News

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

There’s still time to register for the 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, FL for best practices, learning, networking, and career advancement opportunities. Agenda Register Here

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

Sarah Hitching (Hedian Records Management and HSRAA Member) will be presenting at the 2024 CDISC + TMF Interchange in Berlin (24th – 25th April 2024) on the subject of ‘How Have the Regulations Influenced Risk Based TMF Strategies?’ You can look up more about Sarah’s presentation under ‘Program’ on the 2024

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:    – Assess their current capabilities for digital preservation   – Identify where there are gaps    – Develop appropriate solutions  Find out

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.

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 2024 or until the conclusion of the next 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

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.

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

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

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 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