Designing Risk-Based QA Oversight for Clinical Trials Under ICH E6 (R3)

by | May 4, 2026 | Resources, Webinars

Designing Risk-Based QA Oversight for Clinical Trials Under ICH E6 (R3)

Watch this expert-led webinar from ADAMAS Consulting and Cyntegrity on how to design practical, risk-based QA oversight strategies that align with evolving ICH E6 (R3) expectations.

ICH E6 (R3) places greater emphasis on proportionate, risk-based approaches to clinical trial quality. For QA teams, this means moving beyond retrospective checks and building oversight models that use data, risk intelligence, and clear documentation to focus attention where it matters most.

In this on-demand session, Shehnaz Vakharia, Vice President, Asia Pacific at ADAMAS Consulting, and Dr. Artem Andrianov, Managing Director and Founder of Cyntegrity Germany GmbH, discuss how sponsors can strengthen QA oversight, use RBQM outputs more effectively, and support inspection-ready decision-making across the clinical trial lifecycle.

Key takeaways

  • Translate ICH E6 (R3) expectations into a practical QA oversight approach
  • Use trial data to generate risk intelligence and focus QA effort
  • Apply RBQM outputs to prioritize audits, oversight activities, and follow-up actions
  • Strengthen inspection readiness through clearer rationale, documentation, and decision-making
  • Move from retrospective QA checks to more continuous, insight-driven oversight

 

Speakers

Shehnaz Vakharia
Vice President, Asia Pacific
ADAMAS Consulting

Dr. Artem Andrianov
Managing Director, Founder
Cyntegrity Germany GmbH

Please submit form to access content.

Archives