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.
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 [...]
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 [...]
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 • [...]
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 [...]
[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 [...]
by Artem Andrianov, PhD, Beat Widler, PhD, Maria Proupín-Pérez, PhD Originally published by Applied Clinical Trials Online Available: http://www.appliedclinicaltrialsonline.com/ich-gcp-goes-risk-based.
The pharma world is expecting a new regulatory "earthquake". GCP additions. The upcoming GCP addendum E6 (R2) by many experts is named already as "game changing". Clinical trial design, conducting, oversight, recording and much more is added now to GCP. Let [...]
ICH GCP Goes Risk-Based GCP Addendum Review and Embracement Plan by Artem Andrianov, PhD, Beat Widler, PhD, Maria Proupín-Pérez, PhD Web-View AppliedClinicalTrials, May 2015: The new upcoming GCP E6 (R2) addendum has the potential to reform clinical monitoring and clinical trial management. What changes [...]
