RQA and Sponsor Conference Opening

Kicking off the conference, this opening session—led by our Chair, Vice Chair, and Platinum Sponsor—will set the tone for the days ahead, exploring this year’s theme: Quality that Works – Pragmatism over Perfection.

KEYNOTE - Profits, Pragmatism and the Possibilities of Possessing 'Other Eyes'

The value of profits as an ingredient for organisations to sustain and develop their operations is undeniable. Thinking beyond the design and development of the next iProduct, profits allow for improvements to current products, not to mention needed technology upgrades, employee development, and dividends for shareholders. But, do organisations solely exist to earn profits or meet financial goals, or, are their profits the result of how well they invest their resources, from innovation to revenue and equipment, and then deliver new and improved products or services? W. Edwards Deming saw profits as the result of a well-designed and managed organisation. Contrary to the dominance of the prevailing style of management, Dr. Deming saw vast possibilities for individuals to work together, possessing 'other eyes'. 

About Bill:

Bill Bellows is a 35+ year specialist in the fields of Quality and Engineering Management.   In addition to his roles as an Adjunct Professor for California State University, Northridge and Southern Utah University, he serves as President of InThinking Services, partnering with clients to facilitate both the understanding and application of the Deming philosophy and integrating this philosophy within a greater framework of 'better thinking about thinking', a concept known as 'InThinking'.  His career includes 26 years of employment with Rocketdyne, the world’s premier liquid rocket engine company, providing leadership for 'InThinking'.   

Upon retiring from Rocketdyne, Bill joined The W. Edwards Deming Institute® as Deputy Director to share his lessons learned within a worldwide Deming community.  He is currently employed in the space business as a Senior Technical Advisor to the aerospace company, Blue Origin.  He earned his BS, MS, and Ph.D. in Mechanical Engineering from Rensselaer Polytechnic Institute in Troy, New York.  Away from work, Bill serves as a member of the Deming Medal Committee for the American Society of Quality and was a founding member of the editorial board of the Lean Management Journal, as well as co-founder of the In2:InThinking Network.

Through a thought-provoking question and answer session, attendees will be asked to question the context of their own observations and the resulting pragmatism of efforts to improve teamwork in their organisations.

Beyond the Deadline: GxP Compliance After Windows 10 Support Has Ended

Summary

Windows 10 security support officially ends (or already ended depending on when you're reading this!) on 14 October 2025; however, many regulated companies will still be navigating their path to compliance and seeking straightforward and pragmatic solutions to keep their data and systems secure. This session explores strategies for managing GxP expectations whilst dealing with legacy systems and GxP risks introduced following the end of Windows 10 support. We’ll discuss practical approaches to risk mitigation, vendor engagement, and documentation to support ongoing compliance - even when ideal solutions aren’t immediately available.

Learning Objectives

• Understand the compliance impact of operating unsupported systems in a post-deadline landscape.
• Learn how to build a defensible, risk-based rationale for continuing to use Windows 10 and gain confidence in explaining and documenting your approach during inspections.
• Explore practical technical and procedural controls that can mitigate risks while modernisation is in progress.

WORKSHOP: The Decline of Quality in PV Auditing - Missed Opportunities and Turning the Page

Summary

Pharmacovigilance (PV) audits are an essential (and legally required) tool for PV system improvement – yet its quality and impact are quietly declining by superficial and poor execution, and lack of real-PV operational relevance.

This workshop examines the slow erosion of PV audit quality into a state of “blah-ness” driven by factors like inadequate scoping, lack of operational PV experience among auditors, checklist dependency, and disproportionate focus on audit narrative over actual findings. In many organisations, audits have become ritualized rather than insightful - resulting in missed risks, duplicated efforts, and disengaged stakeholders. At the same time, the rise of AI and automation introduces new challenges that the current PV audit approach is ill-equipped to fully address. Through real-PV audit case examples support, interactive peer discussions, and facilitated practical strategies for reinvigorating PV audit.

This workshop will help participants reimagine PV auditing as a meaningful driver of quality and compliance. Attendees will gain tools to spot and address key pitfalls, evaluate their own PV audit practices, and begin building the capabilities needed to audit in an AI-enabled environment. This workshop is for anyone ready to move beyond audit fatigue and turn the page toward smarter, more impactful PV auditing.

Learning Objectives

1. Spot common signs of poor-quality PV audits and understand how surface-level PV practices can undermine PV compliance, insight, and continuous PV system improvement.

2. Evaluate the strategic value of own PV audits, using risk based thinking and developing system-focused assessment approach.

3. AIXiety in PV auditing - develop a plan on dealing with technology advancement and create practical, forward-looking roadmap to adopt auditiing skills, methods and mindset.

Quality by Design 20 Years On - Why Aren't we all Experts by now?

Summary

Quality by Design often summons up the image of a sleek, shiny, perfectly optimized trial which will proceed smoothly from conception to data analysis.  The reality at the coal face of pharmaceutical development is often quite different, as evidenced by multiple protocol amendments, lagging recruitment targets and budget overspends. This interactive session will look at key concepts in QbD which are often overlooked. We will explore the extent to which these have been adopted and consider practical tools to improve QbD practice and implementation.

Learning Objective

1. Exploring some of the more abstract components of Quality by Design in ICH E8(R1) such as quality culture and stakeholder engagement.

2. Examining why these are essential to successful adoption of QbD.

3. How data flows can help us to implement key aspects of QbD and facilitate risk-based approaches.

Case Analysis of PMDA GCP Inspections and Comparison with Other Regulatory Inspections by JSQA

Summary

The Japan Society of Quality Assurance (JSQA) is dedicated to improving the quality of clinical trials. JSQA is regularly analysing PMDA GCP inspection finding cases. Through this analysis, the JSQA identified remarkable points in findings, performed root cause analyses, and developed potential CAPAs for prevention of recurrence of similar issues. Our analysis sources were obtained by means of information disclosure requests to PMDA. This presentation will highlight the PMDA GCP Inspection overview, key PMDA GCP inspection findings and effective CAPAs drawn by JSQA, and comparative analysis of similar cases from recent US FDA Warning Letters. By sharing these insights, we aim to enhance the preparedness of clinical trial sponsors for regulatory inspections. Our work is particularly relevant for ensuring the successful completion of NDA submissions in Japan, where PMDA inspections are an important milestone. Furthermore, providing the presentation at RQA, we'd like to enhance and contribute to improving the quality of clinical trials globally. This presentation includes contents published in JSQA GCP training event.

