Sponsor or Organizer: Global Compliance Panel

Description: Overview: This presentation will focus on the major regulatory issues that concerns diagnostic and pharmaceutical partners during co-development of a targeted therapeutic and companion diagnostic.

Areas Covered in the Session: Current trends in personalized medicine Coordination of clinical trials during co-development FDA draft guidance on CDx CDx/IVD regulatory framework and anticipated changes in EU Proposed interactions with the regulatory agencies Regulatory review process Case studies Who Will Benefit: Regulatory Affairs Business Development Top Management Research and Development Preclinical and Clinical Development

Dates: Wednesday, June 20, 2012

Location: Online Training, Delaware, United States