AMG Änderungsgesetz ICH-GCP Addendum Aktuelle Fragen zu GCP/AMG Referentin: Dr. Dagmar Chase (Clinrex GmbH) EU Clinical Trials Regulation 536/2014 • Definitions and Scope • Authorisation Procedure • Application Dossier Increase of site & scale of development, also the cost! It is the most significant revision to International GCP to date, and the new addendum ICH GCP E6 (R2) introduced 26 new items concentrated in the areas of data management, sponsor and investigator responsibilities. Change in approach to quality (risk) management (new concepts for quality of clinical trials) Evolution … We are pleased to announce that as of June 1 st 2017 this course has been updated to incorporate additional information from the latest International Conference on Harmonisation E6 (R2) Guidelines for GCP and re-named ‘ICH Good Clinical Practice E6 (R2)’ to reflect this update. Since 1996 adoption of ICH E6, clinical trials have evolved substantially. ICH E6 Amendment Emphasizes Risk Based Approaches in Clinical Trials . Dieses ICH GCP Leitlinien-integrierte Addendum bietet einen einheitlichen Standard für die Europäische Union, Japan, die Vereinigten Staaten, Kanada und die Schweiz, um die gegenseitige Akzeptanz von Daten aus klinischen Prüfungen durch die Regulierungsbehörden in diesen Ländern zu erleichtern. The ICH GCP E6 (R2) addendum came into effect in Europe on 14th June 2017. ICH Reflection on “GCP Renovation” January 2017 Page 2 quality. Español Français русский PORTUGUÊS Việt. With the new ICH GCP E6 Revision 2 Addendum finalised and needing to be implemented by 14th June 2017 in the EU, it is important GCP for Sponsors, CROs, study sites and GCP inspectors to understand the changes and how to update processes and procedures to ensure the new requirements are met and their organisations are ready for regulatory inspection. Details of this addendum can be found on the R&D website, with a link to the addendum document. Type of Harmonisation Action Proposed The action proposed is a full rewrite and reorganization of the ICH E6(R2) Guideline entitled Good Clinical Practice (GCP). Clinrex GmbH, D. Chase, Version 1, 2017 1 of 1 GCP Refresher: EU Clinical Trials Regulation inkl. Why do we need an addendum to ICH E6? CLICK HERE TO GET STARTED. Course Overview. This is followed by a discussion of the proposed structure for a future “renovated” E6 guideline that might better address the range of possible studies and data sources of interest, applying a risk-based approach to … 2019 Endorsed by the Management Committee on 18 November 2019. ICH E6(R3): Guideline for Good Clinical Practice . 4. Dated 17 November .