DIA and FDA Advancing Regulatory Science Initiatives and Statistical Approaches for Building Evidence for the Approval of New Therapies

April 24: Short Courses* 
April 24-26: Forum

Highlights

• Two engaging Keynote Addresses from Janet Woodcock, MD, Director, CDER, FDA, and Kenneth I Kaitin, PhD, Professor of Medicine; Director, Tufts Center for the Study of Drug Development, Tufts University School of Medicine
• In-depth discussions on the two new FDA Guidances and the PDUFA VI reauthorization
• Summary of key forum take aways
• Two interactive half day Short Courses for even more knowledge-sharing
• Poster Presentations from researchers across the statistics field
• Luncheon Round Table Discussions on cutting-edge topics with key thought leaders
• Town Hall: An open discussion lead by an expert panel of leaders from industry and regulatory agencies
• Each session is co-chaired by an Industry/FDA team

DIA and FDA have focused this Forum on statistical thinking to inform policy, regulation, development, and review of medical products in the context of the current scientific and regulatory environments including pharmaceuticals, biologics and biosimilars, combination products and devices, and generics. Each session will be co-chaired by an FDA/Industry team working side-by-side with today’s experts to present a 360 degree perspective of statistical design, analysis, and methodological approaches to building evidence for pharmaceutical, biologic and biosimilar, combination product and device development, and approval.

This program is developed in collaboration with the Statistics Community.

Approved by the Regulatory Affairs Professionals Society for 12 RAC credits.