This event will be showing a ACRP Webinar Replay
Event Description:
This 60-minute webinar will help clinical research, regulatory affairs, and Good Clinical Practice quality professionals decode the complexities of the updated guidance. Leslie will break down the key shifts, themes, and differences between R2 and R3, provide real-world examples to simplify the changes, and introduce a framework to help identify gaps and prioritize the next steps for compliance. Attendees will be equipped to evaluate their organization’s alignment, identify priority actions for compliance, and start bridging the gaps.
Speaker:
Leslie Sam, BA, CSSBB, CQIA President
Learning Objectives:
- 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.