DARQA

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  • DARQA Spring Event 2026: AI in Practice across GCP, GLP and GMP

    Event language: This event was held in Dutch.

    DARQA, the Dutch Association of Research Quality Assurance, used its Spring Event 2026 to try something more ambitious than a standard themed meeting. Instead of treating AI as a narrow technology topic, it built a full-day combined GxP programme around AI in Practice: a moderated opening keynote, a plenary session on work and labour-market effects, parallel healthcare case presentations, and a collaborative workshop track for GCP, GLP and GMP professionals. The day was chaired by Victor Broers, who linked the sessions, moderated Q&A, and acted as the in-room anchor for the remote keynote. The event was explicitly framed as practical, applicable and “free of hype,” aimed at DARQA members as well as QA professionals, auditors, clinical research specialists and quality managers more broadly.

    The day as a whole: from AI enthusiasm to AI under control

    The strongest thematic thread was that AI is no longer mainly a question of technical capability. Throughout the day, speakers kept returning to judgment, context, evidence quality and workflow fit. Fabrizio Maniglio argued that quality professionals are moving “from knowledge worker to wisdom worker,” because AI can process information at scale, but human beings still carry meaning, ethical reasoning and accountable judgment. Sabrina Genz then showed that the real labour-market effects of AI cannot be reduced to “jobs disappear” or “jobs survive”; the decisive level is the task, not the job title. In the afternoon, Myrthe Jager and Peter Prinsen showed what this looks like in practice: AI becomes valuable when it is narrowly purposed, validated against a real need, and embedded in a real process, whether that is intraoperative tumor classification or nationwide cancer data structuring.

    The workshop track sharpened the governance side of the same message. Its central phrase — “digital sovereignty as continuity of GxP evidence” — turned a broad policy term into a concrete QA/QC question: when systems degrade, suppliers delay, formats lock you in, or records are challenged, can you still retrieve, understand and defend the evidence chain? The workshop succeeded because it translated AI readiness into evidence readiness. Participants repeatedly discovered that the weak point is often not the model, but the source record, the audit trail, the metadata, the export route, or the fallback path. That insight connected directly back to the rest of the day.

    A final recurring theme was the human side of change. DARQA did not end the day with another technical talk, but with Nancy Beers’ serious-play session, which made a strong point in a different language: if organisations want meaningful human oversight, they have to preserve and practise the human capabilities that matter — communication, reflection, focus, experimentation, collaboration and the courage to question assumptions. That made the close more than entertainment. It completed the day’s argument. AI may be accelerating rapidly, but regulated practice still depends on people who can interpret, decide, connect and act responsibly together.

    Opening keynote – Fabrizio Maniglio: The Wisdom Gap

    Fabrizio Maniglio opened the thematic programme by acknowledging the room’s uncertainty rather than dismissing it. AI, he argued, is moving faster than any technology wave before it, so confusion is understandable — but it is not too late. His starting point was that regulated industries are still at the beginning, provided they start learning now. From there he contrasted today’s extraordinary technical possibilities with the reality of paper-heavy, siloed, bureaucratic processes. His most memorable challenge was that many organisations are trying to attach AI to outdated workflows: “faster paperwork is still paperwork.” Instead of asking how to accelerate current processes, he urged the audience to ask what those processes are actually trying to achieve, and whether they would be designed in the same way from scratch today.

    The keynote’s key idea was the wisdom gap. AI is becoming increasingly strong at converting data into information and knowledge, but human beings remain responsible for judgment, meaning and accountable decision-making. In Maniglio’s formulation, quality professionals are evolving “from knowledge worker to wisdom worker.” He reinforced that with two strong cautions: first, Chesterton’s Fence — do not remove a control before you understand why it exists; second, do not hide behind symbolic “human in the loop” language if the human lacks the understanding, authority or time to exercise real oversight. In Q&A, he argued that regulators are unlikely to define every acceptable AI use in time, so industry must stop waiting passively and instead build justified, safe, fit-for-purpose solutions itself. On the question of tasks humans cannot realistically re-perform, he was equally clear: assurance must then come from model design, validation and intended-use control, not from pretending that a nominal reviewer can meaningfully verify everything afterwards.

