A lot has happened this year! Get up to speed with this overview session designed to bring you the highlights and breaking news since last year's ACRP Conference. How are recent legal and regulatory changes fundamentally affecting research? What should research sites and institutions be ready for in the coming months and years? Get answers to these questions and more through this session's issue-spotting exploration and analysis of changes in laws, regulations, and standards promulgated by FDA, DHHS, the NIH, and ICH.