Learning Objectives

Thought this session, the delegates will learn

• PMDA GCP inspection overview,
• Recent trends and cases of PMDA GCP inspection findings which analysed by JSQA,
• Remarkable points for CAPAs to prevent recurrence of similar issues.
• JSQA would expect the delegates to enhance and contribute to improving the quality of clinical trials, after attending this session.

Trust but Verify: Implications for Working Relationships

Summary

The clinical trial enterprise seems to be built on a foundation of mis-trust, with the endless layers of quality control, quality assurance and even inspections, ensuring that we meet regulatory requirements and the various other guidelines and standards of good practice. Inter-organisational and intra-organisational trust is fundamental to how we work – clinical trials, at the end of the day, is a human endeavour.  This presentation will describe the importance of trust in our working relationships, how this can enhance quality and lead to an improved sense of ownership for all staff.  The goal of the presentation is to help us learn to trust a little more.

Learning Objectives

The goal of the presentation is to provide background and information to delegates on the importance of trust in the clinical trial enterprise, from sponsors to service providers to investigator sites.

Quality by Design in Clinical Trials: From Concept to Compliance Under ICH GCP E6(R3)

Summary

With the evolution of ICH GCP guidelines towards a more risk-based and proactive approach to quality, Quality by Design (QbD) has emerged as a cornerstone for ensuring that quality is built into clinical trials from the outset. This presentation explores the practical implementation of QbD principles within the framework of ICH E6(R3), emphasising how early integration of quality risk management can enhance trial efficiency, participant safety, and data integrity.

Through real-world examples and regulatory requirements, it will be examined how to identify critical to quality (CtQ) factors, conduct effective risk assessments, and engage multidisciplinary teams in study planning.

Attendees will gain a clear understanding of the tools, strategies, and cultural shifts required to make QbD a sustainable part of their clinical quality systems.

Whether in clinical operations, quality assurance, or regulatory affairs, this session will equip the audience with actionable guidance for aligning practices with the evolving expectations of global regulators and for making quality a design feature and not an afterthought in clinical development programmes.

Learning Objectives

1. Explain the core principles of Quality by Design (QbD) and how they align with the evolving ICH E6(R3) GCP guidelines.
2. Identify critical to quality (CtQ) factors and understand their role in the proactive planning of clinical trials.
3. Apply risk-based thinking to clinical trial design and execution using practical tools and frameworks.

Navigating Change: Steering Towards a New GCP While Keeping Everyone On-board

Summary

ICH's GCP Renovation has thoroughly overhauled its E8 and E6 clinical trial guidelines, challenging organisations large and small to adapt across all fronts in clinical trials.  We're not done yet but how's it going so far?  This session will consider the breadth and depth of change, from agreeing what was already business as usual to finding where more change is needed.  By thinking about how the challenge has been tackled, can we see how to be well placed when the next big change comes around?

Learning Objectives

• Understand the breadth of change an overhaul of a key regulatory guideline can need-
• Sense-check where your organisation is on the journey
• Anticipate what might still lie ahead for us before we can say we have truly adapted and embraced the change

The QA Echo Chamber: Training Ourselves to Think Differently

Learning Objectives

1. Recognise the behavioural factors that influence audit outcomes, including confidence, listening style, language, and non-verbal cues.
2. Identify the signs of ‘echo chamber thinking’ within QA teams or organisations, particularly where critical thinking or external input is lacking.
3. Explore strategies for cultivating more open, curious, and independent QA professionals within structured environments.

Nothing is Perfect - When Chasing Perfection Goes Wrong

Summary

The session will present real-life case studies, where human imperfections led to critical quality concerns. Through structured root cause analysis, impact assessments, and cross-functional collaboration, these issues were not only resolved but turned into system-wide quality enhancement initiatives.

Key topics include:

• Human-centered root cause analysis beyond “retraining”

• Systemic process flaws hidden behind “human error”

• Differences between expected vs. actual site practices

• How over-documentation and fear of non-compliance erode data integrity

• Practical ways to build process-oriented, not just people-dependent, quality cultures

• Regulatory perspectives and examples from FDA inspection findings and sponsor communications

Learning Objectives

1. Examine how a relentless pursuit of perfection—without recognizing real-world operational challenges—can compromise compliance, subject safety, and data integrity.

2. Highlight the unintended consequences of documentation driven by expectations rather than actual site practices.

3. Provide strategic insights into turning imperfections into opportunities for quality growth.

Practical Guide to Moving a Lab

Summary

Have you ever had to pack up a fully functioning regulatory facility, full of equipment, data, and people then relocate it to another site? This presentation will examine a real life example and delegates will leave with the tools and knowledge to plan, conduct and report their own relocations on any scale.

Learning Objectives

• Planning, Conduct and reporting regulatory operational relocation
• Understanding the Compliance Considerations
• A "how to" guide based on a relocation experience

SaaS, SLAs, and Sanity: Letting Go of Control Without Losing Quality

Summary

In an era of outsourced systems and cloud-based platforms, traditional validation methods don’t always apply or make sense. This session explores the realities of validating SaaS systems in small GxP organisations, where access is limited, control is shared, and the real quality lies in relationships. Drawing on experience validating cloud systems for GLP & GCP use, I’ll share how pragmatic vendor oversight, SLAs, and user-centric testing helped us maintain sanity and compliance in a SaaS world.

Learning Objectives

Explain the compliance challenges unique to SaaS systems in regulated environmentsPropose pragmatic strategies for using SLAs, vendor assurance, and user testing to ensure qualityCompare traditional validation approaches with models better suited for outsourced/cloud-based systems

Human Error or System Failure? Rethinking Root Cause Analysis,

Key Topics:

• The psychology of human error and why it’s rarely the sole cause.
• Limitations of current RCA practices in pharma investigations.
• Practical tools (e.g., 5 Whys+, Swiss Cheese Model) to identify and address system weaknesses.
• Case studies demonstrating how redesigning processes reduced errors more effectively than punitive measures.

Learning Objecvtives

1. Conduct investigations that go beyond blaming individuals.
2. Implement corrective actions that strengthen systems, not just policies.
3. Foster a culture where employees feel safe contributing to problem-solving.

Explore how Intentional Planning and System and Program Design Influence Quality Outcomes

Summary

With the regulatory focus on oversight, proportionality and the holistic framework provided for Data Governance, it’s time to incorporate Quality by Design in Quality management and oversight. This session will discuss how a move from a static ‘one size fits all’ quality model to a holistic and dynamic ‘fit for purpose’ quality oversight process, focused on critical to quality factors and a pragmatic risk-proportional approach can support the effective delivery of drug to patients

Learning Objectives

1. Think differently about the quality approach in line with ICH GCP E6(R3)
2. Identify quality factors based on the study critical to quality factors to support audit planning and conduct quality assurance activities.
3. Summarise the benefits of a proportional quality approach

What are we Doing Here? Overcoming GCP QA's Existential Crisis

Summary

The Quality Assurance role was born in a factory and adopted by clinical research, but the approaches we’ve inherited, with their emphasis on requirements, deviations, and corrective actions, are sometimes an awkward fit for the sprawling, ever-changing clinical research environment. This session will shed some light on why we in GCP QA do what we do and what we might change to better serve our study participants, study teams, and leadership.

