Please note that due to unforeseen circumstances, the programme is subject to change. All times are in BST.
08.00
15mins
Opening of the conference
08.15
45mins
In today's fast-changing regulatory landscape, quality assurance (QA) professionals face a crucial mission: to embrace digital transformation as an immediate necessity rather than a distant possibility. This discussion will explore how QA professionals can evolve from traditional compliance enforcers to digital pioneers, guiding their organisations through technological disruption while upholding rigorous quality standards. Read More.
View pop upFabrizio Maniglio, Industry and Business Development Director, Honeywell
In today's fast-changing regulatory landscape, quality assurance (QA) professionals face a crucial mission: to embrace digital transformation as an immediate necessity rather than a distant possibility. This discussion will explore how QA professionals can evolve from traditional compliance enforcers to digital pioneers, guiding their organisations through technological disruption while upholding rigorous quality standards.
The digital revolution has introduced powerful new tools such as artificial intelligence, advanced analytics, cloud validation, and remote auditing technologies. These innovations fundamentally reshape the way quality is defined, measured, and ensured. Rather than merely enhancing existing QA processes, they facilitate the goal of quality assurance: predictive quality systems that can identify and mitigate risks before they arise.
By leveraging real-time data analytics and AI-driven insights, QA professionals can anticipate compliance issues, forecast quality trends, and transition from reactive to proactive quality management. This paradigm shift transforms the daunting task of ensuring perfect quality into an achievable reality.
Using compelling case studies and practical frameworks, we will demonstrate how forward-thinking QA teams are already utilising these technologies to shorten inspection times, improve data integrity, and attain unprecedented levels of quality assurance. Attendees will gain a clear understanding of the digital QA toolkit, strategies for overcoming implementation challenges, and a practical roadmap for leading digital transformation initiatives within their organisations.
If you accept this challenge, your mission is to become an agent of digital change, turning the impossible into the possible and making predictive quality an operational reality, rather than just a theoretical aspiration.
09.00
60mins
Use this time your way: relax, network, or join a discussion
10.00
60mins
A general overview/intro to the main changes to E6 and positioning.
Peter Twomey, Head of Inspections, EMA
11.00
30mins
The EU AI Act introduces a transformative regulatory framework designed to promote the safe and ethical use of AI across industries. Read More.
View pop upMaria Veleva, Director and Owner, Velev Consulting Ltd
The EU AI Act introduces a transformative regulatory framework designed to promote the safe and ethical use of AI across industries.
This presentation will explore its implications for quality management systems, focusing on practical strategies to achieve compliance while maintaining innovation. Attendees will gain insights into the Acts key provisions and their impact on quality assurance in regulated environments.
60mins
As organisations navigate the convergence of ICH E6 R3 and the FDA's Computer System Assurance (CSA) guidance, quality executives face dual imperatives: enhancing clinical trial quality management while streamlining computer systems validation. Read More.
View pop upMatt Jones, Managing Director, Digital Quality Associates
As organisations navigate the convergence of ICH E6 R3 and the FDA's Computer System Assurance (CSA) guidance, quality executives face dual imperatives: enhancing clinical trial quality management while streamlining computer systems validation. This presentation demonstrates how fractional IT quality support enables organisations to implement both frameworks efficiently. We examine how CSA's critical thinking approach aligns with R3's risk-based quality management, particularly in areas of electronic systems validation and data integrity. The discussion covers practical strategies for applying CSA's testing prioritisation model alongside R3's requirements for electronic trial master files and remote monitoring capabilities. Case studies illustrate successful implementation of unscripted testing for lower-risk systems while maintaining stringent validation for critical applications. The framework presented helps organisations leverage shared principles between CSA and R3 to optimise validation efforts, reduce documentation burden, and enhance system quality assurance through targeted IT support models.
30mins
The Pharmaceutical Quality System (PQS) is always a focus of regulatory inspections, whether that be documentation, deviations, changes or CAPA effectiveness...Read More
View pop upKay Hukin, Executive Director, NSF Life Sciences
The Pharmaceutical Quality System (PQS) is always a focus of regulatory inspections, whether that be documentation, deviations, changes or CAPA effectiveness yet it is consistently an area of non-compliance observations. Why? The PQS should be seen as a holistic function with all individuals and teams operating in harmony to identify, impact assess and resolve deficiencies quickly, thereby mitigating future risks.
11.30
30mins
The integration of Artificial Intelligence (AI) into Quality by Design (QbD) offers transformative potential for enhancing the efficiency, accuracy, and adaptability of clinical trials. Read More.
