Towards Global Harmonization and Regulatory Convergence
The APEC-USC Center for Training Excellence
USC is one of only two US universities established by the Asia-Pacific Economic Cooperation and its Life Sciences Innovation Forum and Regulatory Harmonization Steering Committee as a Center of Training Excellence. The APEC-USC Center of Excellence (CoE) is part of the priority work area focused on medical devices. It signifies our excellence in teaching about harmonized regulations and standards in the medical product sector. Harmonization is an important goal with the potential to shorten paths to market, reduce industry and regulator workloads, and lower costs for drugs and devices.
Each year, APEC-USC CoE holds a multiday course that attracts regulators internationally, who is joined by students and local industry representatives. At the course trainees receive deep and current information on all aspects of regulatory management to improve patient access to new and important medical technologies. USC is model participant towards global regulatory convergence.
Forging Connections
Summer Visiting Scholars Program – Summerfest
DK KIM International Center for Regulatory Sciences (ICRS) takes seriously its goal support for visiting scholars and students who wish to expand their regulatory experience and knowledge. Every year, its popular Summerfest program brings to USC more than 50 students from academic partners around the world including universities in South Korea, China, India, Brazil and Taiwan. Participants learn about regulatory science, ethics and global health issues. They engage in presentations and cultural activities designed to break down borders and expose them to new career paths. To view photos from past Summerfests, click here.
For more information on Summerfest, email Benson Kuo at chiaoyuk@usc.edu
Regulatory Science Symposia
The DK KIM International Center for Regulatory Sciences (ICRS) in conjunction with the Southern California Clinical and Translational Science Institute hosts symposia on regulatory topics in clinical and translational science. Symposia are designed to educate students and professionals at various stages of career pathways on clinical research-related topics and developments in the regulatory environment. These symposia, presented by experts from academia, government, and industry, provide practical approaches that help enhance regulatory knowledge and ensure quality in clinical trials. This popular series, now in its fourth year, has been attended by research professionals and students from academia and industry training for careers in drug development and clinical research. Past topics include special populations, emerging technologies, regulatory aspects of clinical trial design, genomics including pharmacogenomics, big data and monitoring and auditing. To access recordings of past symposia.
Clinical Trial Quality Training Modules
The DK KIM International Center for Regulatory Sciences (ICRS) in conjunction with the Southern California Clinical and Translational Science Institute has developed open-access, self-study modules that train academic researchers in essential concepts and practical approaches in regulatory quality management for clinical research. These high-quality modules employ a multifaceted approach including educational videos, case studies, interactive quizzes, and core regulatory document templates such as standard operating procedures and review checklists. These modules are designed to educate learners with fundamental and practical knowledge of clinical research auditing, monitoring, and FDA site visit readiness, with an emphasis on investigator-initiated trials.
EMPACT: Empowering Purposeful Advancement of Careers and Training in the Research Workforce
The DK KIM International Center for Regulatory Sciences (ICRS) in conjunction with the Southern California Clinical and Translational Science Institute and the Georgia Clinical and Translational Science Alliance (Georgia CTSA)are collaborating on an exciting new educational venture geared toward clinical research professionals at every stage of their professional development. The idea for the Empowering Purposeful Advancement of Careers and Training in the Research Workforce (EMPACT) program was born out of a need for education and support for the entire clinical and translational research workforce, beyond formally trained faculty, trainees and fellows.
EMPACT courses and programs have been created and vetted by experts in cross-disciplinary fields such as instructional design, technology, workforce development, regulatory science, clinical and translational science, and operations. A Course Catalog with free course and program offerings aimed at clinical research professionals and principal investigators is available. Participants earn a certificate or badge with contact hours (continuing education – CE) from an accredited provider upon completion of a course or a program (series of courses). Contact hours can be used to meet requirements for CRP certification renewal. Click here to get started.