Learning Objectives

By the end of the session, attendees will:

• Understand the historical context that led to the current organisation, tasks, structure, and approach for Good Clinical Practice-oriented Quality Assurance
• Be prepared to modify their current approaches to SOP development, auditing, deviation management, CAPA management, and consultation in a way that adds more value to their organisations while adhering to key GCP principles.

Adaptable Approach to Audits: Going off Audit Plan

Summary

In the dynamic landscape of quality assurance audits, meticulous planning is key for successful evaluation. Auditors prepare an audit plan and agenda and get prepared for day one of an audit. During day one: something unexpected emerges. Significant concerns could have arisen or the availability of auditees could have changed. This means that the initial planned approach needs to be adapted.

This presentation will explore the importance of adaptability in navigating such situations and ensuring audit objectives are met effectively. Practical strategies for incorporating changes to the audit scope and timelines, while still achieving the core objectives, will be discussed.

Through real-life case studies where an adaptable approach proved invaluable, the lessons learned will be analysed. Deviating from the initial plan can unlock the most valuable audit insights by allowing focus to shift to areas of heightened risk or concern.Through this presentation participants will gain a deeper understanding of:   

• The inherent need for flexibility in audit execution
• Practical techniques for adjusting audit plans and agendas on the fly
• Methods for effectively communicating and documenting changes
• Strategies for ensuring core audit objectives are met despite unforeseen changes
• The value of embracing unexpected findings as opportunities for deeper insight

Learning Objectives

1. Practical techniques for adjusting audit plans and agendas on the fly

2. Methods for effectively communicating and documenting changes

3. Strategies for ensuring core audit objectives are met despite unforeseen changes

Did you Check the Handbrake Before you Started to Drive Change?

Learning Objectives

• Gain more insight in your own behaviour in managing change
• Understand the potential consequences of your behaviour or a selected change approach on successful implementation 
• Receive a reminder that thinking before doing is (also) essential in successful change management

Round-Table Plenary Sessions

Join these informal, discussion-based sessions designed to encourage open dialogue on pre-defined topics. With a maximum of 10 delegates per table, these sessions offer a unique opportunity to share experiences, ask questions, and explore ideas that may not arise elsewhere in the programme. There’s no hierarchy here, just genuine peer-to-peer exchange. All delegates are encouraged to contribute, connect, and collaborate.

Topics will include:

• Meaningful patient involvement in trial design
• Fostering a Quality Culture
• QA involvement and responsibilities in regulatory intelligence activities and implementation of new regulations
• AI/algorithm Auditing
• Data Governance and Investigator Sites
• and more...

'Zoom, Translate, Repeat': Surviving (and Thriving in) Remote PMDA combined GCP & Stability Data Inspections for Biosimilars.

Summary

As regulatory agencies increasingly adopt (and change) remote inspection models, understanding their expectations - especially in the context of biosimilar development - has become vital. This session will explore key insights from three very unique recent remote PMDA inspections combining clinical studies and product stability data conducted across three different biosimilar clinical development programs in ophthalmology, immunology and osteoporosis indications.

Learning Objectives

1. Summarise the very unconventional modality of the Japanese PMDA inspections of clinical trials in biosimilars;

2. Present examples and complexity of real-live inspection queries trough various inspection stages...full of surprises;

3. Provide guidance for successful implementation & cultural awareness.

Nothing is Perfect - When Chasing Perfection Goes Wrong

Summary

Explore the unintended consequences of perfectionism in pharmaceutical QA. While high standards are essential, the relentless pursuit of flawless systems can lead to inefficiency, fear-driven cultures, and missed opportunities for improvement.

The presentation highlights the gap between actual regulatory expectations and internal overinterpretation, emphasising the need for risk-based thinking and a practical, fit-for-purpose approach to QA. It also addresses the psychological and organisational risks of overcontrol, advocating for a shift toward trust, learning, and balanced quality systems. Ultimately, the talk encourages moving away from perfectionism and toward a mature, sustainable quality culture.

When Everything Feels Critical: How Proportionality Can Save Your Trial

Summary

Are we doing too much or not enough? That is a question many of us face when trying to apply risk-based quality management (RBQM) in real clinical trials. In this session, we will take a practical look at proportionality. What it really means and how to make it work without overcomplicating things or losing sight of what matters most.

We will share real-world experiences of using risk-based decision-making across different phases of clinical development, from protocol design to vendor oversight. We will talk about how to identify what is truly critical to quality (CtQ), how to match your level of control to the level of risk, and what happens when we get that balance wrong on either side.

Delegates will leave with clear, applicable ideas to help them focus their efforts, use resources wisely, and build oversight strategies that are both inspection-ready and fit for purpose. If you are looking for a more agile, effective way to manage quality without falling into the "more is better" trap, this session is for you.

Learning Objectives

After attending this session, delegates will be able to:

1. Apply the principles of proportionality to prioritize quality oversight activities based on risk and critical-to-quality (CtQ) factors.
2. Distinguish between risk mitigation efforts that deliver value and those that introduce unnecessary complexity or burden.
3. Propose proportionate quality strategies for protocol design, vendor oversight, and trial execution that align with both compliance and operational efficiency.

WORKSHOP: QA Efficiencies and Combined Quality Systems

Summary

Regulations are designed for their specific area and the primary focus of these are often not aligned with each other.  When you work in a company that has a QMS with more than one xP or certification how do you make sure you’re hitting all the right points and not duplicating effort?

Join members of the GLP Committee for an interactive workshop where we can learn from each other to understand if we can be more efficient and where we can demonstrate great value for our stakeholders.  

• Are we doing too much?  
• Are we focussed on the right things?  
• Are our risk assessments fit for purpose?

Learning Objectives

Understand the alignment and differences between xPs and ISO standards regularly encountered together.Understand where can alignments can provide efficiencies for organisations and reduce duplication of effort.Streamline QA activities and support operations to maximise efficiency in multi-regulatory Quality Systems.

Curious Conversations: Reclaiming Scientific Thinking to Transform Leadership in Pharma

Summary

In an industry driven by data and detail, leaders often lose sight of one of their most powerful tools: curiosity. This session explores how reactivating a scientific mindset in our conversations - with teams, stakeholders, and vendors - can create deeper trust, drive engagement, and lead to better decisions. Attendees will walk away with practical coaching-inspired communication tools that elevate their leadership impact inside and outside the QA function.

