Conducting clinical trials on a global scale presents unique challenges, including navigating dynamic regulatory requirements and diverse landscapes. This session will examine The U.S. Food and Drug Administration's  21 CFR Part 11 from the Code of Federal Regulations and its European Union counterpart, EudraLex Annex 11, to uncover the foundational requirements for utilizing electronic records and electronic signatures in clinical trials conducted within these regions.

CEU: 1.00 ACRP

Speaker:

• Sara Saunders, MHA, CCRP, Sr. Manager, Regulatory Affairs, Florence 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.