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GxP Archiving and GxP Records Management News. Keep up to date with the latest news from HSRAA

Summary of MHRA GCP StEM

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 (R3) changes.  The group in attendance had the opportunity to

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EMA/HMA – Big Data Workplan 2023-2025

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 Data will benefit public health by accelerating medicines development, improving

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ICH Public Consultation: Real-World Evidence Reflection Paper

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 Assembly in June 2023) presents opportunities for development of new

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OECD Advisory Document on GLP and Cloud Computing

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 Monitoring Authorities have of GLP test facilities which use cloud-based

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

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 of those involved in clinical trials to ensure the safe

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MHRA Update to Guidance on Borderline Products

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 arrive at the appropriate classification for their products. Read in

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MHRA Changes to ICH E6 GCP Guideline

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 public consultation.  Read in full HERE

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

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 post-authorisation applications submitted to the European Medicines Agency. The document

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Digital Preservation Coalition: Digital Preservation Policy Toolkit 2.0

An updated version of the DPC’s Preservation Toolkit has been shared, which improves the previous version by building on the work and feedback of their community. This toolkit offers information and resources to help you understand more about digital preservation requirements, practical steps for analysing your digital records and helpful

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FDA Bioresearch Monitoring (BIMO) Inspection Metrics 2022

The FDA has released its BIMO inspection metrics for year 2022. These metrics give you useful information on inspections performed throughout 2022 and observations raised (compared to previous years). With more inspections due to be conducted this year, get inspection ready and take a look at these findings, by clicking

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