Learning Objectives

• Explain how curiosity-driven communication can improve trust, engagement, and collaboration across teams and stakeholders in pharma and QA environments
• Identify common leadership pitfalls in regulated environments and consider coaching behaviours that foster accountability and performance.
• Apply simple conversation techniques to promote curiosity, reflection, and growth in 1:1s, audits, meetings, and team development settings.

Site-level Quality Issues: from Knowledge Gaps to Malicious Non-compliance

Summary

Quality management at every level of clinical trials is crucial for success.

However, the very foundation of data processing – the source record collection and verification atthe trial site – can become the stage for issues that escalate into critical situations.

In this session, we will explore common challenges faced by personnel at the field level andexamine, through real-life case studies, how these issues can escalate into serious threats to theentire study.

We will also discuss strategies to avoid these pitfalls and how to handle conflicts, including thosewhere one party deliberately tries to provoke them.

Learning Objectives

1. Identify common causes of clinical study failures at the site level.
2. Propose practical preventive measures to ensure adherence to Good Clinical Practice (GCP).
3. Apply conflict resolution strategies to maintain study integrity during challenging situations.

Implementing a Critical to Quality Assessment Methodology in Sponsor Organisations in Support of Regulatory Decision-making

Summary

ICH E8(R1) and E6(R3) recommend a dynamic and risk-based approach to the quality management strategy for a medicinal product development program. Sponsor companies are required to identify factors that are critical to quality (CtQ), to perform ongoing evaluation of the changing risks and quality status in clinical trials and adapt their quality strategy accordingly.

The purpose of the session is to share the latest initiative developed by the Inter-Company Quality Analytics (IMPALA) consortium, the CtQ Assessment Methodology. Delegates will gain an understanding of the core elements of the methodology and how it incorporates the principles of the revised ICH E6 guideline. The value proposition of the CtQ Assessment Report (CAR) for internal and external stakeholders will also be described.

Learning Objectives

• Understand the core elements of the Critical to Quality (CtQ) Assessment Methodology and how it incorporates the principles of the revised ICH E6 guideline.
• Understand how data analytics solutions can (and should) be leveraged to generate clinical quality and compliance evidence.
• Understand the value proposition of the CtQ Assessment Report (CAR) as a 'vehicle' to proactively and transparently report the overall quality and compliance status of the study program to regulatory authorities.

Pragmatic Digital Transformation: Risk-Based Approaches to IT Systems Validation, Data Governance, and AI Implementation

Summary

The pharmaceutical industry faces unprecedented pressure to modernise IT infrastructure while maintaining compliance with evolving regulatory frameworks. This presentation examines how innovative risk-based methodologies can transform audit and validation activities, with practical insights from recent regulatory developments.

We'll explore how major regulatory agencies are evolving their inspection approaches to emphasise risk-based techniques. Health Authorities have implemented risk-categorisation models for regulatory inspections involving IT Systems, focusing on patient impact and data criticality rather than system complexity alone. Similarly, the MHRA’s "GXP Data Integrity Guidance and Definitions," prioritises patient safety impact factors when evaluating computerised systems, allowing for pragmatic allocation of validation resources.

The presentation will examine Risk-Based Quality Management frameworks, demonstrating how risk prioritisation can be adapted for IT system validation planning. We'll provide practical implementation strategies for ICH E6 R3's risk-proportionate methodology, showing how critical thinking rather than excessive documentation satisfies regulatory expectations while accelerating digital transformation initiatives.

Attendees will receive actionable frameworks for audit planning that align with these regulatory approaches, including decision trees for determining appropriate validation scope when implementing AI/ML components in regulated environments. We'll share case studies of successful risk-based validation programs that reduced documentation burden by focusing on patient-impacting functions while maintaining 21 CFR Part 11 compliance.

This session equips quality and IT professionals with pragmatic tools to navigate digital transformation confidently, transforming compliance challenges into opportunities for enhanced data reliability, operational efficiency, and competitive advantage in an increasingly complex regulatory landscape.

Building a Quality Culture: Overcoming Behavioural Barriers in QMS Implementation

Summary

Implementing a Quality Management System (QMS) in a rapidly growing or merged organization can be challenging, especially when employees are mentally unprepared for change and lack understanding of quality assurance (QA). This case study I have prepared explores the hurdles faced during the QMS implementation in a fast-evolving system, where despite modernising electronic platforms, significant mistakes occurred due to the gap in employees' readiness. This session will highlight the importance of training, mentoring, and fostering a strong quality culture to bridge this gap. Delegates will learn how to effectively support teams through behavioural management and change strategies that can drive organisational success. By emphasising transformational leadership and practical examples, this session will showcase how developing a supportive, growth-oriented environment can facilitate smoother transitions and sustained improvement.Learning Objectives:After attending this session, delegates should be able to:    

• Identify key challenges in QMS implementation due to lack of employee understanding.  
• Propose strategies for creating and maintaining a strong quality culture through training and mentoring.
• Explain the impact of mental readiness and behavioural management on organisational change efforts.

This session will provide delegates with actionable insights to apply behavioural strategies and leadership practices that promote growth and quality in any organisation.

Learning Objectives

• Identify key challenges in implementing a QMS in a rapidly growing or merged system with limited employee understanding of QA.

• Propose strategies for building and sustaining a quality culture through effective training, mentoring, and leadership.

• Explain the impact of mental preparedness and behavioural management on the success of organisational change efforts, particularly under resource-limited conditions.

WORKSHOP: Modern World Working Practices and GLP: Pragmatism in Multi-site

Summary

The GLP guidelines were originally developed for work conducted physically onsite at GLP facilities. Today, many GLP activities can be performed remotely, introducing new regulatory challenges especially around multi-site studies. Can a pragmatic approach be used to account for these multi-site challenges? This interactive workshop will explore these challenges that we face in today’s increasingly remote and interconnected working environments.  Attendees will leave understanding the key challenges posed by modern working practices in GLP and gain insight into others shared experiences.

Learning Objectives

Identify the key challenges of modern working practices and the impact on GLP compliance of multi-site studies.Think about the practicalities and challenges of GLP remote working.Consider the perspective of companies performing GLP studies and meeting regulations while providing modern working options for staff.

Risk-Based Training: Proportionality, Prioritisation and How to Avoid Panic Assignments

Summary

Assigning too much training is ineffective, inefficient, and leaves employees feeling very uninspired. Yet when assignment decisions are made, the humans involved are frequently swayed by the perceived risk of ‘saying no’. The result? Too many ‘just-in-case’ assignments, that everyone says ‘someone’ should do something about!