    Plenary session – Sabrina Genz: AI, work and the changing workplace

    Sabrina Genz took the room from strategic reflection into labour economics, and she did so interactively. Using live polling, she asked participants first what opportunities AI offers and then what challenges it brings. The answers were revealing: opportunities clustered around efficiency, speed, focus and quality, while concerns clustered around validation, correctness, trust, safety, ethics, data security and acceptance. She used those responses as a bridge into her main theme: the real effect of AI on work is more complex than the public replacement narrative suggests. Her key line, in substance, was that we should think in tasks rather than whole jobs. Some tasks are automated, some are augmented, and the practical outcome depends heavily on which tasks move and in what context.

    Genz showed that new technology can both remove work and create new work. Drawing on occupation research, she noted that only about 40% of current US occupations existed in 1940, which means many of today’s jobs are historically new. She then unpacked how AI can lower barriers to entry in some jobs, as in her taxi-driver example, while making other jobs more knowledge-intensive, as in her proofreader example where spell-checking disappears and conceptual review remains. She also presented evidence that AI can raise productivity substantially in specific settings: around 40% faster on writing tasks and about 15% faster in customer support, with especially large gains for less experienced workers. That, however, brought the room to one of the day’s sharpest open questions: if AI can substitute part of junior learning in the short term, how do organisations still develop future experts in the long term? Genz did not overstate the evidence. Her strongest conclusion was that AI should not be rolled out everywhere by default. Productivity gains appear when the tool fits the task, the environment and the user — and that remains a design, governance and societal choice, not just a technical one.

    Track A – Myrthe Jager: From Molecules to Minutes

    Myrthe Jager’s session showed AI at two very different points in the oncology pipeline, which is exactly what made it so effective. Her title, “From Molecules to Minutes,” captured the arc: from early-stage, data-intensive molecular discovery to near-real-time clinical decision support. In the first half, she discussed the MIRSA project on melanoma resistance to immune checkpoint inhibition. The biological promise is high, but the data are sparse, expensive and difficult. Spatial transcriptomics can preserve tissue context and reveal where cells sit and interact, but the method costs about €15,000 per slide, takes significant time, and captures only a tiny fraction of the underlying transcriptomic signal. That is where AI becomes necessary: for segmenting cells, improving signal quality and eventually identifying patterns and biomarkers in data that are too incomplete for straightforward human interpretation.

    The second half of her session turned to Sturgeon, a much more mature and immediately tangible use case: ultra-fast brain tumor classification during surgery. Here the clinical problem is clear. Molecular diagnosis normally takes about a week, but surgical decisions have to be made immediately. The Sturgeon workflow combines nanopore sequencing with machine learning trained on simulated shallow sequence runs, allowing meaningful classification from extremely sparse data. Jager showed how practical this has become: a compact setup with a MinION sequencer, pipettes, heat blocks and even a gaming laptop can produce a diagnostic result within roughly 80 minutes, with the classification signal emerging earlier during the sequencing run. Most strikingly, she reported that the method is already in routine use at the Princess Máxima Center: more than 100 cases, a clear diagnosis in time in 85% of cases, and an adjusted surgical strategy in 14%. Her wider lesson was important for DARQA: useful medical AI is not generic AI, but carefully bounded, validated, translational work built on difficult data and real workflow discipline.

    Track A – Peter Prinsen: AI at IKNL and the Cancer Registry

    Peter Prinsen shifted the focus from molecular medicine to national data infrastructure. As head of Clinical Data Science at IKNL, he showed that some of the most important AI questions in cancer care are not about flashy models at all, but about the sustainability of data collection and structuring at scale. He introduced the Netherlands Cancer Registry as a nationwide asset with more than 95% coverage, data going back to 1989, around 2.5 million patients and 2.9 million tumors, and a large manual registration effort involving about 125 FTE. Much of the relevant hospital information still arrives in unstructured text and is abstracted manually months after diagnosis. Against a background of ageing populations, rising cancer incidence, more demand for data and pressure for greater timeliness, his message was blunt: this way of working is becoming unsustainable.

