2025 European QA Virtual Conference

Advanced Therapy Medicinal Products (ATMPs): Constructing GLP Compliance in Preclinical Studies

The preclinical toxicology studies enabling the clinical phase are conducted under Good Laboratory Practice (GLP) principles, following international guidelines such as the FDA, OECD, EMA and ICH. These guidelines are well-established for traditional small molecules drugs. However, applying them to Advanced Therapy Medicinal Products (ATMPs), which include Gene Therapy Medicinal Products (GTMPs), Somatic Cell Therapy Medicinal Products (sCTMPs), Tissue Engineered Products (TEPs) and Combined ATMPs, is sometimes not straightforward and poses for some significant challenges.

ATMPs introduce a range of complexities that require a product-specific approach during preclinical development that can be managed only with specific tailored âad hocâ quality risk assessments. Variability in delivery mechanisms, active ingredients, and routes of administration presents unique obstacles. Managing studies in compliance with GLP for ATMPs involves addressing challenges such as Test Article characterisation, manipulation, formulation, formulation analysis, stability assessments, and defining relevant acceptance criteria. Additionally, surgically based in situ administration demands careful planning and execution, while endpoints in study protocols must be clearly defined and managed to ensure reliable and interpretable results.

This presentation highlights the recent experience of Evotec's GLP Test Facility in addressing these challenges ensuring GLP compliance and data integrity. Over the past few years, the facility has refined its processes to tackle the complexities associated with ATMPs. Key strategies include conducting detailed quality risk assessments and implementing process improvements to mitigate potential issues. These efforts have strengthened the management of critical study components, including Test Article preparation, advanced administration techniques, and endpoint evaluations. This approach has enabled the generation of robust toxicology and biodistribution data for ATMP-based test items, ensuring that preclinical studies meet both scientific and GLP expectations.

Windsor Framework

The Windsor Framework, which came into effect on 1st Jan 2025, has changed the legal landscape and Pharmacovigilance requirements for medicines licensed in the UK. This talk will cover the impact of the Windsor Framework. Attendees will learn the impact of the Windsor Framework on medicines approved through different licensing routes and areas to consider when conducting PV audits.

Remote Auditing : Best Practices, Tools, and Strategies

Remote auditing has emerged as a vital practice for ensuring compliance, quality, and operational efficiency in an increasingly remote and globalised work environment. This presentation will delve into essential tools and technologies that enables seamless remote collaboration and strategies for overcoming common challenges. By implementing these insights, businesses can be conduct audits with more efficiency adhering regulatory standards and drive continuous improvement.

Impact of Organisational Transformation on QA Teams and Quality Management Systems

Organisational change, including mergers, acquisitions and divestments, is an ever-present reality in the clinical trial sector. While such transformations can unlock opportunities for growth, they also pose significant challenges for Quality Assurance (QA) teams and Quality Management Systems (QMS). 

This session explores how QA professionals can proactively address the complexities of organisational change, ensuring compliance, maintaining data integrity, and fostering a culture of quality during times of transition. 

Key topics include: 

- Understanding the ripple effects of organisational changes: How structural shifts influence QA roles, responsibilities, and workflows within clinical trial organisations. 

- QMS integration and adaptation: Strategies to harmonise diverse QMS during mergers and ensure robust quality frameworks post-divestments. 

- Maintaining compliance amidst disruption: Leveraging risk-based approaches to meet GCP, GVP, and other regulatory standards during organisational transitions. 

- Empowering QA teams during change: Building resilience, adaptability, and collaboration within QA teams to navigate uncertainty effectively. 

Through real-world insights and actionable strategies, this session will provide QA professionals and organisational leaders with the tools to turn disruption into an opportunity for continuous improvement and strategic advancement. By embracing the principles of quality and integrity, attendees will learn how to support their teams, safeguard trial outcomes, and maintain trust with stakeholders through periods of transformation. 

Join us to uncover how to make organisational change not just manageable, but a driving force for progress in the clinical trial sector. 

The Role and Influence of Sponsors in GLP Studies: A Complete Overview for Ensuring GLP Compliance

Sponsors are crucial for funding GLP studies that assess product safety and effectiveness, but their influence can lead to bias in study design and outcomes through selective reporting and pressure for specific results.