View pop upJamila Joseph, Senior Director, IQVIA
The integration of Artificial Intelligence (AI) into Quality by Design (QbD) offers transformative potential for enhancing the efficiency, accuracy, and adaptability of clinical trials. AI technologies, such as machine learning, natural language processing, and predictive analytics, complement QbD by optimising trial design, improving patient recruitment and retention, enabling real-time monitoring, and enhancing data integrity. However, challenges such as data privacy, regulatory acceptance, and potential bias in AI models must be addressed to realize its full potential. This presentation explores the synergy between AI and QbD in clinical trials, highlighting key opportunities, challenges, and future directions for this innovative approach.
30mins
Leading the Way from Compliance to Leadership: How Soft Skills Drive Compliance and Quality in GxP, explores the critical role of soft skills such as communication, leadership, and emotional intelligence alongside technical expertise in the success of Quality Assurance (QA) professionals within GxP-regulated industries. Read More.
View pop upJanki Soni, Lead/Senior Principal, Clinical & Medical Quality, Alvotech
Leading the Way from Compliance to Leadership: How Soft Skills Drive Compliance and Quality in GxP, explores the critical role of soft skills such as communication, leadership, and emotional intelligence alongside technical expertise in the success of Quality Assurance (QA) professionals within GxP-regulated industries. By empowering QA teams with these interpersonal tools, organizations can improve team dynamics, enhance performance, and drive better compliance outcomes, ultimately ensuring higher standards of safety and efficacy in regulated environments.
12.00
60mins
Use this time your way: relax, network, or join a discussion
13.00
60mins
This will be an interactive session exploring the management of deviations in veterinary clinical studies. Read More.
View pop upSven Buckingham, Director, Buckingham QA Consultancy Ltd
Lindsay Heasman, Director, Hurst Animal Health Ltd
George Winthorpe, GXP QA Manager, Animal and Plant Health Agency
This will be an interactive session exploring the management of deviations in veterinary clinical studies. Differing scenarios will be presented together with suggested impact assessments and corrective and preventative actions (CAPA). The suggestions will include poor impact assessments/CAPA, followed by suggestions for better impact assessments/CAPA and then the (hopefully!) "best" impact assessments/CAPA.
60mins
In the covert world of Computerised System Validation (CSV), step-by-step screenshots are the secret agents we've relied on for too long, but is their cover blown? This presentation highlights data-centric strategies that replace outdated, screenshot-heavy practices with robust, efficient alternatives such as leveraging audit trails and system-generated reports. Drawing on intelligence from real-world validation, this presentation will introduce you with the tools to streamline CSV testing, enhance quality assurance, and reduce operational burden. Are you ready to uncover the secrets of intelligent validation in the age of data-driven espionage?
View pop upJohn Cheshire, CSV Consultant, Headway Quality Evolution
Your mission, should you choose to accept it, is to tackle one of the most persistent inefficiencies in Computerised System Validation (CSV): the reliance on excessive screenshots as evidence. Whilst screenshots have long been the "field operatives" of validation testing, their time-consuming nature and limited value in a digital landscape call for a smarter, more streamlined approach.
This presentation dives into the value of data-centric validation, focusing on strategies that prioritise audit trails and system-generated reports over repetitive, low-value evidence. By shifting to these robust methods, laboratories and organisations can not only reduce validation effort but also improve data integrity and quality assurance.This presentation will look at:
By the end of this session, participants will be ready to:
Join us as we rewrite the rules of validation and embrace the future of compliance - no disguises required.
Remember: This message will not self-destruct, but your validation headaches might just disappear!
30mins
In a world where technology is changing faster than ever, it can be tough for Trial Master File (TMF) teamsâwho work under strict rules and oversight to keep up and actually see the benefits of new technology. Read More.
View pop upAaron Grant, Head of Innovation, Just in Time GCP
In a world where technology is changing faster than ever, it can be tough for Trial Master File (TMF) teamsâwho work under strict rules and oversight to keep up and actually see the benefits of new technology.
This presentation looks at practical ways to implement cutting-edge solutions and approaches that have real operational benefit, while staying compliant. We will examine real use cases leveraging Generative AI, Voice assistants, NLP and more.
30mins
The presentation will explore strategies for effectively preparing for a closing meeting from the auditee's perspective. Read More.
