FDA/DIA Statistics Forum 2014

Now in its eighth year, the DIA/FDA Statistic Forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs and biologics. This unique workshop continues the dialogue on issues including FDA guidance development and regulatory science initiatives.

You will have the opportunity to 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.

WHAT YOU WILL LEARN:

Key topics relevant to the evaluation of therapeutic products

Input from key thought leaders from regulatory agencies, industry, and academia

Regulatory and statistical solutions associated with innovative approaches to the design and analysis of clinical trials data

Examine your role in these changes and improvements to help develop appropriate, scientific/regulatory consensus.

A call for posters will open in December.

This program will be developed by FDA and the DIA Statistics Community.

Co-sponsored by FDA