Discover how the new ICH GCP E6(R3) guidelines are transforming clinical trials with a focus on patient-centricity, digital innovation, and risk-based quality management. Join this webinar to explore key changes and their impact on sponsors, CROs, investigators, and ethics committees.
The new ICH GCP E6(R3) guidance, effective July 2025, signals a significant shift towards more flexible, patient-centered and digitally supported clinical trials. With only 11 streamlined principles, E6(R3) emphasizes proportional risk management, robust data governance and clearer stakeholder responsibilities — all while prioritizing patient safety and data integrity.
But who does this impact? In short, everyone. Sponsors must now implement risk-based quality systems and maintain oversight even when outsourcing. CROs and service providers face increased expectations for innovation and compliance. Investigators and trial sites must demonstrate realistic recruitment capabilities and manage data with precision and accuracy. Furthermore, ethics committees are tasked with reviewing digital consent and recruitment materials, and patients are at the center of trial design, engagement and retention.
The featured speaker in this webinar will highlight the key elements of the new guidelines and explore their real-world implications for clinical research stakeholders.
Register for this webinar to learn how ICH GCP E6(R3) is reshaping global clinical trial standards and expectations.
Attendees will learn about:
クレア・リッチズ
Citeline Clinical Solutions担当バイスプレジデント
クレアは最近Citelineに加わったばかりですが、製薬業界で25年以上にわたる臨床研究および商業戦略の豊富で優れた経歴を持っています。彼女のキャリアは、プロジェクトマネジメントからクライアント対応、事業部長、大手CROでの治療領域リーダーまで、幅広い臨床分野に及びます。
直近ではSyneos Healthにて、欧州の主要製薬企業との関係を担当するSVP（グローバルクライアントソリューションリーダー）として活躍。現在はNorstellaの商業リーダーシップチーム、ソリューションコンサルティング、Citelineの営業、臨床製品戦略など、Citelineの主要部門と密接に連携しています。
Pierre Mermet-Bouvier, PhD
Senior Manager, eClinical Strategy & Delivery, ICON plc
Pierre Mermet-Bouvier, is currently Senior Manager, eClinical Strategy & Delivery, at ICON plc. He held senior positions in global pharmaceutical & CRO companies for 30 years, in Clinical Operations, Project Management Office, Regulatory Affairs & Long-Range Planning. He has a long history of Regulatory Intelligence & information sharing.