View pop upDeepa Arora, CEO, Clinexel Life Sciences
The presentation will explore strategies for effectively preparing for a closing meeting from the auditee's perspective. It will highlight the importance of addressing audit findings, clarifying observations, and agreeing on corrective actions, while maintaining flexibility and open communication. Through case studies and actionable insights, the session aims to equip participants with actionable strategies to navigate the closing meeting process, foster collaboration, and ensure alignment with regulatory expectations and audit objectives.
13.30
30mins
With advances in Quality systems and processes, and the ever-increasing involvement of intelligent automation, we are getting better at managing quality. Read More.
View pop upIain Searle, Director, Training Strategy, Veeva Systems
With advances in Quality systems and processes, and the ever-increasing involvement of intelligent automation, we are getting better at managing quality.
But things still go wrong, and when they do itâs often the human in the process who is at fault. This session will explore how training approaches need to adapt to our evolving roles.
30mins
Audits and how we manage them has changed and adapted over the years, however at their core are still the people that complete the jobs. Read More.
View pop upGemma Berry Jones, Director, Head of Quality Operations, Nostrapharma Ltd
Audits and how we manage them has changed and adapted over the years, however at their core are still the people that complete the jobs. As a Lead Auditor you need to take the lead when things don't go to plan. The presentation will focus on three areas, technology, identification of new risks and management of people
14.00
60mins
Use this time your way: relax, network, or join a discussion
15.00
60mins
FDA inspections of Investigator sites, Sponsors and/or CROs for veterinary clinical studies are not that common in Europe. Read More.
View pop upSven Buckingham, Director, Buckingham QA Consultancy Ltd
FDA inspections of Investigator sites, Sponsors and/or CROs for veterinary clinical studies are not that common in Europe. In this session, we will look at FDA inspections of veterinary clinical study sites from three perspectives:
The aim is to give those based in Europe an understanding of how an inspection is performed based on shared experiences.
30mins
This session explores the advancements and challenges in achieving semantic interoperability between eHealth platforms and pharmaceutical data management systems. Read More.
View pop upHans de Raad, CEO, OpenNovations
This session explores the advancements and challenges in achieving semantic interoperability between eHealth platforms and pharmaceutical data management systems. It highlights the critical role of unified semantic models, international initiatives like Interoperable Europe and the European Health Data Space, and regulatory frameworks such as GCP E6(R3), EMA, and FDA guidelines in fostering seamless data exchange. Attendees will gain actionable insights into leveraging these developments to improve data governance, integrity, and cross-sector collaboration for enhanced patient outcomes across Europe.
60mins
In a world where more and more data resides above the clouds, the stakes for quality have never been higher. For many Quality Assurance professionals especially those without deep IT technical backgrounds, assessing Cloud Service Providers can feel like a mission straight out of a spy thriller.
But have no fear: Mission: Quality Is Possible when armed with the right strategies and tools!
Read More.
View pop upJoesph Turton, Consultant, CSV Specialist, Turton Consulting
In a world where more and more data resides above the clouds, the stakes for quality have never been higher. For many Quality Assurance professionals especially those without deep IT technical backgrounds, assessing Cloud Service Providers can feel like a mission straight out of a spy thriller.
But have no fear: Mission: Quality Is Possible when armed with the right strategies and tools!
This session will serve as your secret dossier on how to effectively evaluate Cloud Service Providers without being a tech wizard. You will learn:
Through real-world examples and Computerised System Validation (CSV) best practices, we will reveal how even the most 'non-techy' QA professionals can become skilled agents in safeguarding data integrity and regulatory compliance.
Join us to unlock the code for traversing cloud environments with confidence and discover how, with the right approach, Mission: Quality truly is Possible!
30mins
Technical expertise, regulatory knowledge, and direct experience are necessary prerequisites for auditors, but the human element highly influences the success of an audit. Read More.
View pop upAmy Wotawa, Senior Quality Assurance Manager/Auditor, Zigzag Associates Ltd
Technical expertise, regulatory knowledge, and direct experience are necessary prerequisites for auditors, but the human element highly influences the success of an audit. This presentation will explore how emotional intelligence and soft skills can transform your audit approach and shift the process from a transactional exercise into a collaborative, value-driven engagement. By building trust, managing difficult conversations, and aligning stakeholders on a shared commitment to quality and regulatory compliance, auditors become strategic partners. Insights into how a collaborative approach, informed by strong emotional intelligence and soft skills, can drive better audit outcomes, mitigate resistance, and promote lasting improvements will be discussed. This session is intended for auditors and Quality Assurance professionals looking to elevate their impact and make quality not just possible, but sustainable.
