Webinar: ICH E6(R3) Essentials: A Draft Guidance Overview
Tuesday, February 6, 2024 | 1:30pm – 3:00pm EST
Recent changes to the international guideline for good clinical practice ICH E6 are extensive, significant, and scheduled to take effect in less than a year. ICH E6(R3), as currently published, is a completely revised guideline with no reference to the previous version, E6(R2). Karen Harvey, Senior Director for the Avoca Quality Consortium, will present highlights of the changes and answer all your burning questions in the 90-minute webinar ICH E6(R3) Essentials: A Draft Guidance Overview.
Harvey is the lead contributor to the recently released online resource Tracking the Revised ICH E6: A Side-by-Side Comparison of Revisions 2 and 3, which clearly explains the updates by comparing the old language from ICH E6(R2) side-by-side with the new language in ICH E6(R3). In this webinar, developed from the extensive knowledge gained and lessons learned while creating the resource, Harvey maps out the highlights of the completely reorganized guideline.
Webinar takeaways include explanations of:
- New and revised principles of good clinical practice
- Expanded investigator oversight responsibilities
- Expanded sponsor oversight responsibilities
- A new section on Data Governance
- A revised Essential Documents (Records) section
- And more!
The webinar, with or without the online tool, is a must-attend for investigators, sponsors, IRBs, IECs, service providers and teams — anyone who needs to understand and follow the evolving principles of good clinical practice.
Have confidence that you’re ready for successful implementation of the final R3 guidance.
Meet Your Presenter
Senior Director, Avoca Quality Consortium
Karen Harvey has 25 years of experience in healthcare and in the clinical research industry, including work as a registered nurse and in diverse roles within the clinical research industry at the site level and at CROs. She is well-versed in quality assurance and quality management oversight, with a focus on sponsor/CRO oversight and strategic relationships. As the senior director of the Avoca Quality Consortium, part of Avoca, A WCG Company, Harvey has a focus on building strong client relationships, content creation, and expanding client knowledge of WCG solutions.
This webinar is a special presentation from CenterWatch, A WCG Company