News
GxP Archiving and GxP Records Management News. Keep up to date with the latest news from HSRAA
Microsoft IM Tech Summit Europe 2024
HSRAA members might be interested in the forthcoming event on Microsoft 365 in Brighton on 15th May. Explore the potential of Microsoft 365 through an Information Governance and Data lifecycle Management lens. Find out more about the event here: www.imtech365summit.com Booking by 15th March gives attendees full access to all
Survey: How Have the Regulations Influenced Risk Based TMF Strategies?
Sarah Hitching (Hedian Records Management and HSRAA Member) will be presenting at the 2024 CDISC + TMF Interchange in Berlin (24th â 25th April 2024) on the subject of âHow Have the Regulations Influenced Risk Based TMF Strategies?â You can look up more about Sarah’s presentation under ‘Program’ on the 2024
Achieving Long-Term Data Integrity Using Digital Preservation
Arkivum have published a new eBook on “Achieving Long-Term Data Integrity Using Digital Preservation”. The eBook maps the ALCOA+ principles with self-assessment frameworks and maturity models, thus enabling organisations to:Â Â â Assess their current capabilities for digital preservation â Identify where there are gaps â Develop appropriate solutions Find out
Artificial intelligence workplan to guide use of AI in medicines regulation
The EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks. Read the workplan in full here.
GMP & GDP Certificates: Validity Period Extended
The Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate have posted a new blog post covering the extension of the validity date of GMP and GDP certificates. The validity was extended until the end of 2023, but has now been extended until 2024Â or until the conclusion of the next inspection,
Montrium: Hereâs How I Would Design the Perfect Mock Inspection
Christina Mantzioros at Montrium has put together a blog piece that goes over how mock inspections can help your team, and the steps they would follow to plan the mock inspection of their dreams. In this blog, Christina covers what mock inspections are, how they’d plan a mock inspection, how to
FDA – Translation of Good Laboratory Practice Study Reports: Questions and Answers
The Food and Drug Administration (FDA) have released a new guidance document. This draft guidance is not for implementation, it has been distributed for comment purposes only. The guidance provides information for sponsors and nonclinical laboratories regarding the language translation of study reports for studies conducted in compliance with good
MHRA – Medical devices: information for users and patients
The Medicines and Healthcare products Regulatory Agency (MHRA) have released updated information and guidance on a range of medical devices for users and patients. Visit the gov.uk website here to read the updated guidance.
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
CE Marking Recognition for Medical Devices and In Vitro Diagnostics
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
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
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
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
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
FDA Discussion Paper – Artificial Intelligence in Drug Manufacturing
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
MHRA Update to Guidance on Borderline Products
The MHRA has updated its published âGuidance on Borderline Products: How to Tell if your Product is a Medical Device and which Risk Class Appliesâ. The revisions comprises an additional section âAnnex A â MHRA borderline determinationsâ to assist manufacturers to arrive at the appropriate classification for their products. Read in
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
EMA Questions and Answers about Raw Data Proof-of-Concept Pilot
This newly published European Medicines Agency âQuestions and Answers Documentâ provides answers to commonly asked questions about the proof-of-concept pilot on the submission and analysis of âraw dataâ from clinical studies as part of selected initial marketing authorisation applications and post-authorisation applications submitted to the European Medicines Agency. The document