    Prinsen’s answer was practical rather than utopian. He outlined three broad routes for AI-supported structuring of oncology data: hospitals structure their own data; IKNL receives unstructured data and structures it locally; or IKNL brings the model to the hospital and structures data there in a federated way. What made his presentation especially relevant to DARQA was the emphasis on local control, privacy and digital sovereignty. For sensitive patient data, he argued, local models are essential — on premise, or at least on infrastructure not controlled by American cloud providers. He also described compute as a real bottleneck, with IKNL only now finalizing a two-GPU workstation for serious experimentation. His concluding line was a sober one: AI will probably not replace data managers, but it will change their work. Machines can collect the easier items; human experts then shift toward checking, resolving and interpreting the harder ones. In other words, AI here is not a replacement fantasy but an operational necessity that still depends on validation, secure deployment and well-governed data.

    Track B – Workshop: Digital sovereignty as continuity of GxP evidence

    The workshop track was the day’s most explicitly collaborative element, and also its most directly DARQA-shaped contribution. Instead of asking participants whether they preferred cloud or on-premise systems, it translated digital sovereignty into one operational question: can your organisation still produce fast, complete and defensible evidence when pressure hits? The workshop was designed around three cases — one each for GCP, GLP and GMP — and asked mixed groups to do what the facilitators called “data detective work”: map the evidence path, identify where the chain breaks, estimate the Mean Time To Evidence (MTTE), define a fallback route, and end with one sharp supplier or IT question and one 30-day action.

    What actually happened in the room was even more interesting. The opening became more dialogic than planned, because participants immediately connected the topic to AI, data quality, lineage, duplicated documents and the weakness of static exports. That turned out to be productive. The workshop’s central lesson became clearer precisely because the room insisted on the AI link: before trustworthy automation can exist, the underlying evidence path has to be visible and defensible. The three domain groups then surfaced different versions of the same problem. In GCP, the issue was evidential completeness across multiple SaaS systems and whether one subject file can be reconstructed on time. In GLP, the issue was whether archived PDFs are enough when the real challenge is still the original electronic raw data, processing parameters and legacy readability. In GMP, the issue was whether QA can still make a defensible release-or-hold decision when systems degrade and raw audit trails are incomplete. The workshop’s strongest line was also its simplest: AI readiness begins with evidence readiness.

    Future of DARQA

    Just before the closing session, DARQA briefly turned the lens on itself. Based on a member survey with 73 responses — about 26% of the membership — the association showed that it has a strong, experienced base, but also a clear renewal challenge: 92% of respondents had worked in the industry for more than 15 years. The board presented four priorities: stronger cooperation with other societies, renewal of activities, more active member involvement, and better communication. To support that last part, DARQA announced a new committee, Connect and Grow, and issued an open call for members to help strengthen visibility, communication and member connection.

    Closing session – Nancy Beers: Play to the Finish

    Nancy Beers closed the day by changing the mode without losing the seriousness. Her opening line was playful — she called herself the “infotainment” part of the programme — but her argument was practical: play in organisations is not a luxury and not “just fun.” It is a method for learning, reflection, innovation, collaboration and behavioural insight. Drawing on her background in game-based learning, IT and facilitation, she argued that innovative people are usually playful people: astronauts, hackers and builders all experiment, test boundaries and ask what else a system can do. She also made clear that play is not valuable because it is easy. One of her sharpest lines was that play is often “not about fun… it’s about frustration,” because frustration reveals habits, pressure points and team dynamics.

    Her games were chosen carefully. The Start/Stop exercise reset the room physically and cognitively after a long day. The Living Organization game turned organisational growth, hierarchy and communication loss into something visible, as participants discovered how quickly direction becomes distorted through layers and how rarely people think to communicate explicitly. The Black Stories puzzle exposed bias and assumption-making in a format that felt very close to investigation logic. Finally, Brainshock dramatized multitasking and overload by forcing participants to combine movement, maths and personal questions at once. The group response was strong throughout: laughter, recognition, useful discomfort and thoughtful debriefing. That last part mattered most, because Beers’ key closing line was that “a serious game is a serious game when you do a proper debrief. Because otherwise it was just fun.” In the context of an AI-focused GxP day, her session made a fitting final point: if organisations want better judgment and better collaboration, they must deliberately cultivate the human capabilities that machines do not automatically strengthen for them.

