This session will provide a high-level overview of the emerging regulatory environment governing clinical research. There are many trends to keep track of as actions by the current administration in the White House affect available funding, workforce readiness, and research priorities in governmental, academic, industry, and private practice settings.
Further, recent and forthcoming updates to various U.S. Food and Drug Administration guidance, International Council for Harmonization guidelines, and ethical, safety, and efficacy concerns in the design and conduct of drug and device clinical trials will make this a valuable session for all stakeholders across the entire clinical research enterprise.
CEU: 1.00 ACRP
Speaker:
David Vulcano, LCSW, MBA, CIP, RAC, FACRP, Vice President, Clinical Research Compliance & Integrity, HCA Healthcare