Benson Kuo - FDA Clinical Translational Research Rules and Regulations
C. Benson Kuo, PhD
Associate Director, International Center of Regulatory Science
Preclinical Translation and Regulatory Support, SC CTSI
University of Southern California
In this first session, Dr. C Benson Kuo, PhD introduces us to Regulatory Science, offers information about educational resources available at USC within the Regulatory Science Program, School of Pharmacy and helps us understand the knowledge and skills we need to master in order to identify:
1. How any particular research project fits within a planned clinical translational research process to address a clinical need for an identified populations.
2. How to find relevant laws and regulations governing clinical translational research on the Food and Drug Administration website.
3. How to recognize when an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) application is needed for human research involving investigational products.
1. Strengthening a workforce for innovative regulatory science in therapeutics development: Workshop summary (2012). The National Academies Press.
Available at: nap.edu/catalog.php?record_id=13283
2. Advancing regulatory science at FDA. A strategic plan. August 2011.
Available at: fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf
SC CTSI - Education and Career Development Seminar Series:
Facilitator: Cecilia M. Patino-Sutton, MD, PhD, Director of Education, SC CTSI ECDE, Department of Preventive Medicine
Media Technology: Gary San Angel, Distance Education Specialist, Department of Preventive Medicine