The ICH GCP E6 (R3) guideline represents a transformative global shift in Good Clinical Practice (GCP), aligning with the evolving expectations of regulatory agencies such as the FDA, EMA, and PMDA. With a strong emphasis on risk-based quality management (RBQM), data integrity, and technology-driven oversight, this update challenges sponsors, CROs, and sites to redefine their approach to compliance, quality, and clinical trial execution in an increasingly digital-first environment.
In this insight-driven webinar, our industry experts will demystify the key changes introduced in GCP E6 (R3) and examine how regulatory authorities worldwide are adapting to digital transformation in clinical trial oversight.
Attendees will gain global perspectives and actionable strategies on:
- Key updates in GCP E6 (R3) and their implications for sponsors, CROs, and sites
- The evolving role of risk-based quality management (RBQM) in clinical trial execution and regulatory expectations
- Harnessing AI, automation, and digital tools to optimize compliance, oversight and operational efficiency
- Best practices for ensuring data integrity and risk-based monitoring in a globally regulated digital environment
- Strategic steps to implement digital-first quality management approaches that comply with international regulatory requirements
