SCORE Meeting Covers How to Handle FDA Inspections of Clinical Studies

This month’s SCORE meeting featured speakers who covered various aspects FDA clinical trial inspections, describing personal experiences and offering advice on how to prepare.  

New Requirements for Clinical Trials: What You Need to Know

New expanded legal policies from the U.S. Department of Health and Human Services and National Institutes of Health regarding registering and reporting results of clinical trials as well as funding and training will apply to many clinical trials that were not previously under any formal obligations. This article outlines what you need to know and a town hall meeting will be held October 27 to clarify details of the policies and answer any questions. 

CTSI Now Offers Advanced Certificate in Regulatory Science

The CTSI, in partnership with the Department of Public Health Sciences, is rolling out a new advanced certificate in regulatory science for graduate students, postdocs, and researchers from a broad range of fields. The program is just one of several efforts by the CTSI to advance regulatory science and promote student and trainee interest in learning how new drugs and devices are developed and ultimately reviewed by the Food and Drug Administration (FDA).

Meet the winner of the 3rd Annual “America’s Got Regulatory Science Talent” competition

Angela Ryck is the winner of the University of Rochester’s 3rd Annual America’s Got Regulatory Science Talent Student Competition Winner. She spoke with CTSI Stories about her project.