Beyond Compliance: Embedding RBQM into the Clinical DNA—Lessons from the Roche CoE

About this session

While ICH E6(R3) provides the regulatory framework for modernised clinical trials, the real challenge lies in operationalising RBQM across a global portfolio. At Roche, this transition wasn't just a process update—it was a cultural transformation. This session pulls back the curtain on the Roche RBQM Centre of Excellence (CoE), sharing the successes, the "potholes", and the tangible lessons learned while embedding risk-based thinking from protocol concept through Quality-by-Design (QbD) to final reporting.

Speaker

• MW

  Madeleine Whitehead

  Process Excellence Leader, Product Development Quality Solutions · Roche Products Ltd.

  Speaker