To reduce this influence, three strategies should be prioritised: transparency to identify conflicts of interest, regulatory oversight to enforce standards, and promoting independence in study execution and analysis to maintain scientific integrity. In summary, while sponsor influence can undermine GLP study integrity, prioritising transparency, oversight, and independence can help protect research validity and public health.

GLP QA Clinic

Bring your questions, queries and scenarios for discussion or listen in to what the GLP committee and your peers in RQA are seeing as issues / bottlenecks / areas of concern and potentially learn how others have overcome such challenges.  From Test Items and data integrity, to oversight of clinical labs and what questions labs are getting regarding R3, this is an opportunity to collaborate with your industry peers on the challenges of not just today but maybe tomorrow too.

Conducting Effective Internal Audits from a Distance

As a QA Manager for several organisation across the UK it is not effective use of time to visit sites frequently. This approach developed through necessity but also has and impact on environmental, efficiency and cost savings. The presentation will provide insights into:

1. decisions on which audits can be conducted remotely or hybrid and how this is used to designed the audit programme

2. application of technology

3. the evolution of the QA programme

The challenges and lessons learned during the evolution of using remote audits for the internal audit programme.

Finding Purpose in Quality: How to Make QA More Than Just a Job

Quality assurance isn’t just about compliance - it’s about impact. Whether you're new to QA or years into your career and feeling disconnected, this session will help you rediscover the purpose behind what you do.  

From ethical dilemmas to decisions that ripple across an organisation, we’ll explore how QA professionals - at any stage - can cultivate a quality mindset that goes beyond ticking boxes. This session will reframe QA as a mission to drive transparency, proactively assess risks, and influence organisational behaviour towards a culture of integrity.  Through real-world stories and thought-provoking insights, we’ll challenge the perception that QA may just be focused on rules, procedures and issues. Instead, we’ll explore how it can create an environment where teams feel empowered to surface problems without fear, embed quality into daily decisions, and contribute to a stronger, more resilient and proactive organisation.  

Join us to uncover:

• How to turn everyday QA tasks into meaningful contributions that shape organisational success.

• The butterfly effect of small decisions - how proactive risk assessment and quality by design prevents failures.

• How to be a lighthouse, not just a watchdog in your organisation - influence a quality culture, where transparency and critical thinking is the norm and continuous improvement thrives.

• The QA Hero’s Journey - navigating obstacles, growth, and purpose while fostering trust and collaboration.  

If you've ever asked yourself, "Is my role in QA really making a difference?", this session is for you. Quality isn’t just about checking compliance boxes - it’s about building a culture where problems can be raised, risks are managed before they escalate, and every decision contributes to scientific integrity and patient safety. It’s time to make quality personal - because when you see the bigger picture, every task, decision, and challenge gains new meaning.

AI and Pharmacovigilance Auditing

This presentation aims to explore the transformative impact of Artificial Intelligence (AI) on pharmacovigilance auditing. AI automates data collection and analysis, significantly reducing audit times and improving the precision of detecting adverse drug reactions. Advanced algorithms enhance accuracy, while AIâs ability to identify patterns and anomalies enables proactive risk mitigation.  The presentation aims to highlight the key benefits and future trends of AI in the critical field of auditing.

Effective Conflict Resolution: Navigating Challenges in QA Teams and Audits

In the world of Quality Assurance (QA), conflicts often arise due to differing perspectives, high-pressure environments, and the complex nature of regulatory compliance. Whether it is between team members, departments, or external stakeholders, the ability to effectively manage and resolve conflicts is essential for maintaining a productive, compliant, and harmonious work environment. This session will focus on conflict resolution strategies that QA professionals can use to address challenges within their teams and during audits, ensuring smooth operations and fostering a culture of collaboration.

OECD Document 25 for the non IT Auditor

OECD Document 25 has brought in to focus IT security in GLP facilities.  This presentation will highlight the key points of this documents for the non-IT QA professional to look for whether you're conducting vendor audits or supporting your organisation in assuring their continuing compliance with the current regulatory expectations.

The Brittleness of (a)RMM PV Auditing and Strategies for Enhancing its Viability

Sometimes, a prerequisite for granting or maintaining marketing authorisation, Risk Minimisation Measures (RMMs) requirements come as pearls of patientâs safety. However, in reality, the complexity between routine and additional RMMs, multiple stakeholders,  company structures, outsourcing, ever-changing global and local requirements, and technology are putting pressure on pharmacovigilance (PV) audits to make the impossible possible.

