PharmaSchool Regulatory Updates

PharmaSchool GCP & Regulatory Updates are notifications about changes, additions and new documents relating to the conduct of Clinical Trials. These are updated as and when new information is available. If you know of a document that should be referenced in this section then please let us know by emailing editor@pharmaschool.co

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Date: 15 June 2017
Document: Annual report of the Good Clinical Practice Inspectors Working Group 2016
Region: International
Description: This document summarisies the findings in EMA requested inspections which were carried out in 2016, and also summarises the activities of the GCP Inspectors Working Group during this time.
URL: click here
Date: 01 January 2017
Document: ICH Reflection on “GCP Renovation”
Region: International
Description: ICH Statement on the ongoing revision of ICH clinical trial guidances starting with E8, General Considerations for clinical trials and continuing with likely further revision of E6, Good Clinical Practice.
URL: click here
Date: 01 November 2016
Document: ICH E6 (R2)
Region: International
Description: Integrated Addendum to ICH GCP guidance
URL: click here
Date: 29 January 2015
Document: ICH E2B (R3) Q and A document
Region: International
Description: ICH have issued a Q&A document on use of the ISO standardon Individual Case Safety Reports. The document provides guidance on completion of specific sections and other questions which have been raised.
URL: click here
Date: 02 December 2014
Document: ICH press release
Region: International
Description: The ICH Steering Committee are working to reform ICH with a view to creating a legal entity under Swiss law. Also the working party set up to develop the addendum to ICH GCP have made good progress and a step 2a (technical) document is expected in June 2
URL: click here
Date: 15 August 2014
Document: ICH GCP E6
Region: International
Description: ICH E6 should be supplemented with additional recommendations to facilitate innovative approaches to GCP to better ensure data quality and human subject protection in an environment of highly complex multinational trials
URL: click here
Date: 02 June 2014
Document: ICH GCP Proposed Addendum
Region: International
Description: THe ICH Steering Committee have appointed an expert working group to develop and addendum to ICH GCP: "To keep pace with the scale and complexity of clinical trials and to ensure appropriate use of technology we should modernise our approach to GCP to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality." The addendum is expected to be finalised in late 2016.
URL: click here
Date: 01 October 2013
Document: Declaration of Helsinki
Region: International
Description: The World Medical Association has updated this document at their meeting in Brazil. There is an article in the Journal of Clinical Research summarising the main changes.
URL: click here
Date: 01 July 2013
Document: ICH E2B (R3)
Region: International
Description: ICH has taken the decision to collaborate with the ISO standards developers for some of its guidance and E2B is the first document to be harmonised under this process. You can find the implementation guide on this page.
URL: click here

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