Pharmacovigilance and Safety Reporting Boot Camp Session 2: Regulatory Requirements (2018)

In this series, we will discuss pharmacovigilance and safety reporting in clinical trials. Case studies are presented throughout the series.

Tagged: device development, drug development, regulatory science, clinical trials

Pharmacovigilance and Safety Reporting Boot Camp Session 6: Safety Reporting in Industry-Sponsored Trials and Case Studies - Part 2 (2018)

In this series, we will discuss pharmacovigilance and safety reporting in clinical trials. Case studies are presented throughout the series.

Tagged: device development, regulatory science, clinical trials

Regulatory Aspects of Clinical Trial Design Bootcamp Session 4: Unique Designs for Medical Device Trials (2018)

In this session, we will discuss how medical device trials are conducted in Europe and the United States and how these trials differ from pharmacological trials.

Tagged: device development, regulatory science, research ethics, clinical trials

Regulatory Science Series

Six lecturers provide in-depth reviews of the federal FDA and other regulations and guidelines that govern all aspects of clinical and translational research on new drugs and biomedical devices.

Tagged: device development, drug development, regulatory science, research ethics, responsible conduct of research

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