Training Implications of the ICH E6(R3) and E8(R1) Guidelines
Be prepared for ICH E6(R3): turn guidelines into real-world action. In this post, we delve into the key updates and training gaps.
May
2023
May
2023
A Comparative Review of the ICH E6(R3) and E8(R1) Guidelines
Unpacking the new ICH guidelines, E6(R3) and E8(R1), we illuminate their key elements, identify gaps, and compare the two in terms of their unity, differences, and complementarity.
Feb
2023
Reflections on ICH E6(R3): Insights from SCOPE Summit 2023
Exciting news on ICH GCP E6(R3) is here! Our CEO, Artem Andrianov, returned from the SCOPE Summit with updates on the updated guideline. ICH E6(R3) will incorporate technology advancements while prioritizing participant protection and reliable evidence. Don't miss Artem's thoughts on his experience at the summit. Stay tuned for more updates on ICH E6(R3)!
Apr
2022
ICH E8(R1) General Considerations for Clinical Studies
With the release of the final ICH E8(R1) version this month, sponsors and CROs are encouraged to embrace a Quality by Design culture. This final paper is part of a more general Good Clinical Practice (GCP) “Renovation” that involves the modernization of ICH E8 and subsequent renovation of ICH E6.
Oct
2021
Quality by Design | ICH E8(R1) General Considerations for Clinical Studies
The final version of the ICH E8(R1) guidance discourages the old-school "one size fits all" approach. Instead, risk-based quality management concepts such as QbD and CtQ factors predominate these modern-day considerations which encourage the biopharma industry to go beyond the traditional checklists. We've visualized the final 2021 guidance, "General Considerations for Clinical Studies," for you.
Jun
2017
ICH GCP Addendum E6 R2 comes into operation!
Today the ICH GCP Addendum E6 R2 comes into operation. Therefore, we summarized the useful resources for your kind perusal: GCP E6 R2 Addendum itself - http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf PDF Mindmap of all GCP E6 R2 changes - https://cyntegrity.com/ich-gcp-addendum-e6-r2-mind-map-pdf-for-download/ ICH GCP Goes Risk Based - a [...]
Nov
2016
ICH Finalized GCP Addendum E6 Revision 2
The ICH GCP Addendum E6 R(2) is final now! Global good clinical practice (GCP) guideline amendment adopted The 1996 ICH guideline on GCP is one of the most significant achievements of the ICH process, establishing harmonised standards for clinical trials. The ICH Assembly adopted [...]
Nov
2016
ICH E.2 (R2) – join our webinar!
ICH E.6 (R2) Scope of and need for Gap Analysis WEBINAR PROGRAM • ICH E.6 R2 History, Changes and Scope • Risk-based Quality Management • Quality Tolerance Limits • Risk-based Monitoring Plan • Examples • Gap Analysis • Electronic Media Validation • [...]
Aug
2016
ICH Recommends RBM for Multi-Regional Clinical Trials
On 6th May 2016, a draft guideline of the International Council on Harmonisation (ICH) “General Principles for Planning and Design of Multi-Regional Clinical Trials” was published, the aim being to make global multinational clinical trials safer and more trustworthy [1]. ICH advises applying a [...]
Jul
2016
ICH GCP Addendum E6 (R2) (Explanation Video from ICH)
[videojs width="640" height="480" mp4="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_Step_2_audio.mp4"] Source: http://www.ich.org International Council for Harmonisation (ICH) first time since 17 years is undertaking ground-shaking changes to Good Clinical Practice (GCP) guidelines. These changes take effect on November 1, 2016. In the 22 minute video above it is described how the new [...]