This presentation will focus on:

1. Examining the complexity and challenges faced by the PV auditing group when planning PV audits, as well as those faced by PV auditors when conducting  audits such as, for instance: understanding requirements, business structure while scoping audits focusing and following riskchanging audit methodologies to match complexity of the (a)RMM implementation process

2. Providing insight of common findings from the audits and inspections, as well as  guidelines on what considerations should be taken into account for planning, and conduct of (a)RMM PV audits

3. Following this year's RQA theme on Mission: Quality is Possible, this session will provide some practical guidance and encourage the audience to engage: 

• If RMMs are pearls of patient safety, what can we, as PV auditors, do better to influence the planning and conduct of (a)RMM PV audits?
• Can we be the superheroes for patients and if not us, then who?

Audit? What is the Point?

Have you ever considered challenging a person, department or organisation that has requested an on-site audit be conducted prior to signing a contract, before you have any real experience with the site?  This session explores some options, other than an audit, for obtaining the necessary information to assess a vendor during selection, which can help you to understand how the companyâs systems operate and identify gaps in GMP control and compliance. This, along with experience during initial activities, highlights areas which can be explored further during a more project and risk focussed on-site audit.

A Career Path in Quality

This session will present the diverse QA roles and responsibilities within the GxP Quality Assurance field and describe the range of QA opportunities involved in such develop and implement Quality Management Systems, conduct a range of audits (internally / externally) and ensure regulatory compliance within the pharmaceutical product lifecycle.  Careers in QA offer growth and opportunities to span your knowledge across several GxP’s and valued areas of the industry as well contributing to public health.

QA in Crisis: Driving Resilience During Operational Breakdowns

When operational crises arise, the role of Quality Assurance is often seen as limited to identifying issues for operations to resolve. But could QA do more? How can QA professionals move beyond problem-spotting to become a pivotal part of the solution?

This session challenges traditional perceptions of QAâs role, exploring how QA can balance its independence with a collaborative, value-driven approach that not only addresses immediate issues but also strengthens organisational resilience. Drawing on real-world case studies of operational failures, this session examines common pitfalls in crisis response, which often add complexity to the process, rather than addressing inefficiencies.

Participants will explore how QA can contribute to not just identifying the issue but rethinking processes to make them more streamlined, efficient, and effective. By focusing on improvement QA can build trust with operations and help craft solutions that prevent recurrence while enhancing overall performance. By the end of this session, participants will be equipped to turn crises into opportunities for enhancing quality systems and demonstrating the true value of QA as a strategic partner.

More Engaging and Memorable Trainings - Making Quality and Compliance Possible

With GxP requirements and study protocols getting more complex, and time constraints tighter, it is pivotal to allow to all GxP players (from Sponsors and Service Providers staff to Investigator Sites team members) to effectively absorb and then reasonably apply the GxP and project-specific information. Innovative approaches like animation, gamified tests and quizzes, are an important option here - particularly compared to dozens and hundreds pages of text, or hundreds of slides in the good old presentations. And yes - this applies to regulations and study-specific materials.

Industry Viewpoints on Pharmacovigilance Inspections

The presentation takes you through the different inspection types, i.e. GCP/GMP/GVP/For Cause where pharmacovigilance requirements are reviewed.   The various different types of inspectorates from around the world are then summarised.  The purpose of the presentation is to leave the audience with a broad understanding of the landscape of GVP inspections and what considerations are needed to manage these.

Tackling Operational Challenges and Shaping the Future of Quality Assurance

Pamela will present on Operational Challenges and Emerging Trends in Quality Assurance, with a dual focus on these key areas:

1) Operational Challenges  

-Addressing the evolution of remote auditing and its influence on maintaining quality standards.  
-Strategies for handling unforeseen challenges in global quality operations without sacrificing regulatory alignment.  

2) Emerging Technologies and Trends  

-Leveraging AI to enhance data-driven decision-making in QA processes.  
-Understanding the role of digital transformation in delivering operational excellence and agility within quality frameworks.

Communicating with Impact: Strategies to Bridge Gaps and Build Trust

Regulatory knowledge is essential in QA, but effective communication is what turns observations into meaningful change. Whether engaging with operations, sponsors, or senior management, QA professionals need to handle complex conversations, build trust, and make sure their message is understood.

