Back by popular demand, this timely topic returns with fresh, interactive workshop scenarios, updated examples, and a deeper look at what organizations are learning as the International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice becomes a part of day-to-day clinical trial conduct.

Designed for newcomers and returnees alike, this year’s program expands the discussion with additional focus on how emerging lessons are shaping how teams are moving beyond early E6(R3) implementation in terms of applying risk-proportionate approaches, translating Quality by Design into trial execution, defining and demonstrating oversight, strengthening data governance, evaluating protocol deviations, and making tough but defensible decisions about what matters most.

Attendees will exchange perspectives across sponsors, contract research organizations, service providers, and investigator sites, and leave with practical tools, frameworks, and concrete actions they can put to use when they return to their organizations.

CEUs: 5.5 ACRP

Trainer:

• Leslie Sam, CQIA, SSBB, President, Leslie Sam and Associates, LLC