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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
CDER Small Business and Industry Assistance 1.5 Hour Web Series: Statistical Considerations for Premarketing Risk Assessment
May 16, 2024

Activity Coordinators:
Forest Ford (,  Brenda Stodart (,  Matthew Palumbo (
Series Description

FDA's CDER Small Business and Industry Assistance (SBIA) educational webinars target the needs of health care professionals working in the pharmaceutical industry. Subject matter experts from the FDA explain trending drug development topics, (e.g. labeling, adverse events, quality) new guidance's 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. The SBIA goal is to provide drug labeling, quality, adverse event, promotion, and other regulatory learning opportunities to audiences.

Lecture Description
This presentation will describe important statistical considerations in the premarketing assessment of drug safety. The safety profile of a drug evolves over time through gained experience and increased exposure. The use of diligent planning for safety and rigorous assessment of maturing safety data optimizes the ability to characterize the safety profile of a drug.

This presentation will cover the importance of planning for the safety assessment of a drug. A focus will be on planning to assess key risks in confirmatory trials to improve the quality and reliability of the safety data collected for these risks. Such a task requires clear specification of the key risks, operational definitions of the risks and plans to ascertain them, and other trial design and conduct considerations to facilitate their assessment at trial completion.

This presentation will also cover statistical considerations in the analysis of safety data, primarily adverse event data. Analysis of adverse outcomes is not a simple calculation of crude proportions of the number of participants experiencing the event. Rather it requires careful consideration about the approach to analysis, including topics such as handling of treatment discontinuation, using data from multiple trials, defining summary measures of incidence, and choosing statistical methods to estimate the incidence and corresponding uncertainty.
  • FDA Guidance Benefit-Risk Assessment for New Drug and Biological Products (October 2023)
  • FDA Guidance Premarketing Risk Assessment (March 2005)
  • ICH Guidance E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions (March 1995)
  • ICH Guidance E9 Statistical Principles for Clinical Trials (September 1998)
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:
  • Identify how trial design can enhance the assessment of safety data
  • Cite the importance of tailoring the analysis of safety to align with trial design
  • Explain appropriate analysis approaches to assess causal relationships between drug and adverse outcomes
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
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.

Lecture 1 May 16, 2024
Time Topic Speaker
1:00 - 2:30 PM EDT Statistical Considerations for Premarketing Risk Assessment Gregory Levin, PhD
Matthew Soukup, PhD
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 1.5 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.50 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-24-013-L99-P for 1.50 contact hour(s).
FDA Center for Drug Evaluation and Research designates this activity for 1.50 contact hour(s).
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 ( 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 *CPE Monitor sets a strict 60-day limit on uploading credits.


  • Levin, Gregory, PhD, Associate Director for Statistical Science and Policy, FDA/CDER/OTS/OB - nothing to disclose
  • Soukup, Matthew, PhD, Deputy Division Director, FDA/CDER/OTS/OB/DB7 - nothing to disclose

Planning Committee
  • Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - nothing to disclose
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

CE Consultation and Accreditation Team
  • Henderson, Darlise, MBA, 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.