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NEWS

Department of Regulatory and Quality Science and SC CTSI Organize Workshop for Asia-Pacific Countries under International Center for Excellence in Teaching Program

The specially scheduled regulatory science boot camp event was part of a multinational effort led by Asia-Pacific Economic Cooperation to harmonize regulations governing medical devices to expand trade among 21 Pacific rim countries. Regulators and scholars from several nations attended the boot camp during a four-day training event hosted by the USC School of Pharmacy.

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Regulatory Science Boot Camp Lecturers Discuss Processes and Requirements in Patient-Centered Drug Development

The patients who actually take medications and live with their conditions are uniquely qualified to contribute to the drug development process. An evolving body of research regulations and approaches seek to ensure that patients' perspectives are incorporated into studies in a meaningful manner.

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Pharmacovigilance and Safety Reporting are Topics at Recent Regulatory Science Boot Camp

Lecturers examined the FDA's regulatory requirements for the monitoring, detection, assessment, and safety reporting of adverse effects of drugs, devices, and other medical products.

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USC Researchers Prepare Human Trials of Potential Breakthrough Treatments for Devastating Genetic Skin Disorder

Two Department of Dermatology investigators have shown that a commonly-used antibiotic can trigger production of a collagen protein type necessary for normal skin.

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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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Guiding Role of Regulatory Science in Drug and Device Candidate Development Explored in Recent Regulatory Science Bootcamp

Lecturers at the latest meeting of the ongoing seminar series discussed the role of regulatory science in shaping development goals and clinical trials for medical device or drug candidates.

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Emerging Technologies and Treatments is Topic of Latest Regulatory Science Bootcamp

The seminar investigated the regulatory, scientific, and logistical considerations in clinical trials involving emerging technologies, cutting edge devices, immunotherapies, gene therapies, and stem cell therapies.

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Clinical Trials in Special Populations is Topic of Latest Regulatory Science Bootcamp

The seminar explored the unique regulatory, ethical and scientific concerns and safeguards required for research with newborns, geriatric, and institutionalized or vulnerable populations, and others.

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NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.