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ConsultationsConsultations Archive

Consultation on the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP) Guidelines

The ICH Expert Working Group (EWG) for ICH E6(R3) has been updating ICH E6(R2) GCP guidelines. The MHRA represents the Pharmaceutical Inspection Co-operation Scheme (PIC/s) in the EWG. The update is to address the application of GCP to new trial designs, technological innovations and to strengthen a proportionate risk-based approach of its application for clinical trials of medicines to support…
Dawn
June 2, 2023
ConsultationsConsultations Archive

ISO/PWI TS 6268-2 Health informatics — Cybersecurity framework for telehealth environments — Part 2: Cybersecurity reference models of telehealth

This document is the second part of the full series of ‘ISO TS 6268 Cybersecurity Framework for Telehealth Environment’, which provides telehealth cybersecurity reference models of the overall security framework for systems and services applied to telehealth. This document contains a general description of; - relationship of security risks and safety risks in telehealth services; - methodologies of defining the…
Ben Kemp
June 2, 2023
ConsultationsConsultations Archive

Results of the 10-Year Cancer Plan call for evidence

Here are some findings from the outcome of the 10-Year Cancer Plan consultation: 55% of individuals and 50% of professionals and organisations said that raising awareness of the causes of cancer and how it can be prevented should be prioritised over the next decade. 73% of individuals and 56% of professionals and organisations said that raising awareness of the signs…
Dawn
May 26, 2023
ConsultationsConsultations Archive

Amendments to the polychlorinated biphenyls (PCBs) regulations

Closes: 11:59pm on 30 June 2023 Consultation description We are seeking your views on a small number of proposed changes to the Environmental Protection (Polychlorinated Biphenyls and other Dangerous Substances) (England and Wales) Regulations 2000 (SI 2000/1043), as amended by the Environmental Protection (Disposal of Polychlorinated Biphenyls and other Dangerous Substances) (England and Wales) (Amendment) Regulations 2020 (SI 2020/489), (hereafter…
Dawn
May 26, 2023
ConsultationsConsultations Archive

Consultation on the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP) Guidelines

Consultation description The ICH Expert Working Group (EWG) for ICH E6(R3) has been updating ICH E6(R2) GCP guidelines. The MHRA represents the Pharmaceutical Inspection Co-operation Scheme (PIC/s) in the EWG. The update is to address the application of GCP to new trial designs, technological innovations and to strengthen a proportionate risk-based approach of its application for clinical trials of medicines…
Ben Kemp
May 26, 2023
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Government invites views on tackling major conditions in England

A call for evidence has been launched to invite views on how best to prevent, early diagnose, treat and manage the 6 major groups of conditions which drive ill health and contribute to the burden of disease in the population in England. The 6 major health conditions are cancer, cardiovascular diseases including stroke and diabetes, chronic respiratory diseases, dementia, mental…
Dawn
May 19, 2023
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