This session will explore a number of risk-proportionate approaches to training, including how they can be presented to inspectors. We will consider the processes for assessing training needs, developing content, evaluating competency and monitoring compliance.

Learning Objectives

After attending this session, delegates will:

• Know the value and importance of taking a risk-proportionate approach to training
• Understand the potential challenges of implementing risk-based training - including technical and human aspects
• Be able to implement 3 practical risk-based training approaches that are straightforward to explain to inspectors

Quality Oversight in Non-Interventional Studies: A Collaboration Project by the RQA and the JSQA

Summary

This session aims to promote a broader understanding of quality assurance practices for NIS around the world. By bringing together QA professionals from different regions, the session will encourage greater international collaborations and exchange of ideas ultimately supporting the continuous improvement of real-world evidence reliability.

Learning Objectives

• Interpret guidelines related to NIS.
• Identify key challenges in provision of quality oversight of NIS.
• Consider the different regional perspectives for NIS.

Creating a Green Future through Compliance and Innovation

Summary

Integrating environmental sustainability into Clinical Research represents a crucial step toward the modernisation of Industry. Sustainability is not merely an add-on but a strategic investment combining economic efficiency, environmental care, and adherence to regulatory requirements. A successful sustainability initiatives can transform operational practices into Clinical Research.

Learning Objectives

• Develop strategic approaches that reduce resource consumption.

• Adopt sustainable sourcing strategies, and minimise the negative environmental footprint.

• Integrating environmental sustainability into the industry.

Consenter and Consentee in Digital Landscape

Summary

As clinical research adapts to decentralised and digital models, informed consent is increasingly managed through electronic platforms. While this enables broader reach and operational efficiency, it risks reducing consent to a transactional process—detached from the ethical and relational foundations that uphold participant autonomy.This session explores how digital tools reshape the consenter-consentee relationship, and what is lost when speed and cost-efficiency override genuine engagement. Participants may rapidly click “agree” without truly understanding/considering/absorbing the risks, expectations, or obligations of joining a trial. Meanwhile, researchers under pressure may lack time, confidence, or support to ensure participants are truly informed. This dynamic threatens not only participant safety but also the defensibility of the study.

We will critically evaluate how digital consent practices affect behavioural dynamics, comprehension, and trust.

Drawing from real-world experiences, the session will also explore training and mentoring strategies to empower staff, embed participant-centred values into practice, and sustain a quality culture where consent is meaningful—even in remote or resource-constrained contexts.

Learning Objectives

1. Critically evaluate how digital platforms reshape the ethical, relational, and behavioural dimensions of informed consent in clinical research.

2. Identify risks associated with digital consent processes, proper consideration, identification—particularly where speed and cost-efficiency pressures limit genuine participant understanding and genuine covenant.

3. Discuss strategies for training, mentoring, and supporting research staff to conduct ethical, participant-centred digital consent while building a reflective and resilient quality culture.

One World, One Quality: Streamlining Sustainable QA Across Borders

Summary

Global clinical trials are expanding rapidly, but patchwork regulatory requirements, cultural nuances, and resource constraints can undermine both quality and sustainability. In this session, we will unpack the key challenges of implementing a unified QA oversight model across multiple regions and showcase opportunities to embed sustainable practices—environmentally, operationally, and financially—into your QA framework. Attendees will leave with practical tools to harmonise processes, reduce redundancy, and achieve lasting improvements in trial quality and cost efficiency.

As sponsors and CROs pursue ever larger, more geographically diverse studies, traditional QA models struggle under the weight of duplicated audits, fragmented oversight, and siloed data.

This session will:

• Map the Challenges – Explore how divergent regulations, varying inspection cultures, and sustainability pressures (travel CO2 footprint, resource utilisation) create complexity and cost overruns.
• Present a Sustainable QA Framework – Introduce QACV’s integrated model that leverages risk based auditing, centralised dashboards, and local partnerships to streamline oversight while minimising environmental and operational waste.
• Interactive Case Studies – discuss real world examples where harmonised QA plans reduced audit days, cut travel costs and improved site compliance. Let’s share pain points and spark peer to peer problem solving.

Let’s simplify global QA, shrink our footprint, and deliver stronger trials—together!

The Hybrid Training Model - best of two worlds

Summary

The session is created for all stakeholders in training processes such as clinical trial managers, operational leadership, QA experts interested in excellence training methodology. During this session we will reveal the methodology and consequences of blending the micro-learning techniques, 360-degree feedback and hybrid training model refined by the mentorship.

Attending this session, the delegates will:

• gain an understanding of effective micro-learning techniques and the power of bite-size digestible lesson delivery, examples included
• get the point of the 360-degree feedback on sustainable training strategy, how work for us
• become aware how role-playing and problem-solving exercise may change the training performance, our statistic talks
• be able to create their own mentoring pathway from knowledge to critical thinking development, diagram and key points of success
• be aware of the advantages of a hybrid training model, how imperfections of online learning could be polished.

This session includes case study discussions to encourage participants to address their own challenges.

Learning Objectives

• Gaining an understanding of effective micro-learning techniques and the power of bite-size digestible lesson delivery, examples included.
• Getting the point of the 360-degree feedback on sustainable training strategy.
• Create own mentoring pathway from knowledge to critical thinking development, diagram and key points of success.

A Quality Role in Operational Aspects of Non-Interventional Studies

Summary

This session will review potential strategies for considering a proportional approach for involving a Quality role in the operational aspects of non-interventional studies.  Possible approaches based on the risk determined for different study types and different stages within the study will be discussed.  The audience are welcome to share their experiences and challenges regarding this topic during the session.

Learning Objectives

• Applying strategy from Clinical Trials to Quality support of non-interventional studies

• Promote risk-based thinking for improving quality in non-interventional studies

• Balance quality needs vs resource implications

Bridging the Gap: Advancing GLP Standards to Propel Africa's Pharmaceutical Innovations

Summary

Africa’s pharmaceutical landscape is evolving, yet challenges in non-clinical drug development persist. This session explores how the African continent can practically strengthen its Good Laboratory Practice ecosystem without striving for unattainable perfection. Delegates will gain real-world insights from DSI/NWU Preclinical Drug Development Platform case study highlighting how pragmatic, quality-focused approaches can drive meaningful progress. Additionally, attendees will walk away with ideas to support sustainable quality systems in resource-constrained environments.

Learning Objectives

• Identify key infrastructural and regulatory challenges affecting GLP implementation in Africa.

• Analyse a real-world case study (PCDDP) as a model for pragmatic GLP development.

