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News

Health Sciences Records and Archive Association > News > News
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Summary of MHRA GCP StEM

Posted on August 9, 2023August 9, 2023 by Administrator
On 18-Jul-2023, Jamie Toth (HSRAA Chair) attended the MHRA GCP StEM in Canary Wharf, London.  Karen Roy, CDISC TMF Reference Model Chair, also was in attendance along with 40 other representatives across industry and various sectors impacted by the ICH E6...Read More
Posted in News

CE Marking Recognition for Medical Devices and In Vitro Diagnostics

Posted on August 9, 2023August 9, 2023 by Administrator
The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics. Read in full HERE
Posted in News

EMA/HMA – Big Data Workplan 2023-2025

Posted on August 9, 2023August 9, 2023 by Administrator
The vision on Big Data is a strengthened regulatory system that can efficiently integrate data analysis into its assessment processes to improve decision making. Knowing when and how to have confidence in novel technologies and the evidence generated from Big...Read More
Posted in News

ICH Public Consultation: Real-World Evidence Reflection Paper

Posted on August 9, 2023August 9, 2023 by Administrator
ICH has published a new Reflection Paper: International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines The Reflection Paper (endorsed by the...Read More
Posted in News

OECD Advisory Document on GLP and Cloud Computing

Posted on August 9, 2023August 9, 2023 by Administrator
The OECD has published its Advisory Document on GLP & Cloud Computing - Supplement 1 to Document Number 17 on Application of GLP Principles to Computerised Systems, release date 29th June 2023. This document describes the expectations that GLP Compliance...Read More
Posted in News

Impact of ICH E6 (R3) on Clinical Trial Data Archiving

Posted on August 9, 2023August 9, 2023 by Administrator
ICH recently released a new draft of the ICH E6 (R3) guidelines. While the finalised version is set for release at the end of 2023, we can see what is expected to be published. The ICH E6 (R3) Guideline details the responsibilities...Read More
Posted in News

FDA Discussion Paper – Artificial Intelligence in Drug Manufacturing

Posted on August 9, 2023August 9, 2023 by Administrator
As FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, it has identified in this discussion paper areas for which public feedback would be valuable.  Read in full HERE
Posted in News

MHRA Update to Guidance on Borderline Products

Posted on August 9, 2023August 9, 2023 by Administrator
The MHRA has updated its published “Guidance on Borderline Products: How to Tell if your Product is a Medical Device and which Risk Class Applies”. The revisions comprises an additional section ‘Annex A – MHRA borderline determinations’ to assist manufacturers to...Read More
Posted in News

MHRA Changes to ICH E6 GCP Guideline

Posted on August 9, 2023August 9, 2023 by Administrator
Andrew Fisher, Lead Senior GCP Inspector, has written a blog about the changes to the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline now that the updated version R3 has reached Step 2b and is available for...Read More
Posted in News

EMA Questions and Answers about Raw Data Proof-of-Concept Pilot

Posted on August 9, 2023August 9, 2023 by Administrator
This newly published European Medicines Agency ‘Questions and Answers Document’ provides answers to commonly asked questions about the proof-of-concept pilot on the submission and analysis of ‘raw data’ from clinical studies as part of selected initial marketing authorisation applications and...Read More
Posted in News

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News

  • Summary of MHRA GCP StEM
  • CE Marking Recognition for Medical Devices and In Vitro Diagnostics
  • EMA/HMA – Big Data Workplan 2023-2025
  • ICH Public Consultation: Real-World Evidence Reflection Paper
  • OECD Advisory Document on GLP and Cloud Computing

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