This session explores practical strategies to enhance communication at every level of QA. We’ll break down common barriers between QA and operational teams, uncover the subtle skills that strengthen interpersonal connections, and discuss how to adapt messages for different audiences—whether delivering critical feedback, facilitating audits, or influencing change. Finally, we’ll explore how feedback can be more than just a box-ticking exercise and instead become a tool for continuous improvement and growth.

Through real-world examples, this session will provide actionable insights that QA professionals can immediately apply. Whether you’re a seasoned auditor or just starting your career, mastering these communication strategies will elevate your impact and strengthen relationships. Join us to challenge old habits and discover how communication can be your most powerful QA tool.

Are Current Trainings on Quality Fit for Purpose?

The principles of quality are at the heart of process improvements within companies.  But how well are they understood? Establishing a culture of quality also involves training and understanding what quality means and how teams can apply it. This session is meant to be interactive and engaging by better understanding how we can improve training of employees.

Quality Assurance: Process for the Sake of Process?

Anna will outline the changing regulations, the changing technologies and give some real life examples where the auditor's findings were not result-oriented but far too formal. She will touch on digital QMS and discuss whether QA is the auxiliary tool or the power in itself.

How GCP QA Can Support Inspection Readiness During Study Conduct

In this session, we'll look at how Quality Assurance can work with clinical study teams to encourage 'inspection readiness by design' by working with the teams during study start-up and conduct to promote risk-based approaches, documented adherence to written requirements, participant protection, record integrity, and effective oversight. We'll discuss techniques to encourage those actions, including pre-milestone process reviews, modelling critical thinking, risk-based audits, and value-added CAPA approaches.

A Risk-Based Approach to Risk Based-Approaches: Ever Decreasing Circles, or a Beacon of Hope?

A risk-based approach to risk based-approaches: Ever decreasing circles, or a beacon of hope?

In modern clinical research, risk management is one of the hottest topics. The question is: does anybody really do it well?

This session will explore innovative and pragmatic approaches to risk management, and hopefully unravel some of the mysteries and misconceptions around the subject.The concept of risk-adapted approaches within clinical trials was first introduced in 2011 with the publication of the joint MRC/DH/MHRA paper on the subject. Ever since then, risk has been extensively discussed, analysed and explored. Why then does it seem that Sponsor organisations still struggle with risk assessment and management?

The speaker will take the audience on a journey into risk-based approaches, using just that: a risk-based approach. The session will look at different elements of clinical research, including developing a protocol, identifying service providers, and running the trial itself with all of the monitoring and oversight that entails.

The speaker's aim is for the audience to conclude that risk management is the most powerful tool available to a Sponsor organisation; what many see as a tick-box exercise is actually a formidable weapon against inefficiencies. The Quality professionals within those Sponsor organisations can be the secret agents that ultimately help to get the job done, if they choose to accept that mission..!

Mission: Risk Possible - Mastering Quality Risk Management in GxP

Quality Risk Management (QRM) is an essential tool for ensuring compliance, optimising resources, and maintaining data integrity across all GxP areas. But what exactly is a risk? How do we manage it effectively? And where do regulatory principles expect us to apply risk management?

This session from the RQA Support and Grow Special Interest Group will explore the fundamental role of QRM in GxP regulations, highlighting real-world examples of how risk-based approaches are successfully applied in each domain. Whether you’re new to GxP or looking to solidify your understanding, this session will provide the essential knowledge and tools needed to integrate effective risk management into your daily work. Join us for an exciting deep dive into the world of QRM - because in quality assurance, managing risk isn’t just a necessity; it’s an opportunity to drive excellence.

Digital Preservation: Achieving Long-term GxP Data Quality and Integrity

This presentation is about the challenges and solutions to long-term data quality when retaining and archiving GxP data.  Topics include regulatory requirements, data criticality and data integrity risks, the importance of archiving and digital preservation good practice, and how to deliver verifiable long-term data quality and integrity to ensure retained GxP data is both compliant and can be reused with confidence.

