- ICH consulted Stakeholders To Modernise Global Good Clinical Practice Guidance, 12 January 2017
In January, The International Council for Harmonisation (ICH) announced the availability of its reflection paper on Good Clinical Practice (GCP) “Renovation”. ICH had invited the public to review and comment on this paper, which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of this proposed renovation includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice, which is already undergoing modernization with the recent production of ICH E6(R2).
The goal of this potential renovation was to provide updated guidance which is appropriate and flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions. The underlying principles of human subject protection and data quality would remain. ICH has decided to invite stakeholder’s comment on the proposed renovations at an early stage, ahead of guideline development efforts and also recognised the considerable stake and relevant expertise in the research community beyond ICH.
- Extension of the Remit for the Points to Consider Working Group (M1 PtC) to Develop and Maintain a Companion Document to the PtC Documents, 23 January 2017
The proposal was to extend the remit of the Points to Consider (PtC) Working Group (WG) beyond the development and maintenance and to allow the WG to develop and maintain an additional companion document to the existing PtC documents. The PtC documents provided valuable guidance to MedDRA users worldwide on general term selection and data retrieval principles as well as providing specific examples of approaches to coding and analysis. The PtC WG seeks approval for the extension of its remit by the ICH MedDRA Management Board to develop and maintain the companion document; however, it has proposed that the document itself would not need to be approved by the ICH Med DRA Management Board prior to initial release or prior to subsequent updates.
- Rules of procedure overview of the MedDRA Management Committee, 23 January 2017
MedDRA, the Medical Dictionary for Regulatory Activities, is an ICH product. The ICH Association is the owner of the intellectual property rights to MedDRA in all languages. The MedDRA Management Committee acts independently of the ICH Management Committee, and reports to the ICH Assembly. Further to Article 52 of the Articles of Association, these Rules of Procedures (RoP) of the MedDRA Management Committee are intended to provide guidance and interpretation in respect of the provisions of Articles of Association relating to the MedDRA Management Committee. In the event of discrepancy or inconsistency between the RoP and the Articles of Association, the latter will prevail. In such a case, the RoP should be amended to ensure that they are consistent with the Articles of Association. These RoP of the MedDRA Management Committee, in addition to the Articles of Association, shall be published on the website of the ICH Association. The Rules of Procedures of the MedDRA Management Committee will be adopted and amended in accordance with Article 48(2).
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