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
The appropriate planning and conduct of integrated clinical trial safety analyses is critical to the success of drug marketing applications submitted to the FDA. As the safety analytics field is dynamic and evolving, continuous learning is required for the multiple disciplines (medical staff, statisticians, medical writers, etc.) that need to collaborate to create the necessary integrated tables, figures, and analyses.
This workshop will discuss how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. In addition, common mistakes seen in integrated analyses will be discussed to help avoid repeat errors.

References

• FINAL FDA Guidance: Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products https://www.fda.gov/regulatory-information/search-fda-guidance-documents/meta-analyses-randomized-controlled-clinical-trials-evaluate-safety-human-drugs-or-biological
• DRAFT FDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-pdufa-products

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:

• Explain when to contact the FDA for discussion around integrated safety analysis plans.
• Identify common mistakes in integrated safety analysis.
• State best practices for integrated safety analysis.

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.

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

• Ford, Forest, PharmD, R. Ph, CSO, FDA - nothing to disclose
• Lal, Renu, Pharm.D., Pharmacist, FDA - nothing to disclose
• Levin, Gregory, PhD, Associate Director for Statistical Science and Policy, FDA/CDER/OTS/OB - nothing to disclose
• Nilsson, Mary, MS, Executive Director-Statistics, Eli Lilly and Company - I have the following relationship(s): Eli Lilly and Company - Employee
• Pei, Yang Veronica, MD, MPH, MEd, FACEP, FDA/CDER/OND/ODES/BIRRS Associate Director of Biomedical Informatics, LCDR, U.S. Public Health Service - nothing to disclose
• Proestel, Scott, MD, Senior Medical Officer, CDER, Biomedical Informatics and Regulatory Review Science Team - nothing to disclose
• Soukup, Matthew, PhD, Deputy Division Director, FDA/CDER/OTS/OB/DB7 - nothing to disclose
• Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - 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