Networking Regulatory & Compliance track
ICH (E6)R3: Real-World Questions & Answers
Sun, Apr 27, 2025 · 9:15 AM CDT Hyatt Regency New Orleans
About this session
Are the ICH E6(R3) guideline changes keeping you up at night? If there are burning questions and specific scenarios you need answered—or you want to hear how your industry colleagues will handle the transition from E6(R2) to E6(R3) this 60-minute live discussion is for you!
Leslie Sam and Beth Bieze will lead this interactive Q&A session where you'll have the opportunity to ask questions in an informal setting and benefit from knowledge-sharing with your ACRP peers. There will not be a prepared lecture and presentation slides, so please come with questions!
This session will continue the conversation from ACRP's live webinar, Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3). The webinar content was designed to help clinical research, regulatory affairs, and GCP quality professionals decode the complexities of the updated guidance.
Some of the questions posed by the webinar attendees which may be addressed at ACRP 2025 include:
- When will the ICH E6(R3) guideline become effective?
- How long does the industry have to update their SOPs to include E6(R3) principles and guideline updates?
- Will clinical research professionals need to retake their GCP training?
- Is there a reason why Annex 2 was not included in the ICH E6 R3 before it was adopted?
- Does ICH E6(R3) allow the flexibility of an advanced practitioner to be the Principal Investigator?
- When will the ACRP Certification exams change to include ICH E6(R3) instead of E6(R2)?
CEU: 1.00 ACRP
Speakers
-
Clinical Quality Management Director · ProTrials Research Inc.
Speaker