• Propose context-sensitive strategies to strengthen quality systems in resource-limited settings

People Before Perfection or the Reality of Quality in Practice

Summary

Behind every SOP, checklist, and validated system stands a person—imperfect, variable, and essential. While quality systems are designed to promote consistency and compliance, they ultimately depend on people to interpret, apply, and uphold them. This session explores the human side of quality management, recognising that human factors can both strengthen and undermine even the most robust systems.

Drawing on real-world examples from daily operations, audits, and inspections, I will examine how cognitive overload, miscommunication, assumptions, and organisational culture often shape outcomes far more than process maps suggest. The session will also explore how fostering psychological safety, delivering meaningful training, and designing systems with people in mind can reduce risk and support sustainable compliance.

Recognising and supporting the “imperfect human” isn’t a weakness in quality—it’s a necessity, and something we must actively consider when designing, implementing, and maintaining our quality management systems.

Learning Objectives

1. Recognise common human factors that influence quality system performance

2. Apply pragmatic strategies to design and implement quality processes

3. Evaluate opportunities to strengthen quality management systems

Pioneering Quality Assurance Through Artificial Intelligence: Balancing Innovation, Speed, and Compliance Across All Levels of QA

Summary

The pharmaceutical industry faces unprecedented pressure to modernise IT infrastructure while maintaining compliance with evolving regulatory frameworks. This presentation examines how innovative risk-based methodologies can transform audit and validation activities, with practical insights from recent regulatory developments. We'll explore how major regulatory agencies are evolving their inspection approaches to emphasise risk-based techniques. Health Authorities have implemented risk-categorisation models for regulatory inspections involving IT Systems, focusing on patient impact and data criticality rather than system complexity alone. Similarly, the MHRA’s "GXP Data Integrity Guidance and Definitions," prioritises patient safety impact factors when evaluating computerised systems, allowing for pragmatic allocation of validation resources.

The presentation will examine Risk-Based Quality Management frameworks, demonstrating how risk prioritisation can be adapted for IT system validation planning. We'll provide practical implementation strategies for ICH E6 R3's risk-proportionate methodology, showing how critical thinking rather than excessive documentation satisfies regulatory expectations while accelerating digital transformation initiatives. Attendees will receive actionable frameworks for audit planning that align with these regulatory approaches, including decision trees for determining appropriate validation scope when implementing AI/ML components in regulated environments.

We'll share case studies of successful risk-based validation programs that reduced documentation burden by focusing on patient-impacting functions while maintaining 21 CFR Part 11 compliance. This session equips quality and IT professionals with pragmatic tools to navigate digital transformation confidently, transforming compliance challenges into opportunities for enhanced data reliability, operational efficiency, and competitive advantage in an increasingly complex regulatory landscape.

Do We Really Need to Validate an eSignature tool Used by Half the Industry?

Summary

Spoiler: Yes, you do have to validate your e-signature tool, even if it’s widely used throughout the industry. While many in the industry are embracing innovative technologies such as AI, there are still many companies struggling to understand and apply basic principles of data integrity and computer systems validation. Particularly in smaller companies which may lack dedicated expertise, lack of or insufficient validation remains a common audit finding. There are many suppliers who market their systems as ‘fully validated’ and ’21 CFR part 11 compliant,’ without explaining to their customers that no system can be considered part 11 compliant without adequate user access controls, training, and procedures – and it is the customer’s responsibility to ensure those in place. Even if a system is used by other companies, how do you know it’s the right system for your company? How do you know you’re using it correctly, in a way that will ensure the needed data integrity?

This session will offer concrete advice on how to identify system-related risks, how to convince management why validation is necessary, and where to start when validating systems or auditing electronic records.

Learning Objectives

• Understand the link between validation, fitness for purpose, and data integrity
• Explain (e.g., to management or budget holders) why validation is needed even for low-risk systems
• Apply flexible approaches to system validation

•  

WORKSHOP: Pragmatic Data Integrity: Navigating Challenges in Veterinary Studies

Summary

Data integrity requirements aren't new, but veterinary studies present unique challenges that demand pragmatic approaches rather than rigid perfection. This interactive 90-minute workshop—collaboratively hosted by the Animal & Veterinary Products, GLP, and IT committees—will explore practical solutions that work in real-world veterinary research environments.

Learning Objectives

• Compare the benefits and limitations of paper versus electronic data capture (EDC) systems in veterinary settings

• Develop pragmatic approaches to data recording and corrections that maintain compliance while acknowledging field realities

• Create practical strategies for managing diverse source data from veterinary practices, farm records, and laboratory results
• Build a toolkit of proportionate responses to common data integrity challenges

From Protocol to Practice: Integrating ESG Metrics into GCP Audits for Sustainable Clinical Trials

Summary

The pharmaceutical industry’s commitment to the UN Sustainable Development Goals (SDGs) is reshaping how clinical trials are designed, conducted, and monitored. Further reinforced by WHO’s Global Clinical Trial Forum, 2022. Building upon my earlier advocacy for sustainable clinical trials through QA practices, this presentation introduces a new and pragmatic methodology to embed Environmental, Social, and Governance (ESG) metrics directly into GCP audits.

Traditionally, GCP audits have focused primarily on subject protection, data integrity, and regulatory compliance. However, to support the broader sustainability agenda, QA functions may now adapt audit frameworks to evaluate ESG  factors within clinical trial operations — without compromising patient safety, regulatory compliance, or data quality.

This presentation proposes a structured methodology for integrating ESG metrics into clinical QA audits, moving from a compliance-only view to a sustainability-conscious, risk-based oversight model. This presentation will include ESG aligned audit planning, ESG worksheet and evaluation criteria, scoring system, integration of ESG in continuous improvement.

Learning Objectives

• Awareness about sustainable QA practices
• Use case of integrating ESG elements in GCP audits

The Beauty of Human Imperfection and How it Shapes Quality Systems

Summary

A Quality System is not about striving for perfection, but rather it is the opposite: Quality systems are about recognising that we as humans are beautifully imperfect, but we can develop ways to document and learn from such imperfections.  This session will explore the speaker’s Quality experiences in three different industries and how quality systems can mitigate human frailties to provide proper care and quality products.

Learning Objectives

• Understand the impact of human frailties and imperfections and how to best design Quality Systems around them.

• Identify key challenges in designing Quality Systems in challenging environments by embracing human imperfections instead of fighting against them.

• Appreciate the value of deviations and CAPA’s as a tool for improvement and not a negative task or experience.

