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Quality by Design Toolkit
This toolkit offers an overview of Quality by Design’s objectives, workflow, advisory board, and consultation services, supporting SC CTSI researchers in enhancing the quality and efficiency of their studies and ultimately increasing study success rates.
View this serviceRegulatory Science Symposium: "Ensuring Clinical Trial Compliance" Session 1 - Welcome
Dr. Eunjoo Pacifici, Chair of the Department of Regulatory and Quality Sciences, welcomes attendees to the symposium.
regulatory & quality sciences, study & site management, research & study conductRegulatory Science Symposium: Emerging Technologies/Treatments Session 1 - Regulatory Considerations (2017)
In this series, we will discuss regulatory considerations for conducting clinical trials in the era of emerging technologies and treatments.
regulatory & quality sciences, study & site management, research & study conductRegulatory Science Symposium: Emerging Technologies/Treatments Session 5 - Immunotherapy Trials (2017)
In this series, we will discuss regulatory considerations for conducting clinical trials in the era of emerging technologies and treatments.
regulatory & quality sciences, study & site management, research & study conduct
Legal Aspects of Clinical Trials Discussed at Recent Regulatory Science Boot Camp/Symposium
Principal investigators and regulatory professionals must stay up-to-date with numerous legal requirements and strategies pertaining to clinical studies. These include U.S. Food and Drug Administration (FDA) forms, contracts with sponsors, liabilities, indemnifications, special use protocols, and inventions to protect. And then there are international laws.
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Undergraduates Take Career Strides in SC CTSI's Regulatory Knowledge and Support Core—and Beyond
Research by undergraduate students has led to presentation opportunities and new career paths.
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SC CTSI Symposium Illuminates Complex World of Regulatory Science for Clinical Researchers
A day-long boot camp helps investigators understand the key steps and issues – as well as the potential benefits – in the fast-changing regulatory environment of clinical trial start-ups.
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SC CTSI Co-Director Urges Young Women To Study STEM Subjects
Michele Kipke, PhD, SC CTSI co-director, speaks at "Women in STEM: Designing, Discovering and Delivering Change.
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