www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
CDER Small Business and Industry Assistance 1-Hour Webinar Series: FDA Safety Report Type Flag Requirement for FAERS Submissions
February 19, 2021
Webcast
Activity Coordinators:
Lisa Misevicz (lisa.misevicz@fda.hhs.gov)
 
Series Description

FDA's CDER Small Business and Industry Assistance (SBIA) sponsors a series of educational webinars targeting the needs of health care professionals working in the pharmaceutical industry. Subject matter experts from the FDA explain trending drug development topics, new guidances or regulations, and/or FDA regulatory processes. These webinars support FDA's mission of promoting and protecting public health by bridging knowledge gaps about emerging regulatory issues or areas with frequently asked questions.


Lecture Description
FDA will introduce the FAERS FDA Safety Report Type Flag and communicate how to prepare for this new requirement. Topics will include the FDA Safety Report Type Flag, benefits associated with the requirement, and implementation considerations.
References
  • FDA Webpage: FDA Adverse Event Reporting System (FAERS) Electronic Submissions https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions
  • Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments https://www.fda.gov/media/132096/download
Series Objectives
  • Solve FDA drug regulatory issues as they arise.
  • Explain new FDA regulatory initiatives.
Learning Objectives After completion of this activity, the participant will be able to:
  • Describe the benefits of the FDA Safety Report Type Flag in FAERS.
  • Describe what factors should be considered for implementation.
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Agenda

Lecture 1 February 19, 2021
Time Topic Speaker
1:00 - 2:00 PM FDA Safety Report Type Flag Requirement for FAERS Submissions Suranjan De
Nikolaos Rementelas
Continuing Education Accreditation
Jointly Accredited Provider
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.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-21-025-L03-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, 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.

Important Note regarding completion of evaluations and receiving credit
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 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.
Disclosure

Faculty
  • De, Suranjan, SUPERVISORY HEALTH SCIENCE, FDA nothing to disclose
  • Rementelas, Nikolaos, IT Project Manager, Food and Drug Administration nothing to disclose

Planning Committee
  • Kleppinger, Cynthia, MD, Medical Officer, FDA nothing to disclose
  • Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/DDI nothing to disclose
  • Stodart, Brenda, PharmD, BCGP, RAC-US, Program Director, FDA nothing to disclose

CE Consultation and Accreditation Team
  • Catherine Harrison, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
ACCME Joint Accreditation
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