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RKSP will provide training, knowledge, and services to assure that investigators in our diverse and challenging Los Angeles environment can efficiently conduct translational research at the highest standards of ethics and quality and in full compliance of applicable laws, regulations, policies, and guidelines.
RKSP will provide IND/IDE and other regulatory guidance to CTSI investigators; create common regulatory processes among the CTSI academic partners to remove regulatory barriers; enhance and expand on the current regulatory training; implement a Continuous Quality Improvement Initiative in collaboration with the Center for Human Studies; and share and adopt best practices in regulatory knowledge and support through educational programs.
The Regulatory Knowledge and Support Program (RKSP) will play an important role in achieving the CTSI goals by providing investigators with regulatory support and education required for high quality clinical and translational research. Four main resources are integral parts of the RKSP and can be accessed for information, expertise, and sources to link CTSI investigators with specialized translational research:
Regulatory Science Graduate Program: a rapidly growing and internationally recognized program with offerings that span certificate to doctoral studies.
USC Stevens Institute for Innovation: outstanding expertise in product development and commercialization and partnered with the CTSI through the Center for Scientific Translation.
USC Department of Biomedical Engineering, Faculty of Medicine, and the Alfred Mann Institute: a track record of outstanding device development.
CTSI Center for Human Studies: integrated Quality Assurance – Safety Program on the Clinical Trials Unit.
Dr. Richmond is Professor of Pharmacy and the Director of the USC Regulatory Science Program. She has published more than 100 articles in basic and regulatory science, and is an invited speaker internationally on topics related to medical product development and commercialization. She has been a regulatory director of the Alfred Mann Institute, and has served as a consultant to medical device companies and to Industry Canada of the Canadian Government.
Dr. Kuo is the Manager of the Regulatory Consulting Center in the Regulatory Science Program at USC. He earlier managed regulatory affairs at the Alfred Mann Institute, with responsibility for IDE applications, submissions to the FDA, and regulatory compliance with the agency and IRBs. He is certified in U.S. regulatory affairs by the Regulatory Affairs Professional Society. He previously worked as a bioinformatics scientist, patent specialist, and certified patent agent. He received his Ph.D. in biomedical sciences and postdoctoral training at Stanford University.