15.30
30mins
Over the past decade, the FDA has recalled over 14,000 drugs averaging almost 4 recalls per day.
In the Life Sciences sector, product recalls are crucial for safeguarding patient health and ensuring compliance. Fragmented data, delayed responses, and regulatory hurdles pose risks to both patients and organisations. Read More.
View pop upZillery Fortner, Industry and Business Development Director, SME, Honeywell Life Sciences
Abhishek Hiremath, Senior Product Manager, Honeywell Life Sciences
Over the past decade, the FDA has recalled over 14,000 drugs averaging almost 4 recalls per day.
In the Life Sciences sector, product recalls are crucial for safeguarding patient health and ensuring compliance. Fragmented data, delayed responses, and regulatory hurdles pose risks to both patients and organisations. A strong recall management system boosts operational efficiency by quickly identifying and removing harmful products, thus reducing public health risks. Life science professionals must prioritise these systems to protect patient safety and maintain healthcare integrity.
Join our insightful webinar exploring key challenges in recall management and discover how the NEW TrackWise Recall Management solution will address these issues. Get a sneak peek of this first-to-market solution via a short demo, showcasing how it can transform your recall processes through real-time visibility, AI-augmented decision support, and seamless system connectivity.
Key Takeaways:
Don't miss this opportunity to revolutionise your recall strategy and drive better outcomes for your organisation and patients.
30mins
In a world increasingly dominated by technology and instant access to the online realm, research shows that generations who experienced adolescence in this digital era are more prone to anxiety and depression, with weaker social skills compared to older generations. Read More.
View pop upAnna Lothian, Senior Associate, Tower Mains
In a world increasingly dominated by technology and instant access to the online realm, research shows that generations who experienced adolescence in this digital era are more prone to anxiety and depression, with weaker social skills compared to older generations. This digital shift has profoundly affected young people both socially and mentally, and as this generation begins to enter the workforce, it raises important questions about the future of QA professionals and the steps todayâs leaders must take to address these challenges and provide the necessary support.
16.00
60mins
Use this time your way: relax, network, or join a discussion
17.00
60mins
Our popular Question Time session - this time focusing on any questions from the day.
Use Slido to anonymously post and answer questions set by the rest of the attendees. Run by the RQA office. Speakers have also been invited to attend.
Come for the questions - stay for the answers!
08.00
30mins
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. Read More.
View pop upRiccardo Bazzoni, In vivo Toxicology Study Director, Evotec
Giulia Speziali, QA Specialist, Evotec
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.
30mins
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. Read More.
View pop upSarah Hall, Managing Director, Mipsol Limited
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.
30mins
Remote auditing has emerged as a vital practice for ensuring compliance, quality, and operational efficiency in an increasingly remote and globalised work environment. Read More.
View pop upAnand Balkrishna Pandya, QA Associate Manager, Labcorp Early Development India Private Limited
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.
60mins
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. Read More.
View pop upKatie Neville, Founder & Principal Consultant, QARA Consultancy LTD
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.
08.30
30mins
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. Read More.
View pop upHemangini Patel, Senior Quality Assurance Auditor, Battelle UK Ltd.
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.
30mins
This session will provide a summary and update from the EMA Risk Management Information Day held in Nov-2024. It will include highlights from EMA, MPA and MEB as well as industry experts in regard to implementation of updated GVP Module XVI and XVI Addendum II that came into force Aug-2024.
Natasa Mihajlovic, Managing Partner, NostraPharma Ltd
30mins
Working remotely during the Covid epidemic has shown that remote auditing can work and that it can work well. This presentation will cover solutions to difficulties faced during our remote auditing experiences and how we built our remote auditing processes to successfully expand our QA capacity by using a remote facility.
Amy Hastie, QA Associate Manager, Labcorp
09.00
60mins
Use this time your way: relax, network, or join a discussion
10.00
60mins
Join members of the GLP committee for a clinic on hot topics in GLP and GCP labs including take aways from recent symposia and regulatory / professional body discussions. Read More.
View pop upMichelle Manton, Associate Director, Laboratory Quality (UK/EU), R&D Quality & Compliance, Moderna
Vicky Massie, Consultant, VMQA Consultancy Services Ltd
Shona Ross, Head of QA, Tower Mains
Fiona Winder, GlaxoSmithKline, UK Director, Lab QA
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.
