Home

Workshop
Objectives


Agenda

Sponsors

Presentations

Contact Us

Two Topic Imaging Workshop:
 Day One - Standards for Imaging Endpoints in Clinical Trials
Day Two - Manufacturing of Positron Emission Tomography (PET) Radiopharmaceutical Products

April 13-14, 2010
Natcher Conference Center
NIH Campus, Bethesda, Maryland

Thank you for your interest in the Two Topic Imaging Workshop which was held on April 13-14, 2010.

Presentations from the workshop are available.

The goal of this two-day scientific workshop is to generate discussion and establish consensus on issues associated with the use of imaging for assessing endpoints in clinical trials. 

The 2007 Prescription Drug User Fee Act (PDUFA) IV called for the development of a guidance document to address Imaging Standards for Use as an End Point in Clinical Trials. The United States Food and Drug Administration (FDA) is holding a discussion with stakeholders in the imaging community on key standardization and optimization issues and practices in clinical trials and drug development. 

The workshop is co-sponsored by the FDA, SNM and the Radiological Society of North America (RSNA) with key input from the National Cancer Institute's (NCI) Cancer Imaging Program (CIP). Biosketches for the Speakers, Moderators and Panelists are available. Contacts for the members of the press are listed in the April 1, 2010 press release.