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ABOUT THIS WEBINAR

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 webinar 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 you avoid making the same mistakes.

INTENDED AUDIENCE

• Pharmaceutical regulatory scientists, clinical reviewers, medical professionals, data scientists, statisticians, statistical programmers, medical writers working on integrated clinical trial safety analyses for new drug marketing applications.
• We will not be discussing trial data for generic drug applications.

TOPICS COVERED

• Importance of early planning
• Types of issues to discuss at FDA Type C meeting for integrated safety
• How to create integrated analysis sets for safety assessment
• Appropriate analytical and statistical methods when combining clinical trial data from multiple studies

LEARNING OBJECTIVES

• Understanding when to contact the FDA for discussion around integrated safety analysis plans.
• Understanding common mistakes in integrated safety analysis.
• Using best practices for integrated safety analysis.

FDA SPEAKERS | PANELISTS

Scott Proestel, M.D.
Senior Medical Officer
Division of Biomedical Informatics, Research, and Biomarker Development (DBIRBD)
Office of Drug Evaluation Science (ODES)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)

Veronica Pei, M.D., MPH, MEd
Associate Director for Biomedical Informatics
DBIRBD | ODES | OND | CDER

Mary Nilsson
Executive Director-Statistics
Safety Analytics Working Group (FDA|PHUSE)
Eli Lilly

Gregory Levin, Ph.D.
Associate Director for Statistical Science and Policy
Office of Biostatistics (OB)
Office of Translational Sciences (OTS) | CDER

Matthew Soukup, Ph.D.
Deputy Director, Division of Biometrics VII
OB | OTS | CDER

FDA RESOURCES

• FINAL FDA Guidance: Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products
• DRAFT FDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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