This session will provide a high-level overview of the emerging regulatory environment governing clinical research. With a new administration in the White House and recent and forthcoming updates to various U.S. Food and Drug Administration guidances, International Council for Harmonization guidelines, and more targeting ethical, safety, and efficacy concerns in the design and conduct of drug and device clinical trials, this is a session providing value for stakeholders across the entire clinical research enterprise.

CEU: 1.00 ACRP

Speaker:

• David Vulcano, LCSW, MBA, CIP, RAC, VP Clinical Research Compliance & Integrity, HCA Healthcare

Related Resource:

The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.