This meeting will give stakeholders an opportunity to influence the advancement of regulatory guidance by the US Food and Drug Administration (FDA) and other regulatory agencies expected circa 2011. This effort is currently in progress with PhRMA, the Extended PhRMA Imaging Group, CORAR, MICAA and many other stakeholders who are shaping best practices for standardizing medical imaging in clinical trials, including academia, professional imaging societies, non-profit consortia, governmental agencies, and regulatory authorities.