FDA/DIA Statistics Forum 2013

7th Annual DIA/FDA Statistics Forum
Tutorials: April 28, 2013
Statistics Forum: April 29-May 1, 2013

Learn about and discuss the current and emerging statistical methodologies and quantitative approaches in the development and regulatory review of medical products.

Now in its seventh year, this unique workshop continues the dialogue on issues including FDA guidance development and regulatory science initiatives including PDUFA V initiatives. The dialogue will focus on statistical opportunities and challenges associated with data standards and innovative approaches to the design, monitoring, analysis and reporting of clinical trials and assessments of safety and effectiveness in the pre- and post-market settings.

The Forum offers in-depth discussions on key topics relevant to the evaluation of therapeutic products and includes input from key thought leaders from regulatory agencies, industry, and academia.

Further communication from DIA will be sent later this year or early next year when the program for 2013 is complete. Please also monitor the DIA website for Continuing Education information.

This program will be developed by FDA and the DIA Statistics Special Interest Area Community (SIAC).

Co-sponsored by FDA