The ICH GCP R3 Roadmap: The Challenge of Vendor Management

ICH E6(R3) introduces a new mindset for oversight of service providers, emphasizing proportionate risk management and systems-based quality rather than procedural compliance. These changes profoundly affect how sponsors – but also CROs –  select, qualify, and monitor service providers for clinical trials. This presentation examines how the principles of E6(R3) challenge conventional vendor management by reinforcing ultimate sponsor accountability. It highlights practical strategies for translating these expectations into risk-based selection, qualification and oversight. The session offers a pragmatic framework for adapting vendor management practices to the evolving regulatory expectations defined in ICH E6(R3).