Beth Bieze, Katherine Mary Marangio, and Leslie Sam led an interactive Q&A session at the ACRP Annual Conference on April 27, 2025, where attendees had the opportunity to ask questions in an informal setting and benefit from knowledge-sharing with their peers.
This session continued the conversation from ACRP’s live webinar, Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3), which helped clinical research, regulatory affairs, and GCP quality professionals decode the complexities of the updated guidance.
The discussions explored when will the ICH E6(R3) guideline become effective, how long does the industry have to update their SOPs, will clinical researchers need to retake their GCP training, the omission of Annex 2, and much more.
Speakers:
Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Quality Management Director, ProTrials Research Inc.
Katherine Mary Marangio, Learning Program Consultant, Parexel Academy
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
Registration:
This conference replay is included in the ACRP 2025 Full Replay Package and the ACRP 2025 Regulatory & Compliance Track Replay Package. ACRP members may purchase the replay packages at reduced rates. ACRP Organization and Access Members have access to this replay in your My Learning dashboard.
If you attended ACRP 2025, this replay is also available in your My Learning dashboard, depending on your registration type.
Related Resources:
Watch the Webinar Replay Ahead of the Q&A Session (Free Without Contact Hours): Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3)
ACRP’s 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.
Approved for 1.0 ACRP Contact Hours | Expires May 23, 2028