Renovating Good Clinical Practice (GCP): Risk-Based Quality Management and ICH E6(R3)

Session details:

ICH E6(R3) introduces innovative provisions designed to apply across various types and settings of clinical trials, ensuring continued relevance in the face of ongoing technological and methodological advancements. This guideline provides a new language to facilitate innovations in clinical trial design, technology, and operational approaches. It encourages a risk-based and proportionate approach to conducting clinical trials, promoting fit-for-purpose solutions. It fosters transparency through clinical trial registration and result reporting and offers additional guidance to enhance the informed consent process. In this session we will examine what this means in 2025 as companies continue to move to RBQM practices.