Creating a GLP Procedure System from Scratch

The establishment of a Good Laboratory Practice (GLP) study system is critical for ensuring the quality, integrity, and reliability of non-clinical safety studies that support regulatory submissions. Building such a system from scratch requires a comprehensive approach encompassing the design and implementation of key components, including organisational frameworks, procedural guidelines, quality assurance mechanisms, and technology infrastructure. This paper outlines the methodology for creating a GLP-compliant study system, emphasising the integration of robust data management systems, standard operating procedures (SOPs), and quality assurance protocols. The process involves stakeholder engagement, alignment with regulatory standards, and continuous training for personnel to uphold compliance and efficiency. The study also examines challenges such as resource allocation, adaptation to evolving regulatory requirements, and maintaining consistency across multidisciplinary teams. By presenting a step-by-step framework, this work serves as a guide for organizations seeking to build a GLP study system that ensures scientific rigor, regulatory compliance, and reliability in the generation of non-clinical safety data.

Bridging GxP and Data Privacy

GxP and Data Privacy Adherence in Pharma and MedTechIn this digital era, every industry is keen to adhere to the statutory and regulatory obligation to run a business. Especially in pharma & MedTech, the large data play a vital role for a meaningful outcome. Data privacy is one of the mandatory requirements to safeguard both individuals and organizations doing business in an ethical way.

Leveraging Generative AI to Transform Quality Assurance Practices: Practical Applications and Lessons Learned from Real-World Implementation

This session explores the transformative potential of generative AI (GAI) in enhancing quality assurance (QA) practices, providing attendees with practical examples and strategic insights from real-world implementations.

Through applications such as RFI responses, assessing regulatory changes, classifying non-conformities, and identifying safety issues in clinical trials, the session highlights how GAI can streamline processes, foster innovation, and strengthen compliance.

Attendees will gain actionable insights into overcoming challenges such as data quality and bias, empowering their QA teams to responsibly leverage GAI for improved efficiency and proactive decision-making.

How does the Integration of ICH E8(R1) and ICH E6(R3) Enhance the Quality of Clinical Trials?

The implementation of ICH E8(R1) affect the adoption of ICH E6(R3). The combined insights of these guidelines elevate the quality of clinical trials by aligning their complementary principles and establishing a comprehensive, flexible and risk-based approach to trial design and conduct. This synergy between the two guidelines establishes a more robust framework for ensuring high-quality clinical research.

The presentation will explore the transformative impact these guidelines have on shaping the future of clinical trials, emphasising the safety, rights, and well-being of trial participants, as well as focusing on innovative, effective, and reliable trial results.

Technological implications of the new GCP ICH E6 (R3)

The updated Good Clinical Practice (GCP) guideline (ICH E6 R3), released on 14th January 2025, marks a long-anticipated milestone in the clinical research industry. It addresses the evolving landscape of clinical research, emphasising the integration of emerging technologies, innovative solutions, digitalisation, and cloud-based workflows. Notably, the updated guideline provides greater clarity on data governance, underscoring the importance of a comprehensive data lifecycle framework and imposing stricter requirements for the management of computerised systems.

While the industry has made strides in addressing these areas over the past few years, the new guideline establishes a standardised baseline for all stakeholders, including sponsors, contract research organisations (CROs), suppliers, investigators, and regulatory authorities. These expectations will soon manifest in regulatory inspections and audits, reinforcing the need for organisations to ensure their processes and tools - particularly software solutions- comply with the new GCP standards.

This session will guide the audience through the process of assessing their current systems against the updated GCP requirements, identifying gaps, and implementing effective solutions. Practical advice and a structured framework will be provided to help translate these insights into actionable plans, setting participants on a path to compliance and long-term success.

Additionally, we will explore how the updated GCP represents a paradigm shift in the perception and utilisation of technology and software. It necessitates a transformation in the approach to quality assurance and compliance, empowering organisations to adapt proactively to this evolving landscape.By the conclusion of this session, participants will:

a) Gain a clear understanding of their current technological landscape in relation to the new GCP expectations.

b) Be equipped to develop a process improvement plan to achieve compliance with the updated GCP standards.

c) Establish a vision and timeline for achieving their goals.