    Taken together, the DARQA Spring Event 2026 delivered what it set out to do: a practical, cross-GxP exploration of AI that avoided both hype and simplistic rejection. For attendees, it offered validation, challenge and useful language. For non-attendees, the main message is clear enough to carry forward: in regulated environments, the real question is no longer whether AI exists, but how to make its use understandable, defensible and genuinely useful in practice.

  • Report on the GLP Theme Day – Quality Meets Security: Bridging GLP Principles and IT Practice

    Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.

    Event language: This event was held in Dutch.

    On 28 November, DARQA’s GLP Committee organised a theme day on a topical subject: the connection between Good Laboratory Practice (GLP) and IT security. The event was prompted by the publication of the latest OECD document, No. 25, entitled “Good Laboratory Practice and IT Security”. As is customary when new OECD publications appear, the Dutch Health and Youth Care Inspectorate (IGJ) was also present.

    The meeting attracted around 50 participants, including new DARQA members and several visitors attending a DARQA event for the first time.

    Secure storage of GLP data

    The day began with a presentation by Frans Boeijen, who addressed the question: How do you safeguard electronic GLP data? He outlined the similarities between measures for paper and digital data and emphasised additional steps for optimal protection, such as incident recording, penetration testing, and backup and restore procedures, alongside familiar measures such as firewalls and antivirus software.

    Improving QA audits with OECD GLP Document No. 25

    John Cheshire of Headway Quality Evolution Ltd joined as an external speaker. He provided an overview of QA responsibilities in the various OECD GLP documents and explained the link with Document No. 25. He also offered practical questions that QA professionals can ask during audits based on this document.

    Cyberattack: what now?

    Frans Brouwer then guided the participants through a realistic scenario: a cyberattack on a GLP laboratory. Working in groups, they considered the steps needed to get “back in business” after such an incident. The session produced valuable insights into crisis management and recovery planning.

    Practical examples from the IGJ

    After lunch, IGJ inspector Mirjam Smeets presented a series of real-world examples of what can go wrong when electronic data are managed. It was an instructive overview that made clear just how crucial care and awareness are.

    Panel discussion: from patching to the human firewall

    All speakers, including Hans de Raad, took part in a lively panel discussion. Topics included:

    • How should differences between global and local User Requirement Specifications be handled?
    • What are the requirements for patching operating systems?
    • How should the frequency and scope of backups be determined on the basis of risk?
    • How can behavioural analytics support intrusion detection?

    The human factor also received considerable attention: many incidents are caused by human actions. Training and awareness are therefore indispensable—the “human firewall” is at least as important as technical safeguards.

    Q&A with the inspectors

    The concluding Q&A covered questions including the validation of Excel spreadsheets. The advice was to avoid Excel for generating GLP data, but to use it for analysing existing data only when it has been validated. The role of the Archivist in cloud storage and the importance of clearly allocating responsibilities between IT and archiving were also discussed.

    Main conclusion

    All presentations showed that IT security measures in GLP environments are primarily intended to reduce the risks of data loss or damage. Every organisation must be aware of these risks and take appropriate measures to achieve and maintain compliance.

    The day ended with informal drinks, providing ample opportunity to exchange knowledge and experiences—exactly as DARQA intended.

    Frans Brouwer

    Chair, GLP Committee

  • Report on the 2025 GCP Theme Day – Revision 3 of ICH E6 GCP

    Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.

    Event language: This event was held in Dutch.

    On 16 May 2025, the GCP Committee organised an informative and interactive theme day centred on Revision 3 of ICH E6 GCP. As announced beforehand, this was not a GCP training day, but a day intended for exchanging views on the changes brought about by implementing ICH GCP R3.

    The day was opened by DARQA chair Eveline Krijger. This was followed by a clear presentation on the history of R3 and the pillars on which the new version is built.

