On December 26, 2007, the Department of Veterans Affairs (VA) issued a directive that requires the use of Cooperative Research and Development Agreements (CRADAs) under 15 U.S.C. § 3710a for industry-sponsored studies performed at VA medical centers.  As of March 26, 2008, new clinical trial agreements will no longer be accepted.  BE PREPARED BY ATTENDING “Using VA CRADAs – A Conference for Industry Sponsors.” 

Each year, VA medical centers participate in thousands of industry-sponsored studies. If your responsibilities include negotiating clinical trial agreements, CRADAs or other forms of agreements for studies conducted at medical centers, you should attend this meeting. 

The primary conference speakers will be key VA personnel from VA’s Office of Research and Development (ORD), Technology Transfer Program (TTP) and the Office of General Counsel (OGC). Meet the VA officials directly responsible for VA technology transfer and CRADAs; learn about VA models, policies and procedures; and get answers to your questions. 

Opening remarks will be presented by: VA Undersecretary for Health Michael J. Kussman, M.D.; VA General Counsel Paul J. Hutter; and Ann Koch, Head, Clinical Master Agreements Group, Novartis Pharmaceuticals Corporation.

WHO SHOULD ATTEND?

Attending this conference is important for personnel of pharmaceutical and device manufacturers as well as individuals from clinical research organizations (CROs) that engage with Department of Veterans Affairs medical centers and investigators to perform research, particularly clinical studies. 

WHAT WILL YOU LEARN?

Attendees will gain a comprehensive understanding of CRADAs and how to negotiate them with VA.  Learn how the many advantages of using CRADAs and working with the VA-affiliated nonprofit research and education corporations to make research collaborations with VA easy.  Content will include an overview of the CRADA statute and details of VA’s model CRADAs, policies and procedures as well as “master” CRADAs that allow industry sponsors to negotiate one CRADA for use at all VA sites and for multiple studies.

WHO WILL CONDUCT THE TRAINING?

The conference speakers will be key VA personnel from VA’s Office of Research and Development, staff of the VA Technology Transfer Program and attorneys from the Office of General Counsel.