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

Regulatory Aspects of Clinical Trial Design Bootcamp Session 5: Case Studies and Future Trends (2018)

In this session, we will discuss trends in drug development in 2017 and look at case studies that reflect these trends.

Tagged: drug development, regulatory science, 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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