    After this introduction by Henrieke de Bie on behalf of the GCP Committee, the programme continued until lunch with two presentations entitled “Implementing R3: Where to Begin?” Michael Smith explained the implementation plan from a sponsor’s perspective, while Edith Schafsfoort discussed what R3 means for the investigator. Both presentations clearly showed that each party faces its own challenges and that the transition from R2 to R3 involves a great deal of thought and additional documentation. R3 frequently uses the terms “fit for purpose” and “risk based”; the study team must therefore document its considerations and rationale throughout.

    After lunch, QA’s perspective was addressed. Kees van der Ploeg explained how his organisation made choices concerning the implementation of risk-based QA.

    The plenary session was led by Joke van Wageningen, and the day concluded with a Q&A session featuring two IGJ inspectors. This Q&A was again chaired by the DARQA chair. DARQA members had been able to submit questions well before the event, and during the session the inspectors explained the IGJ’s view. It is important to note that R3 applies not only to studies started on or after 23 July 2025. The IGJ also expects organisations to demonstrate implementation activities for studies already under way.

    All in all, it was a dynamic and engaging day, which ended with enjoyable informal drinks.

  • Report on the 2025 GMP Theme Day – Impurities in the Spotlight: GMP’s Dirty Secrets

    Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.

    Event language: This event was held in Dutch.

    On 7 November 2025, impurities took centre stage during the annual GMP Theme Day, and several Dirty Secrets were revealed.

    One presentation addressed the development of a holistic Contamination Control Strategy using a CCS tool.

    Impurities also play an important role in the early development of a product. This was explained in greater detail from a CMC perspective. 

    Impurities can originate not only from the product itself, but also from manufacturing materials or primary packaging, entering the product in the form of Extractables & Leachables.

    After the break, the programme continued with a presentation on Elemental Impurities that included an enjoyable quiz. The winner went home with a delicious chocolate letter. 

    The selection and management of CMOs in relation to technology transfer were then discussed.

    Several presentations from the ECA conference on Annex 22 were summarised, prompting the question: is AI the future?

    The day concluded with an update on ICH Q5, followed by a case study and panel discussion on “Impurities in the Spotlight—GMP’s Dirty Secrets”.

    It was a successful day, offering insights from several perspectives into how to identify, reduce and prevent product impurities. 

  • Report on the GLP Committee Webinar – Principles in Practice

    Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.

    Event language: This event was held in Dutch.

    On Thursday 5 June 2025, around 25 people took part in an interactive webinar on applying the GLP principles in a QA professional’s day-to-day work. 

    After a brief round of introductions by the GLP Committee, the composition of the group was surveyed: how many years of GLP experience participants had, the fields in which they worked, and so on. 

    A large proportion of the participants had many years of GLP experience and worked mainly in biotechnology and pharmaceuticals. 

    Participants could then choose from five topics. Topic 1 was not selected. Each chosen topic was discussed in a breakout session, after which a short summary was presented to the full group. The feedback for each topic is reported below. 

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  • Report on the Programme Following the AGM, 11 April 2025 – Quality Within and Across the GxPs

    Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.

    Event language: This event was held in Dutch.

    We may think that we speak the same language when it comes to Quality Assurance (QA). But did you know that a “Principal Investigator” means something very different in GLP than it does in GCP? Did you know that GVP uses the term internal “audits”, while GMP uses “self-inspections”? Or that a “site” in GMP is completely different from a “site” in GCP?

    On 11 April 2025, more than 40 participants joined DARQA’s discussion on “Quality Within and Across the GxPs”. The meeting was intended to explore the similarities, while also celebrating the differences between the GxPs.

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  • Report on the DARQA GLP Theme Day, 29 November 2024

    Report on the DARQA GLP Theme Day, 29 November 2024

    Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.

    Event language: This event was held in Dutch.

    From Good to Great – GLP, Quality Assurance and Quality Improvement Tools 

    On Friday 29 November 2024, around 50 participants gathered at De Eenhoorn in Amersfoort for a GLP Theme Day about recent OECD GLP documents.

