The newly released ICH E6(R3) Good Clinical Practice (GCP) guidelines mark a transformative shift in clinical trial design, conduct, and oversight. This workshop will provide an in-depth analysis of these changes and their real-world applications, equipping clinical research professionals with the knowledge to implement them effectively.
The latest revisions emphasize modernized trial methodologies, enhanced technology adoption, greater flexibility in trial designs, and a stronger focus on patient-centric approaches. Through case studies and expert discussions, attendees will gain insights into how these changes impact regulatory compliance, trial efficiency, and data integrity.
Join us to explore how the latest GCP updates are shaping the future of clinical research and discover practical strategies for integrating these innovations into your trials.
Who Should Attend
This workshop is designed for:
Clinical research professionals, including CRAs, CRCs, and Clinical Project Managers
Sponsors, investigators, and regulatory professionals
Medical writers and data management specialists
Anyone involved in clinical trial design, monitoring, or compliance seeking to stay ahead of regulatory changes
Workshop Outline
This workshop covers the following topics:
Introduction to ICH E6(R3) and the evolution of GCP
Modernized Trial Design and Conduct
Enhanced Use of Technology
Improved Trial Design Flexibility
Patient-Centric Approach
Regulatory and Compliance Considerations
Learning Outcomes
Understand Key Updates in ICH E6(R3):
Gain a comprehensive understanding of the latest updates in ICH E6(R3) and how these changes impact clinical research operations and compliance.
Apply Modernized Trial Methodologies:
Learn how to integrate modernized trial methodologies to improve trial efficiency, ensure compliance, and streamline operational processes.
Leverage Technology for Data Integrity:
Understand the role of technology in enhancing data integrity and improving trial monitoring, ensuring high-quality, reliable results.
Implement Patient-Centric Strategies:
Explore patient-centric strategies designed to improve recruitment, retention, and engagement, ensuring a more successful clinical trial outcome.
Develop a Roadmap for Implementing GCP Guidelines:
Gain practical insights into how to implement the new GCP guidelines into day-to-day clinical trial operations, ensuring seamless adaptation and compliance.
All participants will receive a certificate of attendance upon completion of the workshop.
Recorded Webinar – Future-Proofing Clinical Trials: Essential GCP Updates You Need to Know