Legend: Palais des congrès de Montréal = CC, Le Westin Montréal = W, Intercontinental Montréal = I
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
Activity Details
|
|
Tweet | ||
| 53 * | Sun, 8/4/2013, 4:00 PM - 5:50 PM | CC-511c | |
| Regulatory Considerations on Design and Analysis of Observational Studies — Invited Papers | |||
| Biopharmaceutical Section , Biometrics Section , Section on Statistics in Epidemiology , Scientific and Public Affairs Advisory Committee | |||
| Organizer(s): Lilly Yue, U.S. FDA | |||
| Chair(s): Donald B. Rubin, Harvard University | |||
| 4:05 PM | FDA/CBER Biologic Product Evaluation Using Observational Studies — Yun Lu, Food and Drug Administration | ||
| 4:20 PM | Safety Assessment with Observational Studies: Experiences at FDA/CDER — Mark Steven Levenson, Food and Drug Administration | ||
| 4:35 PM | Challenges and Opportunities with Observational Studies: A CDRH's Perspective — Lilly Yue, U.S. FDA | ||
| 4:50 PM | Discussant: Gregory Campbell, Food and Drug Administration | ||
| 5:05 PM | Discussant: Ralph Horwitz, GlaxoSmithKline & Yale University | ||
| 5:20 PM | Discussant: Allen Heller, Bayer HealthCare Pharmaceuticals | ||
| 5:35 PM | Discussant: Estelle Russek-Cohen, U.S. FDA | ||
2013 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.
The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Copyright © American Statistical Association.