CDER Small Business and Industry Assistance 1-Hour Webinar Series: FDA Safety Report Type Flag Requirement for FAERS Submissions
February 19, 2021
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.
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.
- 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
- Solve FDA drug regulatory issues as they arise.
- Explain new FDA regulatory initiatives.
- Describe the benefits of the FDA Safety Report Type Flag in FAERS.
- Describe what factors should be considered for implementation.
This activity is intended for physicians, pharmacists, and nurses.
Lecture 1 February 19, 2021
|1:00 - 2:00 PM||FDA Safety Report Type Flag Requirement for FAERS Submissions||
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.
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.
- De, Suranjan, SUPERVISORY HEALTH SCIENCE, FDA nothing to disclose
- Rementelas, Nikolaos, IT Project Manager, Food and Drug Administration nothing to disclose
- 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 is complimentary, therefore refunds are not applicable.
- This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network.
- This system is provided for Government-authorized use only.
- Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties.
- Personal use of social media and networking sites on this system is limited as to not interfere with official work duties and is subject to monitoring.
- By using this system, you understand and consent to the following:
- The Government may monitor, record, and audit your system usage, including usage of personal devices and email systems for official duties or to conduct HHS business. Therefore, you have no reasonable expectation of privacy regarding any communication or data transiting or stored on this system. At any time, and for any lawful Government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this system.
- Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose.