Overview:
The final version of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 (R3) Guideline has been released. This key guideline sets international standards for clinical trial design, conduct and documentation to protect participants and ensure reliable data. This webinar addresses the practical implications of ICH GCP E6(R3) for sponsors, investigators and service providers, and explains how stakeholders can prepare for adoption and implementation.
The updated ICH E6 guidelines introduce major changes in both structure and content, creating significant challenges for all stakeholders who must adapt across multiple disciplines to achieve compliance. As the guideline advances to adoption and implementation, stakeholders need to thoroughly compare R2 and R3, update procedures and modify systems as necessary. ICON leverages its experience to navigate complex regulatory updates and help stakeholders adapt to ongoing compliance needs.
The release of ICH E6 (R3) signifies a critical milestone in the continuous improvement of international clinical research regulations. Emerging from over two decades of global collaborative efforts, these revised guidelines reflect both advancements in technology and evolving expectations around ethical research practices. The revision process involved extensive consultation among regulators, industry professionals, patient advocacy groups and other experts, ensuring that the new version is grounded in current scientific understanding and best practices.
One of the most notable features of ICH E6 (R3) is its emphasis on a risk-based approach to quality management throughout a clinical trial’s lifecycle. By promoting proactive identification and mitigation of risks, the guideline seeks to enhance participant safety and safeguard the integrity of clinical data. Additionally, there is expanded guidance on the use of emerging digital technologies, such as electronic health records and decentralised trial models, which are increasingly integral to modern research operations.
For sponsors, investigators, contract research organisations (CROs) and other stakeholders, the transition from R2 to R3 involves a comprehensive review of existing policies, training materials and systems. Stakeholders must allocate significant resources to identifying gaps between previous and current requirements, revising internal protocols and delivering comprehensive staff training to ensure ongoing compliance. The increased complexity of operational processes means organisations will need strategic planning and cross-functional collaboration to implement the new standards effectively.
In summary, the ICH E6 (R3) Guideline represents a significant evolution in global clinical trial governance. Its successful adoption demands proactive adaptation by the research community. Attendees will leave with practical steps to plan, prioritize and execute implementation activities across functions.
Register for this webinar to learn practical steps for implementing ICH GCP E6(R3) across global clinical trials.
Attendees will gain insight into:
- The background and purpose of the ICH GCP E6(R3) updates
- The structural and content-based changes, including the top five most impacted areas
- Risk impact assessment based on ICON’s comprehensive analysis of the guidelines
- The implementation of best practices and examples of ICON’s change management strategy in
action to help sponsors prepare for compliance
Target audience(s):
- Clinical Operations, Clinical Trial Managers and Coordinators
- Clinical Research Associates (CRAs)
- Project/Study Management, including Study Start-Up
- Regulatory Affairs professionals
- Quality Assurance personnel
- Therapeutic Heads, Medical Affairs
- Medical Writers, Protocol Developers and Study Designers
- Clinical Trial System Owners and Developers
Speakers:
Jo Hulbert
Jo Hulbert has over 28 years of experience in product development, clinical trials, pharmacovigilance and quality assurance. She specialises in clinical trials and regulatory affairs, providing strategic consultancy across pharmaceuticals, biologicals, medical devices and advanced therapies. She holds an MBA and is a Change Management Practitioner.
Jo Sprague
Jo Sprague brings over 26 years of experience in the clinical research industry, spanning both CRO and pharmaceutical environments. Her career has been primarily focused on regulatory affairs, where she has developed expertise across global regulatory landscapes. Jo has a broad clinical research perspective, her experience including roles in CRA, project management, pharmacovigilance and data management, where she contributed to studies across all phases of development.