Even after multiple ICH E6(R3) presentations, many research organizations still struggle with implementation. How should SOPs change? What happens when institutional policies conflict with R3 principles? How should sites revise deviation, oversight, documentation, and training procedures?

In this interactive office-hours session, attendees will bring real implementation questions, SOP excerpts, and operational challenges for discussion with experienced quality and regulatory experts. Rather than another lecture on the guideline itself, the focus will be on practical application, peer discussion, and actionable next steps.

Participants will leave with:

1. Strategies for updating SOPs and work instructions
2. Approaches for working within AMC and institutional governance structures
3. Examples of R3-aligned quality language
4. Practical solutions to common implementation barriers
5. Greater confidence preparing their organization for the transition to E6(R3)