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Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences. Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval. Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point up the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA. This one-day symposium will provide attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and will also address closely related issues residing at the intersection of statistical analysis and life sciences litigation.
A Symposium Presented by DIA, FDLI and Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
Who Should Attend
- Regulatory attorneys
- Law students
- Government attorneys
- Industry members who use clinical trials
At the conclusion of this meeting, participants should be able to:
- Describe the increasing importance of biostatistics in food and drug law context
- Explain basic biostatistical principles and related disputes in legal settings
- Identify statistics issues in FDA regulation
- Discuss emerging issues such as precision medicine, next-generation statistical analysis and comparative effectiveness measures