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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
FDA Drug Topics: Electronic Submission of Safety Reports – Ready for Primetime?
April 30, 2024
Zoom

Activity Coordinators:
Thanh Nguyen-Chu (Thanh.Nguyen-Chu@fda.hhs.gov),  Kara Burke (Kara.Burke@fda.hhs.gov),  Kimberly De Fronzo (Kimberly.Defronzo@fda.hhs.gov)
Series Description

FDA's Division of Drug Information in the Center for Drug Evaluation and Research (CDER) sponsors a series of educational webinars targeting the needs of health care professionals and students. The webinars cover a broad range of FDA drug regulation and medication safety topics. These focused webinars support FDA's mission of promoting and protecting public health through interaction and education to strengthen current and future partnerships and relationships with clinicians and researchers.

Lecture Description
This session will review updates to requirements for submitting safety reports for investigational new drug (IND) applications, IND-exempt BA/BE studies, and approved drug and therapeutic biologic products (excluding vaccine) using the ICH E2B(R3) format; implementation status and progress; testing updates; and submitter preparedness and readiness.
References
  • 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
  • FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (Aug 2022) - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-regional-implementation-guide-e2br3-electronic-transmission-individual-case-safety-reports-drug
  • FDA E2B(R3) Core and Regional Data Elements and Business Rules v1.5 (Oct 2023) - https://www.fda.gov/media/157982/download
  • FDA E2B(R3) Forward Compatible Rules (Apr 2022) - https://www.fda.gov/media/157993/download
  • FDA ICSR XML Instances (Sep 2023) - https://www.fda.gov/media/157983/download
  • Electronic Submission of IND Safety Reports Technical Conformance Guide (Apr 2022) - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-ind-safety-reports-technical-conformance-guide
Series Objectives
  • Explain how to utilize FDA's Drug Information, medication safety resources, and regulatory guidances to improve delivery of patient care and optimize outcomes.
  • Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.
Learning Objectives After completion of this activity, the participant will be able to:
  • Recognize that FDA will require reporting of IND and postmarket safety reports to be submitted in the ICH E2B(R3) format to FAERS via the Electronic Submission Gateway or the Safety Reporting Portal.
  • Identify the updated requirements since the last publication that are key for postmarket, IND, and IND-exempt BA/BE safety reporting.
  • Describe the implementation status and progress of premarket and postmarket safety reports in E2B (R3) format.
  • Explain how to prepare for the electronic exchange of safety reports.
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.
Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.
Agenda

Lecture 1 April 30, 2024
Time Topic Speaker
1:00 - 2:00 PM EDT Electronic Submission of Safety Reports – Ready for Primetime? Suranjan De, MS
Jung Lee, MPH, R. Ph
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 JA0002895-0000-24-002-L99-P, and ACPE Universal Activity Number JA0002895-0000-24-002-L99-T for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
AAPA
This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. PAs should only claim credit commensurate with the extent of their participation.
CPH
Up to 1.00 CPH Recertification Credits may be earned at this event.
Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor. If you do not see your credit reflected on CPE Monitor* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov. *CPE Monitor sets a strict 60-day limit on uploading credits.

Disclosure

Faculty
  • De, Suranjan, MS, SUPERVISORY HEALTH SCIENCE, FDA - nothing to disclose
  • Lee, Jung, MPH, R. Ph, Pharmacist, Food and Drug Administration - 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
  • Littlefield, Jr, Kenneth P., Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.