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“FDA Post-Marketing Drug Safety Surveillance”

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research presents as part of its webinar series…

“FDA Post-Marketing Drug Safety Surveillance”

This series of educational webinars is designed to aid Pharmacists, Nurses, Physicians, Physician Assistants, students, and other health care professionals in providing better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety. This webinar will provide an overview of pharmacovigilance, which is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems, and will describe FDA’s pharmacovigilance activities.

Learning Objectives:

  1. Define pharmacovigilance and adverse drug reactions
  2. Describe the Division of Pharmacovigilance (DPV)
  3. Identify the components of post-marketing drug safety surveillance
  4. Cite regulatory requirements and the role of MedWatch for reporting post-marketing safety information
  5. Summarize how adverse event reports are collected and analyzed by FDA/CDER/DPV

Presenter:

LT. Ofir Noah Nevo, PharmD, BCPP

There is no cost for this program.

Target audience: Physicians, Nurses, Pharmacists, Pharmacy Technicians, Physician Assistants

Continuing Education Credit:

  • Physicians: The Food and Drug Administration, Center for Drug Evaluation and Research is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Food and Drug Administration – Center for Drug Evaluation and Research designates this live activity for a maximum of 1 AMA PRA Category 1 Credit(s). Physicians and Physician Assistants should claim only the credit commensurate with the extent of their participation in the activity.
  • Pharmacy: The FDA-Center for Drug Evaluation and Research is accredited by the Accreditation Council for Pharmacy Education as a Provider of continuing pharmacy education. (ACPE Universal Activity No. 0601-0000-17-025-L04-P and ACPE Universal Activity No. 0601-0000-17-026-L04-T). This program meets the criteria for 1 contact hour(s) of pharmacy education and pharmacy technician education.
  • Nursing: FDA, Center for Drug Evaluation and Research is an approved provider of continuing nursing education by the Maryland Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. This 1 contact hour Education Activity is provided by FDA, Center for Drug Evaluation and Research. Each nurse should claim only the time that he/she actually spent in the educational activity.

Please visit www.fda.gov/DDIWebinars for future webinar dates and information.

Please direct your comments or questions via email to DDIWebinars@fda.hhs.gov