The Association of Clinical Research Professionals

Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3)

Are you ready to crack the code on ICH E6(R3) and confidently navigate the transition from ICH E6(R2)? This 60-minute webinar helps clinical research, regulatory affairs, and GCP quality professionals decode the complexities of the updated guidance.

Leslie Sam breaks down the key shifts, themes, and differences between R2 and R3, provides real-world examples to simplify the changes, and introduces a framework to help identify gaps and prioritize the next steps for compliance. At the webinar’s conclusion, attendees will be equipped to evaluate their organization’s alignment, identify priority actions for compliance, and start bridging the gaps.

Whether your focus is clinical operations, quality assurance, or regulatory affairs, this interactive webinar will give you the confidence and tools you need to take action—cracking the code and preparing for ICH E6(R3) with clarity, confidence, and compliance.

Upon completion of this continuing education program, participants should be able to:

  • Identify the key similarities and differences between ICH E6(R2) and ICH E6(R3) at a thematic level.
  • Decode how ICH E6(R3)’s high-level themes apply to clinical research practices and organizational processes.
  • Apply a practical framework to evaluate compliance and prioritize actions for bridging procedural and process gaps.

Speaker:

  • Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC

Approved for 1.0 ACRP Contact Hours | Expires February 13, 2028