Triple Agent Protocol: When Three Forces Converge in Vendor Management

Your mission, should you choose to accept it, is to master the three critical elements of vendor management in clinical trials. Like any IMF operation, success depends on perfect synchronization - in this case, of Process, Data, and Communication working in harmony as the Fire Triangle of Vendor Management.This briefing will equip you with classified intelligence on the "3 Es" protocol (Expectations, Engagement, Escalation) and demonstrate how to prevent your vendor management mission from self-destructing.This message will self-destruct in 45 minutes, followed by a 15-minute debrief.Target clearance level: Intermediate to AdvancedOperative specialties: Quality Assurance, Clinical Operations, Vendor Management

The Future of QMS in Pharma: AI and SMART Standards Driving Intelligent Compliance

This session explores how machine-readable SMART standards and Artificial Intelligence (AI) are revolutionising Quality Management Systems (QMS) in the pharmaceutical industry by enabling real-time, automated compliance and adaptive quality workflows.

Attendees will learn how initiatives like the CEN-CENELEC SMART Standards Project and AI technologies align with global regulatory frameworks such as GCP E6(R3), FDA, and EMA guidelines, driving structured data governance and proactive risk management.

Practical examples will highlight the transformative potential of these innovations, offering a roadmap for creating scalable, intelligent QMS frameworks that address future regulatory and operational challenges.

Role of Artificial Intelligence (AI) in Inspection Readiness

In the world of Quality Assurance (QA), conflicts often arise due to differing perspectives, high-pressure environments, and the complex nature of regulatory compliance. Whether it is between team members, departments, or external stakeholders, the ability to effectively manage and resolve conflicts is essential for maintaining a productive, compliant, and harmonious work environment. This session will focus on conflict resolution strategies that QA professionals can use to address challenges within their teams and during audits, ensuring smooth operations and fostering a culture of collaboration.

Smart Audits- From Manual to Automated: How AI is Shaping the Future of Audit Planning and Execution

By leveraging tools such as machine learning, natural language processing, and predictive analytics (like Microsoft Copilot AI, Veeva Vault QMS, Sparta Systems, TrackWise Digital, MasterControl, AuditBoard) AI enhances key audit functions including risk assessment, audit planning, and compliance tracking, ensuring more efficient, accurate, and data-driven audits.

While addressing the challenges of AI integration, the paper highlights its transformative potential in streamlining audit processes, improving decision-making, and ensuring compliance with complex regulatory standards.

RBQM in Action: Staying Ahead of Risks Before They Become Issues

As clinical trials grow in complexity, risk-based quality management (RBQM) is no longer optional. It is essential.

This session will explore how proactive risk identification and proportional mitigation, as emphasised in ICH E6(R3), can prevent risks from escalating into costly compliance and operational issues. We will discuss how sponsors and CROs can implement a dynamic risk-based approach that aligns with regulatory expectations while improving trial efficiency and patient safety.

Attendees will gain practical insights into integrating risk proportionality principles into their quality oversight strategies.

Global Serious Breach Reporting Requirement and Real Life Examples

A reminder of SB requirements globally, highlighting any new requirements / changes. Using real world examples, discuss with the audience if cases meet reporting requirements and provide information on the outcome of any reports made (whilst maintaining confidentiality). Focus on experience of submitting to the EMA via CTIS.

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

ICH E8(R1) and E6(R3) recommend a dynamic and risk-based approach to the quality management strategy for a medicinal product development programme. 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 Critical to Quality Assessment Methodology is the latest initiative developed by the Inter-Company Quality Analytics (IMPALA) consortium. The methodology, which is an iterative process conducted throughout a clinical trial, starts with the identification of CtQ factors for the study and associated risks that may threaten their integrity, followed by development of the initial quality strategy based on this evaluation. It continues with the generation of quality evidence through the execution of a variety of activities, including quality assurance audits, utilising both traditional and analytical methods. From there, quality conclusions are determined and documented in the Critical to Quality Assessment Report (CAR). The purpose of the presentation is to share the details of this methodology and to describe the value proposition of the CAR for internal and external stakeholders.

Navigating the AI Regulatory Maze: Between the Laws, Standards, and Governance Practice

This presentation will show the current state of the global laws, including but not limited to the AI Act, technology standards, like ISO 42001 AI Management System, unique regulations in the pharmaceutical sector, combined with data protection aspects as well as ethical principles, creating a challenging homeostasis for structured AI governance programmes.

The presentation will also provide a unique focus on the use cases from other industries that are already successfully implementing AI systems and what the pharmaceutical industry can learn from them.

