Live CE Webinar sponsored by the Division of Drug Information - Drug Information Update

FDA Drug Topics: An update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard 

Will be held on:

 October 9, 2018

Time:  1:00 pm to 2:00 pm (EDT)

To register for the online meeting, please visit:https://collaboration.fda.gov/ddi100918/event/registration.html 

 

After registering, you will receive a calendar invitation with details on how to join the online meeting.

Activity Outline 

Description: This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, other health care professionals, and students, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety. 

This webinar will provide an updated overview of the changes in the FAERS Public Dashboard, a highly interactive web-based tool that allows for the querying of FAERS data in a user-friendly fashion. These changes include displaying report counts by quarter and month, search by reactions and data export. The intention of this tool is to expand access to the FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, health care providers and consumers. FDA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public.

Series Objectives:

• Explain how to utilize FDA’s drug information, medication safety resources, and regulatory guidance, to improve delivery of patient care and optimize outcomes.
• Describe and inform health care providers of recent labeling changes which would impact prescribing and medication management to optimize patient care.

References:

1. FDA Adverse Event Reporting System (FAERS) Public Dashboard at: 
   https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm.
2. Questions and Answers on FDA's Adverse Event Reporting System (FAERS) at: 
   https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm2007060.htm. 

Learning Objectives: After completion of this activity, the participant will be able to: 

1. Describe the FAERS public database and summarize the recent updates.
2. Demonstrate how to use the FAERS public dashboard to view information on adverse event reporting metrics.
3. Illustrate use of FAERS public dashboard to view adverse event information on a specific product.

Target Audience: This activity is intended for physicians, physician assistants, nurses, pharmacists, pharmacy technicians, other health care professionals, and students.

Schedule:1:00 pm - 2:00 pm – FDA Drug Topics: An update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard, presented by Suranjan De, Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA.

Continuing Education Accreditation:

In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 1.00 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.

CMEFDA 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.
CPEThis knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-18-027-L04-P, and ACPE Universal Activity Number JA0002895-0000-18-027-L04-T for 1.00 contact hour(s).
CNEFDA Center for Drug Evaluation and Research designates this activity for 1 contact hour.
Requirements for receiving CE Credit:
Physicians, physician assistants, nurses, pharmacists, pharmacy technicians, 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). Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Pharmacy participants: Pharmacists and pharmacy technicians will need their NABP e-profile ID number as well as their DOB in MMDD format in order to claim CE credit.

Important Note regarding completion of evaluations and receiving creditAttendees have 14 days from the last day of the activity to log in, attest to your attendance, and complete the required evaluation survey, to claim credit. Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 10 weeks after the activity to obtain their CE credit.

Disclosure:
Faculty:

• De, Suranjan, SUPERVISORY HEALTH SCIENCE, FDA - nothing to disclose

Planning Committee:

• Burke, Kara, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
• DeFronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
• Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose
• Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
• Weinstein, Edward, M.D., Ph.D., Medical Officer, CDER/FDA - My spouse received salary from EndoCentre of Baltimore for a role as employee.

CE Consultation and Accreditation Team:

• Lisa Thompson, MSHA, MBA, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
• Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose
• Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose

Registration Fees and Refunds: Registration is complimentary therefore refunds are not applicable.
Please direct your comments or questions via email to DDIWebinars@fda.hhs.gov.
To learn more about future dates and registration, please visit: www.fda.gov/DDIWebinars.