Biostatistics and FDA Regulation: The Convergence of Science and Law
Tuesday, May 20, 2014, 8:00am – 5:00pm
Wasserstein Hall, Milstein West AB, Harvard Law School, 1585 Massachusetts Ave.
Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center.
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 to 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 give 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. The full conference agenda is available on the website.
Registration is required in order to attend this event. Please register here.
Registration fees (Note: “Member” and “Non-Member” Rates refer to membership in FDLI.)
$495 Member
$595 Non-Member
$350 Government Member
$420 Government Non-Member
$195 Academic Member
$299 Academic Non-Member
$195 Student Member
$195 Student Non-Member
A limited number of current Harvard affiliates may register for free. For details, please contact the Petrie-Flom Center at petrie-flom@law.harvard.edu or 617-496-4662. All other students must pay the academic/student member rate of $195.