30mins
The usage of a Quality Circle team is a good method for reaching anytime inspection or audit preparedness. Organisations may assure compliance and operational excellence by encouraging continuous improvement and cultivating a collaborative culture.
Darshan Sakhia, Senior Manager, COD Research Private Limited
30mins
Insights to using remote audits as part of the internal audit program, applicable to GLP and GCP laboratories. How the audit program is designed, technology tools used, evolution of the QA programme and challenges and lessons learned (so you don't have to). Read More.
View pop upCate Ovington, Director, The Knowlogy Group Ltd
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.
60mins
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. Read More.
View pop upPaul Davidson, Quality Consultant, Headway Quality Evolution
Henrieke de Bie, Consultant Quality and Cultural Transition, Beyond Compliance
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.
10.30
30mins
This presentation aims to explore the transformative impact of Artificial Intelligence (AI) on pharmacovigilance auditing. Read More.
View pop upBarbara Bovy, -, UCB
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.
30mins
In the world of Quality Assurance (QA), conflicts often arise due to differing perspectives, high-pressure environments, and the complex nature of regulatory compliance. Read More.
View pop upAshok Kumar, Principal GxP QA Auditor, RiverArk
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.
11.00
60mins
Use this time your way: relax, network, or join a discussion
12.00
30mins
OECD Document 25 has brought in to focus IT security in GLP facilities. Read More.
View pop upNicole Ainsworth, QA Associate, Tower Mains
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.
60mins
This presentation will cover:
- Complexity and challenges of (a)RMMs PV auditing
- Common findings from the audits/inspections and considerations for (a)RMM PV auditing
- Facelift of (a)RMMs PV auditing: What can we do better?
Read More.
View pop upNatasa Mihajlovic, Managing Partner, NostraPharma Ltd
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:
30mins
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? Read More.
View pop upJulie Walker, Consultant QP, JW Quality Consulting Ltd
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.
60mins
This session will present the diverse QA roles and responsibilities within the GxP Quality Assurance field. Read More.
View pop upRobbie Boyle, Senior QA Manager, ZigZag QA
Leanne Scott, QA Supervisor, Charles River Laboratories
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.
12.30
30mins
This session redefines the role of QA during operational crises, moving beyond traditional problem-spotting to emphasise collaboration and strengthening organisational processes. By focusing on solutions and driving improvements, it highlights how crises can become opportunities to optimise quality systems and showcase QAâs strategic value within the organisation. Read More.
View pop upFrancesca Drake, Quality Consultant, Headway Quality Evolution
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.
13.00
60mins
Use this time your way: relax, network, or join a discussion
14.00
30mins
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. Read More.
View pop upMaxim Bunimovich, Director, The QARP
Oleg Shevaldyshev, The QARP, Director, Quality & Compliance
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.
30mins
Inspections around the world are becoming more frequent and new inspectorates are coming on stream. This presentation aims to give you an overview of how, when and where GVP requirements are reviewed. Read More.
View pop upAndrew Cooper, Pharmacovigilance QA Director, GlaxoSmithKline
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.
60mins
Pamala will present on Operational Challenges and Emerging Trends in Quality Assurance, with a dual focus on key areas. Read More.
View pop upPamela Bobbitt, Vice President of Industry Solutions, Ideagen
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.
60mins
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. Read More.
View pop upFrancesca Drake, Quality Consultant, Headway Quality Evolution
Thomas Stevenson, Quality Consultant, Headway Quality Evolution
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.
14.30
30mins
Training on quality is a challenge for companies. What are the challenges and what else can be done? In this interactive session, let's discuss current training practices and what else could be done. Read More.
View pop upStephanie Martin, Managing Director, SMPV Limited
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.
15.00
60mins
Use this time your way: relax, network, or join a discussion
16.00
30mins
Anna will discuss the approach to quality assurance itself. Are we, as QA professionals, supporting the result or the process? Are we changing, becoming digital and flexible, or are we sticking to the 'good old classic' which is sometimes too formal and does not improve the result?
View pop upAnna Petrovskaya, QA Director, Flex Databases
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.
60mins
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...Read More.
View pop upDenise Lacey, Developer, Ready Room
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.
30mins
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. Read More.
View pop upCara Williams, Lead Consultant/Owner, Pragma GCP Consulting
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..!
60mins
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? Read More.
View pop upJohn Cheshire, CSV Consultant, Headway Quality Evolution
Christine Mitchell, Consultant, ChrisalisQAdvice
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.
16.30
30mins
This presentation is about the challenges and solutions to long-term data quality when retaining and archiving GxP data. Read More.