Quality in Focus: Going Beyond Metrics to What Truly Matters

Summary

In this session, we explore a critical evolution in quality thinking—shifting beyond traditional metrics to focus on what truly reflects system effectiveness and organisational integrity. While commonly used indicators like audit findings, deviation counts, and CAPA timelines serve an important role, they often fail to capture deeper insights into quality culture, human behavior, and process robustness. This session challenges delegates to rethink their approach to measurement and embrace a more holistic, meaningful framework.

Learning Objectives

• Evaluate the limitations of traditional quality metrics and identify gaps between measured performance and actual system effectiveness.
• Design meaningful, purpose-driven quality indicators that incorporate both quantitative and qualitative insights, including human factors and cultural dimensions.
• Apply practical strategies to shift from compliance-focused measurement to a holistic approach that supports continuous improvement, risk mitigation, and organisational learning.

IQ, OQ, PQ - No More? Driving Value - Adding Records in CSV

Summary

The days of blindly following IQ, OQ, PQ for computerised system validation (CSV) are numbered. This session explores how critical thinking, risk-based assurance, and digital validation tools can help you generate meaningful, inspection-ready documentation – without the unnecessary baggage! We’ll challenge outdated assumptions and highlight practical ways to streamline your validation activities while staying aligned with current regulatory expectations. Whether you’re dealing with SaaS, off-the-shelf platforms, or bespoke systems, you’ll learn how to focus effort where it counts rather than filling out templates for the sake of it. Modern CSV starts here.

Learning Objectives

• Understand why IQ, OQ, PQ may not be the best option for most computerised systems, and explore alternative strategies to reduce unnecessary documentation while maintaining control and data integrity.
• Gain confidence in challenging legacy practices and driving cultural change towards value-adding CSV.
• Discover how digital validation tools can streamline CSV and improve traceability without increasing burden.

Preparing for the Unexpected: Balancing US Cloud Dependencies with Practical Backup and Mirror Strategies

Summary

This case study explores how a European healthcare and research organisation proactively addressed its dependency on US-based cloud infrastructure by implementing a pragmatic and risk-based continuity strategy. While their existing setup was GxP-compliant and operationally robust, emerging EU regulations (e.g. NIS2, Cybersecurity Acts) and geopolitical uncertainties raised concerns around data sovereignty and long-term resilience.

The organisation responded by designing a hybrid cloud architecture that preserved the efficiency of their primary US-based cloud while incrementally integrating EU-hosted fallback environments for sensitive workloads. Key measures included the implementation of mirror environments (shadow infrastructure) for critical databases and risk-based data inventory workshops to prioritise systems for backup and replication. By scaling mirror environments only when needed, they balanced operational readiness with cost efficiency.

They also embraced open-source frameworks to reduce vendor lock-in and maintain long-term flexibility.

This forward-thinking approach reflected the RQA 2025 theme “Quality that Works: Pragmatism over Perfection”, as they avoided full-scale overhauls and instead focused on proportional, sustainable improvements.

The case illustrates how thoughtful planning, modular design, and regulatory alignment can strengthen data integrity and business continuity—without compromising agility or overspending—enabling organisations to prepare effectively for unexpected disruptions in an evolving global and compliance landscape.

Learning Objectives

• Understand how to implement pragmatic cloud resiliency strategies that align with evolving EU regulatory requirements.
• Participants will learn how to assess and address data sovereignty risks using hybrid cloud architectures, mirror environments, and risk-based prioritisation—supporting compliance with frameworks such as NIS2 and the EU Cybersecurity Acts.
• Evaluate risk-based methodologies for backup, mirroring, and infrastructure redundancy
• Attendees will explore how to conduct data inventory workshops and apply proportional fallback strategies, focusing resources on high-risk systems without overinvesting in low-priority areas—enabling balanced continuity planning.
• Learn how to integrate cost-effective, scalable mitigation tools into GxP-regulated cloud environments.
• The session will introduce practical approaches such as open-source frameworks, shadow infrastructure, and incremental EU-hosting deployment, helping organisations maintain GxP compliance, business continuity, and cost control in an uncertain geopolitical landscape.

Key Considerations for the PV Audit Report

Summary

This session will break down the various aspects of audit reporting including a practical approach to determine whether to make (or leave out) a finding, presentation of findings in closing slides vs audit report, categorisation/grading, proposed actions, responses to audit findings, and review of rejected findings. Attendees will leave with pragmatic ways to assess and structure the audit findings & report in their audit reports based on their unique organisational setup.

Learning Objectives

• Risk-based and practical approach to determine whether to make (or leave out) a finding
• Presentation of findings in closing slides vs audit report
• Harmonized categorisation/grading of findings
• Use of Proposed Actions in Audit Reports Adequate responses to audit findings
• Reviewing rejected Findings

The Human Element in QbD: Designing Systems and Programs for Optimal Operator Performance and Reduced Human Error

Summary

While technology plays a significant role, human factors are crucial in pharmaceutical and biotech manufacturing. This presentation explores how QbD principles can be applied to the design of user interfaces, training programmes, and workflows to minimise human error and enhance operator performance, ultimately contributing to consistent product quality. Consider incorporating principles of human-centered design and usability engineering.

This presentation will explore how the proactive and intentional principles of Quality by Design (QbD) can be strategically applied to the design of systems, programs, and workflows to optimise operator performance and significantly reduce the potential for human error.

Practical strategies and real-world examples will illustrate how incorporating human factors into the design process can lead to significant improvements in operational efficiency, a reduction in deviations and errors, and ultimately more consistent product quality. Attendees will gain valuable insights into how to integrate HCD and usability engineering principles within their QbD initiatives to create systems and programmes that are not only robust from a technical perspective but also optimised for human interaction.

Learning Objectives

1. Identify and apply key principles of human-centered design (HCD) and usability engineering within the Quality by Design (QbD) framework to optimise the design of pharmaceutical and biotechnology systems and programmes.
2. Describe strategies for designing effective training programmes, aligned with QbD principles, that go beyond basic procedures to enhance operator competence, reduce human error, and improve adherence to quality standards.
3. Evaluate and implement practical approaches for designing workflows and user interfaces that minimise the potential for human error in pharmaceutical and biotechnology manufacturing environments.

Pragmatic Vendor Management: Optimising Proportionality, Risk-Based Decision-Making, and Investigator Oversight

Summary

Risk-based thinking is reshaping vendor management, with ICH-GCP E6(R3) placing renewed focus on proportionality and investigator oversight. This session introduces a comprehensive methodology for vendor qualification and ongoing management, highlighting proportionality in decision-making. Attendees will discover practical strategies to optimise resource allocation, implement continuous monitoring for vendor reliability and provide investigators with robust documentation to support their oversight responsibilities.

Learning Objectives

• Develop and apply KPIs/metrics to monitor vendor compliance and refine audit strategies.

• Provide investigators with robust documentation to support their oversight and approval of vendors.

• Apply practical tools, such as tailored questionnaires and risk assessment frameworks, to ensure efficient and compliant vendor management.

Panel on the impact of ICH E6R3 and ICH E8 on the Trial Master File

Summary

The long awaited third revision of ICH E6 Good Clinical Practice is finally upon us, and there are some significant developments when it comes to trial master file and essential records. It is evident in the updated guidance that the regulators are looking to align the guidance with more modern, risk-based approaches to records management that we now typically see within clinical trials.  

In this session we will first present some of the primary changes and impacts with regards to essential records, risk proportionality, data governance, quality management and computerised systems among other aspects. We will also discuss some of the initiatives that are being taken by the CDISC TMF Reference Model to align with E6 R3.

Following the presentation, an interactive panel discussion will be led by the Institute for Clinical Research with input from CDISC on the impacts on ICH E6 R3 on TMF as well as some of the opportunities for a more data driven, focused and proportionate approach to compiling the trial master file. The panel will also discuss appendix C and the criteria contained within for identifying essential records, and how these criteria will result in more focused and relevant TMFs moving forward.

Learning Objective

Impact of the regulations on TMF Upcoming changes to the TMF Reference Model Digital future of TMF

WORKSHOP: Fight the Fear: Laboratory Audits and Fit-for-purpose Method Validations

Summary

Laboratory audits can feel daunting - especially for QA professionals whose primary focus lies outside the lab. Whether it’s complex method validations or navigating conflicting interpretations of regulatory guidance across stakeholder groups, it’s easy to feel out of depth. Fight the Fear is an interactive and supportive workshop designed to demystify laboratory oversight and method validation through a pragmatic, risk-based lens. By working through real-life scenarios and peer insights, delegates will gain confidence, clarity, and adaptable principles they can apply in any research environment - regulated or not.

Learning Objectives

After attending this session, delegates will be able to:Interpret relevant guidelines to identify the quality factors most critical to laboratory method validation, Evaluate laboratory practices in clinical, academic, and regulated settings using pragmatic, risk-based thinking, and Develop their own context-sensitive principles to support defensible decisions in laboratory audits and oversight activities.

Quality by Design: Building Excellence Through Intentional Planning and Pragmatic Auditing

Summary

In a world where complexity is rising and resources are limited, perfection is no longer the benchmark—purposeful, pragmatic quality is. This session explores how Quality by Design (QbD) can be used to create systems, audits, and programmes that are intentionally built to work in the real world.

Learning Objectives

Define the core principles of Quality by Design and explain how they apply to systems and programme development.

Beyond the Checkbox: Redefining Vendor Oversight as a Strategic Advantage

Summary

Too often, vendor oversight is treated as an administrative task or a regulatory checkbox - yet failure to get it right results in far more than non-compliance. It risks data integrity, patient safety, operational delays, and financial loss.

This session challenges the conventional view of vendor assessment as a burdensome obligation and instead presents it as an essential strategic function. Delegates will explore how risk-proportionate oversight can not only mitigate threats but also unlock value, protect investment, and enable effective collaboration across the product lifecycle.

Drawing on real-world examples from preclinical and clinical laboratory settings, the session will provide practical tools and frameworks to support more confident, outcome-driven oversight. While the focus is on laboratory-based service providers, the session will offer valuable insights for anyone involved in vendor oversight—particularly those seeking to enhance collaboration, quality, and efficiency in outsourced functions.

Learning Objectives

• Reframe vendor oversight as a contributor to quality outcomes, operational resilience, and business success—not merely as a compliance requirement
• Recognise the risks of under- or over-engineered vendor processes and adopt a proportionate, pragmatic approach
• Gain confidence in applying risk-based tools to make oversight more meaningful, efficient, and value-driven.

Round-Table Plenary Sessions

Join these informal, discussion-based sessions designed to encourage open dialogue on pre-defined topics. With a maximum of 10 delegates per table, these sessions offer a unique opportunity to share experiences, ask questions, and explore ideas that may not arise elsewhere in the programme. There’s no hierarchy here—just genuine peer-to-peer exchange. All delegates are encouraged to contribute, connect, and collaborate

Proportional Response to Inspection Hot Topics with the GLP Committee and MHRA

Join members of the GLP Committee and a representative from the MHRA GLP inspection team as we present scenarios covering GLP inspection hot topics. Each scenario will be presented for interactive discussion on proposed response, outcomes and actions to be taken with the GLP committee and MHRA inspector providing their feedback based on their real-world experience. The focus will be on identifying pragmatic, risk-proportional solutions and opportunities to re-think responses to recurring, long-standing challenges. 

Scenarios will cover (exact scenarios to be confirmed):

• Effective & Proportional CAPA
• Electronic Archiving, 
• Test Item Characterisation and Stability, 
• Equipment Qualification,

QbD: Design to Execution at Warp Speed using AI

Summary

In today’s clinical research environment defined by complexity, cost pressure, and compressed timelines, accelerating development without compromising quality is non-negotiable. This session presents the evolution of Quality by Design (QbD) that is transforming the clinical trial paradigm through acceleration powered by artificial intelligence and digital twin technologies.

Participants will learn how AI enhances QbD across the trial lifecycle - fsrom design to execution - by enabling smarter decisions, earlier risk mitigation, and faster, more adaptive delivery. They will discover how AI-driven approaches are reshaping protocol design, site and patient selection, and risk-based monitoring; delivering unprecedented efficiency and precision. Case studies will illustrate how digital twins simulate and optimise trial execution in silico, reducing operational and quality risk and compressing development cycles.

Beyond technology, this session will also outline practical steps for implementation, including data integration, change management, and regulatory engagement. By the end of the session, participants will have a clear understanding of the power of integrating AI and digital twins into QbD strategies to unlock operational agility, future-proof compliance, and deliver clinical programs with confidence and speed.

KEYNOTE: Beyond the Perfect Pill: How Pragmatic Quality Will Save More Lives

This keynote will challenge conventional thinking about quality in life sciences, exploring how a pragmatic approach—one that prioritises patient outcomes over procedural perfection—is already transforming the industry. We'll explore how pragmatic quality frameworks are accelerating time-to-market, reducing costs, and most importantly, getting life-saving treatments to patients faster. We'll also look ahead to 2030 and beyond, where continuous manufacturing, digital twins, and predictive quality systems will make today's batch-and-release paradigms seem as outdated as bloodletting. The future belongs to organisations brave enough to ask not "Is it perfect?" but "Will it help?" Join us as we explore how embracing imperfection might just be the key to saving more lives.