September 2, 2009
Drug Development and Regulatory Sciences Course
On Thursday, October 2, 2009, Ted Grasela, President and CEO of Cognigen Corporation, lectured on the topic: Model-Supported versus Model-Based Development - Implications for Leading and Governing R&D Programs during the American Course on Drug Development and Regulatory Sciences (ACDRS), which is presented by the University of California San Francisco School of Pharmacy. Session 1 of the ACDRS was held from Wednesday, September 30, to Friday, October 2, 2009, at the University of California, Washington Center, in Washington DC.
The ACDRS is a nonprofit educational course established in 2006 by the Department of Biopharmaceutical Sciences, School of Pharmacy, University of California, San Francisco (UCSF) and the Center for Drug Development Science (CDDS) at 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 program provides education and training in the field of medical product development at an advanced level. The ACDRS is targeted for the biopharmaceutical industry and its service industries, academic and government scientists and decision- and policy-makers who already have a good grounding in the basics and will benefit from a more in-depth, comprehensive and systematic immersion into modern medical product development, regulation and market introduction.
To be eligible for enrollment in the ACDRS, applicants must have a higher university degree, such as MD, PharmD, PhD, Master’s, or JD and a primary interest in medical product discovery, development, regulation or related activity. ACDRS is a postgraduate level education program, and is particularly aimed at professionals who are involved in the medical product development process and have at least one to two years of working experience.
The course is given in 6 sessions over 2 years:
Session 1 The Pharmaceutical Enterprise: Current and Future Perspectives
Session 2 Learning Trials: From Discovery to First in Humans
Session 3 Learning and Confirming Trials: Finding and Confirming the Right Dose
Session 4 Confirmatory Trials: Methodology and Biostatistics
Session 5 The Global Registration and Approval Process
Session 6 Integrated Product Development Strategy, Execution and Program Management