Workshops are NOT included with Full Conference registration and require a separate fee.
Since ICH E6(R3) was finalized, the industry has recognized that implementation goes beyond updating SOPs. It requires new ways of working, proportionate risk-based approaches, and a culture that prioritizes quality and critical thinking. This interactive workshop builds on the momentum of ACRP’s “Crack the Code” webinar, diving into the realities of R3 implementation.
Through the “Top 10 Lessons,” we’ll examine challenges and successes—embedding Quality by Design in protocol development and site operations, overseeing service providers, making data governance actionable, and defining what qualifies as an “important” protocol deviation.
Lessons will be brought to life with concise teaching segments, case studies, and interactive activities. Participants will practice applying these lessons to realistic scenarios, discuss solutions with peers, and leave with practical tools that support judgment and decision-making in their own studies.
At the core of the workshop is change management, engaging stakeholders, equipping teams with the right tools, and empowering people to embrace new ways of working.
By the end of this workshop, attendees will be able to:
Describe the 10 most common lessons emerging from R3 implementation
Recognize where organizations over-engineer or under-apply R3 principles
Apply R3 expectations to:
Protocol design
Oversight and roles
Data governance
Deviations and inspection readiness
Identify one concrete action to improve implementation in their organization
CEUs: 5.50 ACRP
Trainer:
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates
Related Resources: