How I Learned to Stop Worrying and Love the Vendor Document

Using real-world archetypes ranging from "dream vendors" with full GAMP 5 supplier packs to "ghost vendors" who've never heard the word validation, it provides practical frameworks for assessing what vendor documentation is acceptable, what requires supplemental testing, and where the common inspection pitfalls lie. 

The core message is simple: critical thinking and risk-proportionate effort deliver better patient safety outcomes than 3,000 pages of screenshots ever did.

Auditing PV (sub)contractors: Ensuring QPPV Oversight in Complex Multi-layer Vendor Chains

It outlines practical audit techniques to verify vendor visibility, contractual clarity, and communication pathways to ensure essential PV information reaches the QPPV. With increasing regulatory expectations under Implementing Regulation (EU) 2025/1466, the session provides pragmatic guidance for auditing all subcontracting layers to prevent oversight gaps.

Accidental GCP: When Exploratory Became Evidence

The session follows the lab’s rapid shift from informal scientific practice to a GCP aligned operating model, supported by targeted quality expertise and pragmatic, risk based controls. Delegates will gain practical insight into identifying quality gaps, stabilising high risk processes under operational pressure, and transforming ad hoc exploratory work into defensible, decision ready clinical evidence through proportionate measures that protect both data integrity and patient safety.

The case study offers a grounded view of how exploratory work can unexpectedly cross into the clinical domain - and how organisations can respond with speed, structure, and confidence.

Beyond Bolt-On: Embedding Data Privacy into Clinical Trial Operations

This interactive workshop will get you thinking about clinical and privacy processes  as synchronous activities, achieving better controls for participants, more efficient processes and lowering the risk of data breaches.

Proportional Response to GLP Inspection Hot Topics

For each deficiency, we will ask the delegates to discuss how they would respond and what actions they would take. Focus should be on pragmatic, risk-proportional solutions. 

The Committee will then present how we would respond and what actions we would suggest are taken based on our experience.

We will then invite the regulator on the panel to feedback on our proposed response and offer any advice or guidance.

When "The Vendor Said It's Fine", It Isn't Fine at All: Lessons from a Cloud System Implementation

What is the role of the customer / user in validation? How can the customer ensure the system fits into their way or working, or modify their way of working to make the best use of the system? This presentation uses a recent eTMF implementation as a real-world case study to highlight the challenges encountered when working with a cloud service provider and leveraging their validation documentation, and the pragmatic solutions necessary to ensure GxP compliance, from both a technical and procedural perspective, ultimately to ensure data integrity. Whilst the case study centres on an eTMF platform, the risks and solutions are applicable to all cloud-based systems, across any GxP.

Mind the Gap Between Readiness and Capability: What Should Be Asked in PV System Audits

While documentation, SOPs and polished presentations can reflect good preparation, they do not always show how a system performs under real conditions or how well a vendor manages changes, deviations, validation, data integrity or resource parameters. Usings insights from the PV service provider side, this session highlights which audit questions help MAHs move beyong surface-lvel readiness to assess real capability and operational maturity. 

Delegates will gain practical insight into how to strengthen MAH-vendor audit effectiveness by asking questions that reveal quality in practice, not just on paper.

A Journey from University Spin-Out to Interventional Studies: The QA Perspective

It will share practical experiences of developing a proportionate Quality Management System (QMS), embedding Good Clinical Practice (GCP) principles, and working collaboratively with research teams unfamiliar with clinical trial regulations. Delegates will gain practical insights and lessons learned on how education, cross-functional collaboration, and access to external expertise can support small, innovative organisations in building effective quality frameworks while enabling the safe and compliant delivery of early clinical research.

Designing for Behaviour, not Attendance: Rethinking What Training is For

Using a workshop format, participants will design tasks, explore scenarios, and test their designs across different contexts. This will allow participants to develop practical, justifiable training interventions that address real behavioural risks within research settings. By drawing on sector experience from presenters and participants and linking into forthcoming Research Practice Group guidance, the session will equip delegates with practical, actionable insights into what genuinely drives reliable behaviour and what commonly fails.

Taking the Leap: Quality Assurance in the Transition to NAMs

How can the gap between traditional testing paradigms and emerging human-relevant approaches be bridged? What assurances are needed to build scientific confidence in NAMs, and what should today’s QA professionals understand about their development, validation, and application to support their use in a regulatory context?

New Approach Methodologies are best understood within their broader historical and scientific context. Over the past several decades, these methods have evolved from research and screening tools into increasingly important components of modern safety assessment and regulatory decision-making. Understanding their development, current applications, and growing global acceptance provides valuable perspective on the opportunities and challenges associated with their broader implementation.

Central to this evolution is the quality framework that supports method validation, scientific credibility, and regulatory acceptance. Key elements of successful validation programs, such as establishing fitness for purpose, understanding human biological relevance, robust technical characterisation, maintaining data integrity and transparency, and incorporating an independent review, play a critical role in establishing confidence in these approaches. Quality assurance professionals bring essential expertise in study conduct, risk assessment, data evaluation, and quality oversight, making them important collaborators to support validation work towards the advancement of NAMs.

As the scientific landscape continues to evolve, the fundamental principles of quality assurance remain indispensable. A clear understanding of NAMs, their validation pathways, and their role within regulatory frameworks will help QA professionals bridge the gap between rapidly advancing science and regulatory confidence, ensuring that emerging testing approaches are supported by robust quality systems and reliable, decision-ready data.

The Devil in the Deviation: Shifting from Counting Events to Capturing the Story

This presentation calls for a shift toward treating deviations as structed, enduring narratives that provide clear context, scientific reasoning and transparent documentation to support stronger investigations and more reliable risk and impact assessments.

Mind the Flow: Creating Practical Data Flow Maps for Clinical Trial Systems

This workshop will show delegates how to build a practical data flow map that makes visible where data originate, how they move, where they are transformed, which metadata matter, and where key control points sit, using ICH E6(R3) principles and the EMA expectation for a documented data-flow diagram as the regulatory anchor. Delegates will leave with a repeatable method they can use to assess data integrity risk, validation scope, vendor oversight and inspection readiness.

Do Not Pass Go: CSA, AI/ML & the Art of Auditing What You Can't See

Delegates will leave with a practical understanding of risk-proportionate validation under CSA, a clear picture of where AI/ML is already embedded in their GxP landscape, and a ready-to-use set of audit questions for evaluating AI-enabled systems and their vendors.

Can We Really Do It All? Minding the Gap Between Regulatory Requirements

This 45-minute session will explore the key differences and overlaps among GCP, GLP, and GMP regulations, highlighting the challenges organisations encounter when supporting activities that span multiple regulatory domains. Attendees will gain practical insights into identifying regulatory gaps, harmonising quality systems, leveraging risk-based approaches, and building sustainable compliance programs. The session will also examine opportunities to strengthen inspection readiness and foster cross-functional collaboration while maintaining compliance across the product lifecycle.

How Data Privacy can make the Difference on your QA Journey

This session will show you how the principles of privacy by design and quality by design go hand in hand throughout the data lifecycle to build strong data governance.

It will also illustrate how a structured approach to data protection can serve as concrete leverage for Quality Assurance and, conversely, how failing to uphold these principles can directly impact GxP requirements and expose organisations to significant operational and compliance risks

Can You Trust the Output? The New QA Playbook for Hallucinations, Source Traceability, and AI-Credible Evidence in Clinical Trials

While the industry has focused heavily on speed, automation, and productivity, far less attention has been given to how QA teams will evaluate hallucinations, validate traceability to source, govern model use in GxP-relevant processes, and defend AI-supported decisions under inspection.

This session will explore how the role of QA is evolving from retrospective reviewer to proactive governor of AI-enabled clinical trial processes. It will outline the emerging risks associated with GenAI and agentic systems in clinical development, including fabricated or weakly supported outputs, loss of lineage to source data, over-reliance on AI-generated summaries, and the growing challenge of demonstrating what evidence was used, by whom, and under what controls.

The presentation will introduce a practical QA playbook for AI oversight in clinical trials, focused on source traceability, human review checkpoints, risk-based control design, and inspection-ready documentation. Attendees will gain a clear framework for assessing where AI can safely support quality and operations, where additional controls are required, and how QA can lead the industry in building trust, transparency, and governance into the next generation of trial delivery.

Bridging Gaps in International and Cross-Functional Teams

What does the word “site” mean to you? Your answer may depend on the GxP area in which you work. A lot of frustration and inefficiency can come from team members not speaking the same language, whether literally – e.g., in international teams – or figuratively – e.g., across functions or across GxP areas. 
Traditionally, “culture” referred to the moral and behavioral norms within a country or region, but we also talk of “company culture” and “quality culture.” Increasing understanding of the people we work with, how they think and how they communicate, can help to bridge communication gaps within teams and facilitate collaboration. And with the ongoing rise of the use of AI, cultural awareness and improved communication may be among those skills that will help to keep us human and competitive in the labor market.

Strengthening Quality Oversight of Non Interventional Studies (NIS): A Practical, Hands On Framework for Real World Evidence

This interactive workshop will provide participants with a practical, experience based framework for strengthening Quality oversight of NIS, drawing on principles from The NIS Handbook: Quality Oversight of Non Interventional Studies (2026). Through case studies, group exercises, and facilitated discussion, attendees will explore common pitfalls in NIS (e.g., unclear classification, inconsistent safety reporting, documentation gaps, data provenance issues) and learn how to apply a risk proportionate approach grounded in ICH E8(R1), ICH M14, GVP, GPSP, and GPP. Designed for QA professionals, PV specialists, Investigator-supporting teams and cross functional partners, this session bridges the gap between regulatory expectation and operational practice, empowering teams to deliver credible, ethical, and inspection ready real world evidence.

The Data Burden Problem: How Overly-Complex Trials Create Both Ethical and Quality Risks

Excessive data collection heightens participant burden, reduces accessibility for under represented groups, and limits equitable participation. Simultaneously, overly complex protocols increase the risk of protocol deviations, missing data, operational inefficiencies, and workload pressures at research sites.
This presentation examines the often-overlooked connection between ethical considerations and quality management in clinical research. Drawing on Emma’s recent Trials Journal publication, “The undue burdens of clinical trial participation: implications for equity, diversity, and inclusion,” it illustrates how ethical concerns such as participant burden, fairness, and proportionality are tightly linked to core quality risks in trial design and conduct.

Bridging Human Expertise and AI for Inspection Readiness

Using practical examples and real-world use cases, we will examine how AI can support activities such as document summarisation, storyboarding, trend analysis, audit report consistency and CAPA management, while highlighting the areas where oversight, context and regulatory judgement remain essential.

Closing the Gaps: Modernising GLP for a Changing Global Landscape

The OECD GLP Industry Discussion Group (IDG) was appointed by members of the OECD GLP Working Party (WP) to bridge the gaps between industry and the GLP Compliance Monitoring Authorities. At the request of the OECD GLP WP, the IDG sent out a survey in Q1 2026 to ask Industry where there are gaps in the OECD GLP Consensus and Advisory documents.  During this session, members of the OECD GLP IDG will share a summary of the outcome of the survey and chat with representatives from Compliance Monitoring Authorities about some of the gaps that have arisen in the OECD GLP Compliance Series as a result of new knowledge, new technology and global developments. There will also be a chance for audience participation with questions and polls. 

Panel includes:

• Chrissy Cohran (USA FDA Compliance Monitoring)
• Kathryn Suttling (USA FDA Compliance Monitoring)
• Holger Uhde (Swiss Industry Representative)
• Nina Häuselmann (German Industry Representative)
• Catherine Liang (French Industry Representative )
• Christine Mitchell (Dutch Industry Representative)

Ask the Experts - Compliance Questions in a Changing Regulatory Landscape

With a focus on ICH E6(R3) and emerging AI regulations, the panel will explore where gaps exist between guidance, interpretation and practice across regions. Attendees are invited to ask any questions - from auditing to oversight to innovation and inspection readiness - making this an interactive forum for candid discussion, shared perspectives and practical insight on how to navigate compliance challenges globally.

The Hidden Gaps in GxP Audits: Why Findings Repeat and How to Break the Cycle

This session explores why repeat findings persist and what this reveals about the true effectiveness of audit programmes. It will examine structural and behavioural gaps, including superficial root cause analysis, CAPA focused on symptom resolution, limited cross-functional learning, and audit scopes that fail to detect systemic issues.

Drawing on real-world audit trends and inspection observations, the session will highlight patterns that create a cycle of “finding–closure–recurrence.” It will also introduce practical metrics to assess audit effectiveness beyond activity levels, including repeat observation rates, CAPA recurrence indicators, time-to-effective-closure, and evidence of sustained process improvement.

The session will emphasise how organisational culture, risk prioritisation, and audit design influence whether audits drive meaningful change or simply confirm compliance.

Key Areas Covered:

• Root cause analysis gaps and why CAPAs fail to prevent recurrence
• Patterns and drivers behind repeat audit and inspection findings
• Metrics for measuring audit effectiveness (e.g., recurrence rates, closure timelines, CAPA effectiveness)
• The role of audit scope and design in identifying systemic issues
• Organisational and cultural factors influencing sustainable compliance.

Mind the Gap Between ICH E6(R3) and Reality: A Practical Training Journey

We begin with an overview of R3 requirements focusing on competence, role based training, and accountability, highlighting what is explicitly required vs. what is left to sponsors, CROs, and sites to define.

• The session examines gaps in training support provided by ICH, including the absence of prescriptive guidance, standard curricula, or role specific examples—often leading to inconsistent or overly generic training approaches. Using real world examples, the training illustrates where these gaps commonly arise and how they can impact compliance, inspection outcomes, and study quality.
• A key focus is the application of a measured approach to training, aligned with the principles of E6(R3). Attendees will learn how to assess training needs based on critical activities, data and process risks, system complexity, and individual roles, rather than relying solely on one time or blanket training.
• Finally, the session addresses what meaningful recurring training might look like under E6(R3—covering triggers for retraining (e.g. process changes, deviations, inspection findings), methods to reinforce learning over time.

Mind the Digital Gap: Evolving Validation, Auditing and Evidence

This session considers what effective assurance looks like as validation deliverables, audit methods and evidence generation become increasingly digital, automated and interconnected. Through three complementary perspectives, the speakers will examine how validation documentation is moving towards proportionate, risk-based assurance; how auditors’ questions, skills and mindset must adapt to modern digital environments; and how digital tools can support evidence generation without compromising data integrity, transparency, traceability or auditability.

The final 30 minutes will bring the three themes together in an interactive Q&A. Prepared seed questions and delegate experiences will be used to explore practical challenges, emerging risks and workable approaches that QA professionals can take back to their organisations.

One Lab Auditor to Audit Them All: Differences Between Lab Audits in GLP, GCLP and Central Labs

While in some cases the technical methodologies used in each area can cross over, the overall regulatory scope can differ. 

This session will cover the differences in regulatory scope for auditing laboratory work performed under GLP, GCLP and ISO15189 and the where the overlap between the regulations occurs so that one auditor can perform audits in labs across these regulations.

Annex 2 - big picture view

Annex 2 will be have been out around 6 months by the conference and will be about to be implemented in the EU. We will set the back ground to Annex 2, specifically whilst embedding it in the entire R3. We will get everyone to the same point with a few slides of background, then move onto the intricacies of Annex 2 and how they link back to the Principles.
 

Managing Outsourced Activities - How to Build Partnerships and Avoid Misunderstandings

This session will share knowledge on how to implement quality system processes to select, manage and evaluate service providers throughout the course of a clinical trial. Attendees will learn what a good service provider management system looks like in practice, to help build partnerships and avoid misunderstandings that could have a negative impact on trial participants, data quality, and GCP compliance.

Internal Audits: from Compliance Obligation to Strategic Quality Tool

At our CRO we performed a gap analysis to optimise the audit process, focusing on the audit preparation part to significantly increase the value generated by internal audits. 
This presentation will focus on the identified process improvements and demonstrate how a structured, risk based, and collaborative approach to audit preparation can close this gap. We will share our continuous ongoing journey of redesigning the internal audit process.

Attendees will learn how to implement a "pre-audit alignment strategy” that defines depth and focus early on. By optimising the intake process, we demonstrate how QA can move beyond box-ticking to deliver targeted, high-value insights that truly align with business needs.

Mind the Gap Between Automation and Compliance: Using AI for Issue Management and Root Cause Analysis in GxP Environments - Workshop

Delegates will apply readily available AI tools to develop a CAPA based on a common scenario and, as a group, compare outcomes to assess accuracy, consistency and suitability for regulated use. Attendees will leave with a practical understanding of both the opportunities and limitations of AI in inspection-ready quality decision-making.

Bridging the Oversight Gap

We’ve all heard terms such as quality culture and embedding quality into all aspects of trial management, but what do we as quality professionals see in our daily activities? Have we started seeing a shift in the approach by industry? How do we encourage this?  The aim is to initiate a collaborative discussion, share how different approaches could be implemented to address this change and how quality could be the driver for that change.

The CSV Chicken or the (Unscripted) Egg. What Came First: Regulator Intent or Industry Pioneers?

Despite its growing success, it is still not mentioned in any regulations or guidelines, nor has it yet been publicly endorsed by regulators in the UK or EU. This presentation will explore what unscripted testing really is, where it came from, how it was intended to be used, and to answer the question once and for all: what came first, the need for unscripted testing or the expectation to test differently.

Mind the Gap: Closing the Distance Between Findings and Fixes

This session explores how clearly defining systemic risks, strong accountability structures, and a culture that supports genuine problem solving are essential for moving beyond superficial fixes toward sustainable improvement. It also outlines how robust CAPA practices, clear responsibilities, and effective change management principles can close the gap between recognising issues and achieving real, measurable outcomes.

When Harry Met Sally: Practical Collaboration Between GCP QA and IT in Computerised System Validation

This session will explore common misunderstandings in computerised system validation and provide a structured, risk-based approach to assessing validation documentation, governance, and roles and responsibilities. Delegates will gain practical insight and increased confidence to navigate computerised system validation within GCP environments, strengthen collaboration with IT, and support compliant system lifecycle management.

Risk Proportionality Panel

A multi-regulator discussion of risk proportionality in practice — where proportionate approaches are working, and where expectations still diverge.