Available at: https://www.fda.gov/Safety/MedWatch/default.htm.
- U.S. Food and Drug Administration. MedWatch Consumer Voluntary Reporting (FORM FDA 3500B). Available at: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf.
- Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff. Available at: https://www.fda.gov/media/130216/download.
- Describe FDA’s drug safety surveillance system at the Center for Drug Evaluation and Research (CDER).
- Explain the MedWatch Program and how you can have an impact on signal detection.
- Discuss how adverse event reports are collected and analyzed.
- Demonstrate how safety findings are communicated to the public.
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH) Professionals, and physician assistants.
Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians, physician assistants, and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Faculty
- Kim, Tiffany, PharmD, safety evaluator, FDA - nothing to disclose
Planning Committee
- Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
- Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
- De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
- Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
- Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
- Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
CE Consultation and Accreditation Team
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
All relevant financial relationships have been mitigated.
Registration is complimentary; therefore refunds are not applicable.
Must attend 100% of the activity.
Initial Release Date
February 8, 2022
Expiration Date
December 31, 2024