    Frans Brouwer, chair of the GLP Committee, set the scene with a roadmap that took us from the introduction of the OECD Principles of GLP in 1981 through several important milestones. These included the consensus document on the validation of computerised systems in 1995, which was updated as Advisory Document No. 17 in 2016. The consensus document on applying GLP to the management of multi-site studies, No. 13, appeared in 2002. In 2022, Advisory Document No. 23 on QA and GLP was published, together with Position Paper No. 24 on quality-improvement tools and GLP. The question was raised: where are we heading in the future, and what role will AI play in our daily lives and in life-sciences research?

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  • Report on the DARQA GMP Theme Day: New Product Introductions – Is Your Product Ready for the Market?

    Report on the DARQA GMP Theme Day: New Product Introductions – Is Your Product Ready for the Market?

    Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.

    Event language: This event was held in Dutch.

    Friday 15 November marked the DARQA GMP Theme Day, themed “New Product Introduction: Is Your Product Ready for the Market?”

    It was a successful day with many inspiring presentations.

    Thank you to all the speakers for contributing to this GMP Theme Day.

     

    DARQA GMP Theme Day, 15 November 2024

    From left to right: Jelte-Maarten Penninks PMP®, Ayla Tasoz, Nynke Brouwer, Alexander Bijman, Fija Lagerwerf, Martinus de Jonge, Hans (J.P.) De Koning (chair for the day), and Wen Liem.

    With thanks from the DARQA GMP Committee.

  • Report on GMP ATMPs: What Makes Them Different?

    Event language: This event was held in Dutch.

    This was DARQA’s first event dedicated to Advanced Therapy Medicinal Products (ATMPs). Speakers joined us not only from the Netherlands, but also from the United Kingdom and Sweden. Contributions from all DARQA committees gave the day a genuinely cross-GxP perspective.

    Hans de Koning ensured that the day ran smoothly and that everyone had an opportunity to ask questions.

    Christine Mitchell (ChrisalisQAdvice) gave a general introduction to ATMPs and their classification. She also shared practical tips on seeking advice from the EMA and finding general information on its website. She highlighted the need for risk assessment and a robust strategy throughout the drug-development pathway to avoid surprises and additional work later: “Begin with the end in mind” (Stephen Covey).

    Ion Tcacencu (Venn Life Sciences) gave an interesting presentation on the preclinical aspects. He likewise emphasised the need for a risk-based strategy and explained that specific animal disease models may be required. Although safety studies should be conducted according to Good Laboratory Practice, he noted that some products had received marketing authorisation even though not all studies had been performed at a GLP-compliant test facility.

    Flow cytometry is often used both to characterise ATMPs and to assess samples collected from participants during clinical trials. Marie Geerlings (Ardena) gave a very clear overview of how flow cytometry works and offered valuable tips for auditing this type of analysis.

    Thilo Buck (Progress Experts in Life Sciences) concluded the morning with a presentation entitled Good Manufacturing Practices and Beyond: Essential Regulatory Insights for ATMPs. Although specific GMP guidance exists for ATMPs, some grey areas remain, including how Annex 1 should be applied. He gave the audience an excellent overview of the different regulations that need to be considered.

    After lunch, we continued with the theme of manufacturing. Marc Kamp (Kite Pharma) presented real-life situations involving both ATMP manufacturing and the associated logistics and transport. These can be highly complex because ATMPs often involve personalised medicines and transport across the globe. It is essential to keep manufacturing time to an absolute minimum so that the treatment can be returned to the patient promptly.

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  • Safety Information from a GCP Perspective

     

    On Friday, 22 September 2017, a GCP/GPV training day was held with the subject: “Safety Information from a GCP Perspective“.

    The day started with a presentation on “Core concepts in pharmacovigilance auditing” by Marielle Keulen, Xendo. It was followed by presentations which covered different aspects of Safety information which included Reference Safety Information (RSI) from Clinical Trial and Post marketing perspectives, presented by Deepti Naik, PRA Health Sciences and Marielle Keulen.

    Pharmacovigilance aspects which one comes across during day to day GCP or during monitoring was presented by Deepti Naik in her presentation “Safety information at investigator sites” hereby linking GCP and GPV. Final presentation for the day was on “Reference Safety Information from a QA perspective” presented by Laurentiu Chitimia, Astellas. The day concluded with a Q&A session with the speakers of the day.

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