Day 1 - July 15

eTMF Archiving Challenges: Bridging the Gap Between Trial Close-Out and Inspection Readiness

Cornelia Baumgartner, Cetacea - GxP Retention and Data Management

10:00 - 11:00 BST - July 15

This session will explore common mistakes organisations make when archiving electronic Trial Master Files (eTMFs) and how to avoid them. Attendees will gain practical guidance on structuring eTMFs to ensure long-term accessibility, simplify future retrieval, and maintain inspection readiness.

Building a Digital Preservation Advisory Unit: Beginnings, Lessons, and Use Cases

James Baker & Laurisa Sastoque, University of Southampton - Digital Preservation Good Practice

10:00 - 11:00 BST - July 15

How can an advisory unit support and respond to the evolving needs of digital preservation professionals across the cultural heritage sector? Digital Preservation Southampton, a flagship enterprise unit at the University of Southampton, launched in January 2025 with the aim of providing guidance, training, and strategic support for organisations in implementing digital preservation good practice. Our launch was the culmination of a multi-year effort to map sector-wide needs and design an enterprise model tailored to address them.

Quality Checks in GxP Archiving: The Hidden Steps You Can’t Afford to Miss

Sarah Hitching, Hedian Records Management - GxP Retention and Data Management

13:00 - 14:00 BST- July 15

In this session, Sarah will explore the critical but often overlooked role of quality checks in GxP archiving. Drawing on her experience working with global biotechs and as an active member of CDISC and the HSRAA, she’ll share real-world insights into regulatory expectations, common pitfalls, and practical steps to strengthen the integrity and compliance of your archived records.

EOSC EDEN: Adding Forever to FAIR

Matthew Addis, Arkivum - Digital Preservation Good Practice

13:00 - 14:00 BST - July 15

In this session, Matthew will talk about the EOSC EDEN project and the work it's doing on digital preservation for Trusted Digital Repositories and Archives in the European Open Science Cloud (EOSC). Some examples of current work in EDEN includes identifying the core preservation processes involved, how to assess whether repositories and archives provide the necessary services for long-term retention and access to digital objects, approaches to appraising and re-appraising data quality throughout the archiving lifecycle, and how to achieve interoperability when exchanging digital content with repository and preservation services. Read more.

Supporting Digital Preservation Good Practice - A Community Perspective

Jenny Mitcham, Sarah Middleton, Digital Preservation Coalition - Digital Preservation Good Practice

15:00 - 16:00 BST - July 15

In this presentation, the Digital Preservation Coalition (DPC) will discuss what Good Practice looks like in the context of their work. The talk will include an introduction to the DPC, their work with the digital preservation community and how to get involved. They will share some reflections on what 'good practice' means in the context of digital preservation and discuss resources and work underway to support the community in applying good practice. This will include a brief introduction to DPC's Rapid Assessment Model (DPC RAM) - a digital preservation maturity model which encapsulates community good practice and facilitates continuous improvement.

Cross-Functional Collaboration in Archiving Strategy

Ashley Avery, Global BioPharmaceutical Company - GxP Retention and Data Management

16:00 - 17:00 BST - July 15

Effective digital archiving in the life sciences industry requires more than just technology—it demands seamless coordination across multiple departments. This session will explore how Clinical Operations, IT, Quality Assurance, Regulatory Affairs, and Legal must align to create a robust, sustainable, and compliant archiving strategy.

ICH E6(R3) & TMF Oversight: What Story Does the Data Tell About Your Study?

Al Pacheco, Just in Time GCP - GxP Retention and Data Management

17:00 - 18:00 BST - July 15

Recognise the TMF as the window into the study and what it might say about the overall quality. Understand new ICH E6(R3) expectations for data integrity, essential records, and long-term accessibility, as well as deadlines for adoption. Evaluate the impact of R3 on the TMF and oversight approaches and what changes are necessary. Align TMF with study plans, SOPs, and regulatory requirements—ensuring it meets governance expectations and storage needs. Review recent industry trends, insights, and lessons learned from real-world experiences.

Day 2 - July 16

GxP Systems Decommission

Jean Maxime Pommery, Idorsia - GxP Retention and Data Management

10:00 - 11:00 BST - July 16

This presentation covers the intricate processes surrounding the decommissioning and archiving of GXP regulated computerised systems, addressing compliance, regulatory frameworks, methodologies, and best practices. We will delve into the criticality of maintaining data integrity and how effective archiving practices safeguard data security.

PreservACTION: a Long Term process.

Ombretta Finocchiaro, Deda Tech - Digital Preservation Good Practice

10:00 - 11:00 BST - July 16

The speech tries to expose the borders between what Long Term Digital Preservation is and what is not. The actual challenge is to rationalize and prepare the information enclosed in our data from the very beginning to the hypothetical dismission that will happen in a technical and cultural environment that we can only imagine now.

The focus becomes what we can do to be a part of this ongoing process that is required to be versatile and that involves experts from so many different domains to be effective and tailored on specific needs. A little mention of the standards we need to be aligned to in order to speak the same “digital language” and to be as interoperable as possible.

Regulatory Submissions Heritage: New Scenarios in eCTD Archiving and Preservation for an Effective Long-Term Usage

Roberta Svanetti, Deda Tech - GxP Retention and Data Management

11:00 - 12:00 BST - July 16

As regulatory scenarios change and users increase the weight attributed to the ability to use data, records, documents and more generally information and added value, Life Sciences companies see the complexity of managing submissions added to their commitment to digital preservation, against the inevitable technological obsolescence and with a key focus on sustainability. Read more.

From Paper to Pixel: Evolving Strategies for Research Record Preservation

Sandra Blake, Barts Health NHS Trust - GxP Retention and Data Management

12:00 - 13:00 BST - July 16

How to get from a paper-only record storage system to a hybrid one, with the aim to becoming fully digital. This session will cover the challenge of meeting records management best practice (from a qualified records manager's perspective) whilst also meeting NHS and research standards. Sandra will speak about advocating for digital preservation in an organisation that is not a memory institution and the common misconceptions that she has encountered. Sandra will finish by explaining how her new service aims to assist the wider NHS to improve and evolve its preservation of digital closed study records, and why.

The Digital Journey: Successfully Migrating Your Data to an Archive

Antonia Witten, Arkivum - Digital Preservation Good Practice

14:00 - 13:00 BST - July 16

Whether you're in healthcare, research, higher education, government, or the cultural heritage sector, migrating data to a digital archive is a critical step toward ensuring long-term access, compliance, and preservation. Yet the process can often seem daunting, involving multiple stakeholders, legacy systems, and complex regulatory requirements.

In this session, Antonia Witten, Customer Delivery Manager at Arkivum, will guide you through the entire digital migration journey. Drawing on real-world experience from a range of sectors, she will outline the key stages of a successful migration, from early planning and data assessment through to validation, implementation, and ongoing preservation.

The Challenges of Archival of Records in Multiple TMF Repositories

Dawn Niccum, inSeption Group - GxP Retention and Data Management

15:00 - 16:00 BST - July 16

With archiving timelines of upwards of 25 years, ensuring the maintenance of all TMF Repositories can pose challenges. The archivist must orchestrate the periodic review for the life of the records. This presentation will discuss typical long-term TMF repositories, the challenges in maintenance of the records, and strategies for working with the repository owners.

Day 3 - July 17 - Good Arkivum Practice