Regulatory Science Series

This Career Development Seminar Series dedicated to Regulatory Science (6 two-hour sessions) brings together experts across USC that integrate key regulatory science knowledge and skills for conducting clinical translational research with the goal of accelerating health related discovery to the public.

Although we all have heard about regulatory science, many of us still are not aware of what it really is or why it is so closely aligned with successful clinical translational research. During these six sessions the USC experts intend to discuss important components of this science that FDA defines as “the science that develops new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA regulated products”.

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.

Resources:

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

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