ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop

The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop offers short courses, concurrent sessions, roundtables, poster sessions, and many opportunities to network.

The method of planning and organizing the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is unique from other conferences, as it has a more “grassroots” style. The workshop was originally a meeting for FDA statisticians that later expanded to include all statisticians interested in statistical practices for all areas regulated by the FDA. Although the workshop achieved attendance of more than 1,200 statisticians in 2021, it maintains the same grassroots approach for its planning. By bringing both FDA and industry speakers into each session, the highly valued original intent of the conference is maintained. The value is enhanced further when academic speakers can be engaged, as well as speakers from other regulatory agencies. The result is the most relevant conference for statistical practitioners in the biopharmaceutical arena.

Sessions featuring Laura Fernandes, COTA’s Senior Statistical Director in Medical:
Real-World Data in Regulatory Decision-Making
Sept. 22 at 2PM
Statistical Challenges in Conducting Single Arm Studies Utilizing Real-World Data for Oncological and Hematological Diseases
Sept. 22 at 2:50PM


Sep 20 - 22 2022


All Day


Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road, Rockville, MD 20852

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