Value to Patients: Benefits, Risks, and Costs
The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop was originally a meeting for U.S. Food and Drug Administration (FDA) statisticians that later expanded to include all statisticians interested in statistical practices for all areas regulated by the FDA.
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 and speakers from other regulatory agencies are included. The result is the most relevant conference for statistical practitioners in the biopharmaceutical arena.
A successful workshop relies heavily on careful planning by hard-working volunteers. The selected Steering Committee members participate in biweekly meetings, starting with the kick-off at the current year workshop (in September) and continuing through February of the following year with teleconferences.
Several subcommittees support the two co-chairs, and the steering committee members review session proposals.
Selection of steering committee members is based on a series of factors, including balance between affiliations (FDA and industry), balance of experience levels in similar volunteer and organizational work, broad representation across companies (for industry representatives), a variety of interest areas and technical expertise, strong commitment, and active participation.
All are welcome to submit a session proposal and attend the organizing meeting held each year in late January or early February. A steering committee facilitates the organizing meeting by categorizing session proposals into statistical topics. This steering committee may preselect a few highly valued session topics for the workshop program and remove session proposals not meeting the submission criteria. The majority of the program is then the result of selection by those attending the organizing meeting and of the highest quality.