July 23, 2010

ACDRS Course on New Drug Development

Enrollment is now open for the American Course on Drug Development and Regulatory Sciences (ACDRS) that starts October 25-27, 2010, in San Francisco.

The ACDRS is a postgraduate level education program designed for professionals who are involved in the medical product development process and have at least 1 to 2 years of working experience. Participants in ACDRS receive a rigorous, in-depth, comprehensive, and systematic immersion into modern medical product development, regulation, and market introduction. Last year, FDA sent 20 students to the course to join with about 45 students from industry and academia.

The ACDRS was established in 2006 as a nonprofit educational course by the Department of Biopharmaceutical Sciences, School of Pharmacy, University of California, San Francisco (UCSF) and the Center for Drug Development Science (CDDS), UCSF, working with the FDA, professional societies, a network of universities, biopharmaceutical companies, and the European Course in Pharmaceutical Medicine (ECPM), University of Basel, Switzerland. The ACDRS has more than 120 faculty members: about 50% are from regulated industry; 30% are from regulatory agencies; and 20% are from academia.

The six sessions listed below will be held at Mission Bay Conference Center at UCSF, San Francisco, CA. For details of each session, see the brochure for the previous course. To register, visit the ACDRS website.
1. October 25-27, 2010: The Pharmaceutical Enterprise: Current and Future Perspectives
2. February 28-March 3, 2011: Learning Trials: From Discovery to First in Humans
3. June 13-16, 2011: Learning and Confirming Trials: Finding and Confirming the Right Dose
4. October 17-20, 2011: Confirmatory Trials: Methodology and Biostatistics
5. February 27-March 1, 2012: The Global Registration and Approval Process
6. June 11-14, 2012: Integrated Product Development Strategy, Execution and Program Management