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2025 AGM Slides

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2025 AGM Minutes

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Whitepaper: Long Term Digital Preservation of GxP Health and Life Sciences Data

Whitepaper: Long Term Digital Preservation of GxP Health and Life Sciences DataThe HSRAA and Arkivum have worked together to create this whitepaper on how digital…

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A case study – The journey towards defining and implementing a global records retention policy

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Rewind the clock and take Trial Master File back to basics: The paradigm of maintaining simplicity while embracing technology

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5 Key Steps to Onboard a Digital Archive

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A Goldilocks approach to risk-based digital preservation of GxP data: not too hot, not too cold, but just right!

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Ask not for whom the bell tolls; is the death of the Records Manager near?

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Trusting the machines: Artificial Intelligence and Machine Learning opportunities and threats

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Demystifying Inspections

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Factors Affecting Inspection Readiness – a Comparative Case Study

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Records & Archiving – Keeping up with your vendors. Requirements and Realities of Outsourcing (Workshop)

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The Principles of Managing a GxP Archive (Workshop)

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Managing Data Integrity and Software Integrity in GxP Data Archiving

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Changing face of Data Integrity regulatory inspections

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Moving House? What to think about when establishing a GxP DataArchive

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Deciphering & Delivering on Data Migration

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Review of Archival and Records Regulations, Standards and Guidance: Program Kryptonite or Yellow Sun?

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CDISC TMF Reference Model – the benefits of becoming a standard for long term records retention and clinical trial reconstruction

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Transforming patient records into dynamic medical digital twins to unleash the age of precision medicine

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Records Management in 2025

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Your New Best Friend, The System Record Assessment

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The Future of Records Management: Addressing Proprietary Data and the Retention-Archive Mystery

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Engage in Conversation with a Records Retention Schedule!

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When to Say “That’s a Wrap” to your Trial Master File (TMF)

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A unified approach to requirements specification, qualification and validation of archiving and preservation solutions that makes everyone happy!

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Interactive Roundtable

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Digital Archiving in Business Continuity Planning

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Selecting an eArchive Vendor

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Implementing Risk-Based Approach to Records Management in Compliance with R3 Regulation: A Strategic Perspective

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The EU CTR and its Impact on the Records

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The State of Clinical Research in the UK

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“A Quiet Place:” Mitigating Risks during GxP Transfers and Migrations

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Technical Information Governance & AI in Migrations across the GxP space

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CDISC TMF Reference Model Risk Management Project

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Digital Records: A new era in clinical records management

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Digital Health Technologies (DHTs) & the Impact to Records & Retention

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Data Dynamics: Mastering GxP Migration in the Pharma Industry (Workshop)

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GxP-Regulated Archives and the GxP Archivist (Workshop)

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Beyond Storage: Transforming Health Sciences Archives with AI, Machine Learning, and NLP

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2024 AGM Minutes

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2024 AGM Slides

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2023 AGM Minutes

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2023 AGM Slides

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Guidance Document on TMF Relevant Communications, published June 2009

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Selecting a Commercial Records Storage Provider, published March 2012

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Reconciliation of issued, used and un-used CRF books/modules/pages

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EFGCP Guidelines for retention of records at investigator sites, 2002 edition

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Guidance on the Scanning and Destruction of Original Paper eTMF Records, published April 2017

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An Assessment of the Impact of Regulation EU 536/2014 on GCP Records Management, published May 2015

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2021 AGM Minutes

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2020 AGM Minutes

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2019 AGM Minutes

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2018 AGM Minutes

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2017 AGM Minutes

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2016 AGM Minutes

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2015 AGM Minutes

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2014 AGM Minutes

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2013 AGM Minutes

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2022 AGM Minutes

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Objectivity in Science

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Data Chains of Custody – looking back… and then beyond for impact

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How to Craft Effective Policies and Standard Operating Procedures

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Data Integrity Risk – it’s not as complicated as you think

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A Risk-based Approach to Records Management: How Much Risk is Too Much?

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New EU Medical Device Regulations – Operational and Regulatory Compliance Considerations

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Information Asset Management – A Methodology

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Artificial Intelligence, Big Data, Deep Learning – What is it and what do record managers need to consider?

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Driving Content Intelligence – Curing Information Headaches

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Long Term Data Integrity: how digital preservation can help achieve regulatory compliance

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Moving to a Digital Landscape – bringing auditors along with us on the journey

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The intersection of information Management and Cybersecurity – Opportunities for Synergy

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How definition drift damages data

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Sagacity 1998/01

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Onrecord January 2022

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