GCP QA Clinic

Members of the RQA GCP Committee present the GCP Clinic, discussing hot topics through prepared presentations and live Q&A's. An interactive session that allows you to be a part of the conversation with industry representatives.

IRMS - Revolutionising GCP Risk Management

The Integrated Risk Management Solution (IRMS) revolutionises GCP risk management by fostering cross-functional collaboration and connecting risks at various levels. It frees up time for critical thinking, enhancing the ability to identify and address unique risks and mitigations. Designed to address forthcoming ICH E6 changes, IRMS serves as a central hub for managing risks across studies, processes, vendors, and sites.

Beyond Audits: Innovative Approaches to Compliance Monitoring and Quality Systems

Traditional audits have long been the cornerstone of quality assurance, but evolving regulatory expectations, resource constraints, and the dynamic nature of GxP environments demand a more agile and continuous approach to compliance monitoring. This session explores alternatives to conventional audits, focusing on innovative strategies that enhance oversight, improve risk detection, and drive quality culture beyond scheduled inspections.

Overlaps between GCP and GVP Audits

Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) are two critical frameworks in the pharmaceutical and healthcare industries. GCP focuses on the ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects. Its primary aim is to ensure the safety, rights, and well-being of trial participants, as well as the integrity of the data collected.

Auditing in GCP involves:

- Verification of Compliance: Ensuring that clinical trials are conducted in accordance with the approved protocol, GCP guidelines, and regulatory requirements.

- Data Integrity Checks: Confirming that the data collected during the trial is accurate, complete, and verifiable from source documents.

- Participant Safety Audits: Assessing whether the rights, safety, and well-being of trial participants are protected throughout the trial.

On the other hand, GVP encompasses the processes and systems used to monitor the safety of post-marketing drugs. It aims to identify, assess, and manage risks associated with medicinal products, ensuring that any adverse effects are promptly reported and assessed.Auditing in GVP involves:

- Risk Management Audits: Evaluating the effectiveness of risk management plans and strategies to minimise risks associated with medicinal products.

- Case Management and Safety Reporting Audits: Ensuring timely and accurate case management and reporting of adverse drug reactions and other safety-related information.

- Compliance Audits: Verifying that pharmacovigilance activities comply with regulatory requirements and GVP guidelines.

- Description of PV System: Interface with GCP (procedures, compliance, data, etc.)     

The presentation will conclude by highlighting the key overlaps between GCP and GVP, emphasising the importance of regulatory compliance, data integrity, and participant/patient safety in both practices. It will underscore the necessity of robust documentation and reporting mechanisms to maintain transparency and accountability.

The conclusion will also stress the significance of continuous improvement in auditing practices to enhance the overall quality and safety of clinical trials and pharmacovigilance activities.Both GCP and GVP audits are essential to maintaining high standards of safety, data integrity, and regulatory compliance in the pharmaceutical and healthcare industries.

Perspectives for Potential Means of Validation of AI and ML in Digitised Quality Assurance

The integration of Artificial Intelligence (AI) and Machine Learning (ML) into Quality Assurance (QA) processes in the pharmaceutical and biotechnology industries offers transformative potential, enabling predictive analytics, real-time monitoring, and enhanced decision-making. However, the validation of AI and ML systems remains a critical challenge, given their complexity, dynamic nature, and the stringent regulatory requirements of the industry.

This presentation explores potential means of validating AI and ML models in QA, focusing on ensuring reliability, transparency, and compliance. Key perspectives include the development of robust validation frameworks, the use of explainable AI (XAI) to enhance model interpretability, and the implementation of continuous monitoring and re-validation strategies. Additionally, the presentation highlights the importance of collaboration between industry stakeholders and regulatory bodies to establish standardised guidelines for AI/ML validation. By addressing these challenges, the industry can harness the full potential of AI and ML while maintaining the highest standards of quality and safety. This session will provide valuable insights for professionals seeking to navigate the evolving landscape of digitised QA.

Automation Over AI - Ensuring Compliance in Quality Assurance

The focus of our session will be on why automation is a more reliable, compliance-driven solution compared to AI in regulated environments.

The presentation will explore how automation ensures consistency, traceability, and audit readiness whilst also addressing challenges such as remote audits, decentralised trials, and risk management. Attendees will also gain insights into integrating automation into Quality Management Systems (QMS) to help drive innovation, reduce risks, and maintain regulatory excellence.