News
GxP Archiving and GxP Records Management News. Keep up to date with the latest news from HSRAA
Registration now open for TMF Week 2025
Taking place from June 9th-13th, TMF Week 2025 featuresĀ an action-packed week of education and fun. With over 25 sessions covering a range ofĀ TMF topics from leading experts, book your place today for one of theĀ largest gatherings of TMF professionals.Ā Find out more here: https://www.tmfweek.com
2025 CDISC + TMF Europe Interchange
Conference: 14-15 May | Trainings: 12, 13, 16 May The 2025 CDISC + TMF Europe Interchange will take place in Geneva, Switzerland. The event will consist of workshops, training courses, and a two-day main conference for attendees to enjoy. It provides an opportunity to share progress, implementation experiences, and strategic
Cencora – Trial Master File Leadership Summit
Register today for the TMF Leadership Summit, taking place April 1st-2nd 2025 at Cencora’s Global Headquarters. The TMF Leadership Summit is a unique opportunity to connect with industry experts, explore cutting-edge innovations, and strengthen your network within the Trial Master File community. This event promises to deliver valuable insights and
Montrium – Call for Abstracts for TMF Week 2025
The call for speaker abstracts for the 6th annual TMF Week conference are now open. The conference will be taking place from June 9th-13th 2025. The Montrium website below covers ideas for topic areas, the new for 2025 exclusive FDA focus day, and experimenting with different presentations formats. Deadline to
Arkivum – Webinar Recording: eCTD Retention and Archiving
This recording from Arkivum delves into key regulatory requirements for retention of eCTD such as ICH E6 (R3), provides an overview of eCTD standards and data formats, and explores archiving eCTD including how eCTD records can be viewed and navigated in an archive environment. Find out more: https://arkivum.com/webinars/webinar-recording-ectd-retention-and-archiving/
What’s next for the ISF Reference Model? Presented by Montrium
In episode 23 of Montrium’s āState of the TMFā, Paul Fenton-Carter (Montrium), Jamie Toth (BeiGene & HSRAA), and Matt Lowery (The Pathways Group) discuss their work on the new ISF Reference Model. Watch here: https://www.youtube.com/watch?v=VFJa2sUbU3c
NEW Arkivum eBook on ICH E6(R3)
Following the publication of the finalised version of ICH E6 with the revision 3, Arkivum have created a free eBook titled “ICH E6(R3): What does the finalised guidance say about record retention?”. With the ICH E6 publication covering a broad range of topics, Arkivum have designed a guide that focuses
Itās 10 years of eArchiving: Reflections and insights for the next decade!
The eArchiving InitiativeĀ hosted an event back in May to celebrate the tenth anniversary of the first E-ARK project funded by the European Commission. During the event, the milestones of the last ten years, and the challenges of electronic archiving and digital preservation for the next decade were discussed. Read the
IRMS Online EventĀ
The IRMS’ upcoming online event “MMUās journey from shared drives to M365 ā an update” will take place on Wednesday 10th July at 13.00 BST. Nicki Hargreaves from Manchester Metropolitan University will speak about MMU’s journey from shared drives to M365, following a 14-month project to decommission a huge legacy
Arkivum – āArchivedā: A dangerous word in the world of digital preservation
A recent article published by Arkivum explains why the word “archived” is dangerous and poses risks to many modern businesses. The article looks at risk of damage or loss, long-term legibility, and the danger of āarchivingā without archiving. Read it here.
TMF Week 2024
TMF Week 2024 by Montrium will take place from the 10th-14th June 2024. The event will see a packed agenda with over 40 expert speakers and 20 insightful sessions across the 5 days, showcasing the latest trends, innovations, and best practices in TMF. Join this fully virtual conference experience to
The Digital Preservation Coalition (DPC) Novice to Know-HowĀ (N2KH): Building a Digital Asset Register
This short course aims to help learners with planning, building, and maintaining a Digital Asset Register, a key resource for managing the preservation of digital content. The three learning objectives of this course are: 1. Explain what a digital asset register (DAR) is 2. Prepare and plan for building a
The 2024 AGXPE Conference
There’s still time to register for theĀ 2024 AGXPE Conference, a pivotal event for quality and GxP training pros. Join the event from April 14-17, 2024 at the Westin Tampa Waterside in Tampa, FLĀ for best practices, learning, networking, and career advancement opportunities. Agenda Register Here
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.comĀ 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 ā 25th April 2024) on the subject of āHow Have the Regulations Influenced Risk Based TMF Strategies?ā You can look up more about Sarah’s presentation under ‘Program’ on theĀ 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:Ā Ā ā Assess their current capabilities for digital preservation ā Identify where there are gaps ā Develop appropriate solutions Find out
Artificial intelligence workplan to guide use of AI in medicines regulation
The EMA and theĀ Heads of Medicines AgenciesĀ (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 2024Ā or until the conclusion of the next inspection,