View pop upMatthew Addis, CTO, Arkivum
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.
30mins
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. Read More.
View pop upSuzanne Fowler, Project Manager, Deciphex
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.
17.00
60mins
Our popular Question Time session - this time focusing on any questions from the day.
Use Slido to anonymously post and answer questions set by the rest of the attendees. Run by the RQA office. Speakers have also been invited to attend.
Come for the questions - stay for the answers!
08.00
30mins
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. Read More.
View pop upJayaganesan Thiyagarajan, Business Architecture Manager (Q&C Manager), Accenture
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.
60mins
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. Read More.
View pop upMax Feltham, Head of Quality Assurance, Image Analysis Group
Alia Hussain, -, Amgen
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.
30mins
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. Read More.
View pop upHanna Preus, Executive Director, Quality and Compliance, TFS Health Science
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.
08.30
30mins
With tectonic shifts in the regulatory landscape, we're seemingly constantly assessing and re-assessing our processes and systems in line with the updates in expectations. This presentation aims to highlight some of the tools and methods that can be utilised to perform these assessments effectively.
Patricia Henley, Associate Director, GD Quality Management (GCP), Regeneron Pharmaceuticals Inc
Piran Sucindran, Head of Quality and Regulatory, Blue Earth Therapeutics
30mins
The recently released ICH E6 R3 raises numerous questions for Pharma, CRO, and Supplier companies regarding compliance with the new expectations. We can help clarify how these changes impact the software environment supporting Clinical Research and outline the necessary actions to ensure compliance. Read More.
View pop upLaszlo Mindak, Solutions Architect, Simploud Ltd.
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.
09.00
60mins
Use this time your way: relax, network, or join a discussion
10.00
60mins
Your mission, should you choose to accept it, is to master the three critical elements of vendor management in clinical trials. Read More.
View pop upTom Lazenby, Founder, Mayet
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
30mins
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. Read More.
View pop upHans de Raad, CEO, OpenNovations
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.
30mins
In the world of Quality Assurance (QA), conflicts often arise due to differing perspectives, high-pressure environments, and the complex nature of regulatory compliance. Read More.
View pop upSanil Kumar, Asso.Vice President, Accenture Solutions Pvt Ltd
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.
10.30
30mins
By leveraging tools such as machine learning, natural language processing, and predictive analytics AI enhances key audit functions including risk assessment, audit planning, and compliance tracking, ensuring more efficient, accurate, and data-driven audits. Read More.
View pop upJanki Soni, Lead/Senior Principal, Clinical & Medical Quality, Alvotech
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.
30mins
As clinical trials grow in complexity, risk-based quality management (RBQM) is no longer optional. It is essential. Read More.
View pop upLeire Zuniga, Chief Quality Officer, Qlarix Healthcare Solutions
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.
11.00
60mins
Use this time your way: relax, network, or join a discussion
12.00
30mins
What is Gen AI?
What can it be used for in pharma ?
If used for GxP purposes how we demonstrate that it is fit for purpose.
The additional risks and mitigations that Gen AI brings.
Joanne Donald, Principal Computerized Systems Process Portfolio Lead, Roche Products LTD
60mins
Companies all over the world are eager to use AI. But how can it be achieved to get everybody on board and accomplish AI implementation overcoming different challenges? This presentation shows the critical points to consider.
Marina Kemmerer, Associate Director, Otsuka Pharma GmbH
60mins
A reminder of SB requirements globally, highlighting any new requirements / changes. Read More.
View pop upSamantha Wade, Snr Director, Quality and Compliance, ICON Clinical Research (UK) Ltd
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.
12.30
30mins
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. Read More.
View pop upPaula Walker, Global Head of RBQM, Roche
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.
13.00
60mins
Use this time your way: relax, network, or join a discussion
14.00
30mins
The most common model of risk management used in the pharmaceutical industry has some real issues. Multiplying a number between 1 and 5 with another number between 1 and 5 isn't helping as much as we might like. If everything we are doing contains elements of risk, do we ever do anything that isn't risk management?
Daniel Bennett, Senior Quality Consultant, RiverArk Limited
60mins
This presentation will show the current state of the global laws, including but not limited to the AI Act...Read More.
View pop upNikodem Latocha, Associate Director - Computerized Systems Quality, Primevigilance
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.
60mins
An opportunity to discuss hot topics in GCP with the RQA GCP Committee. Read More.
View pop upPiran Sucindran, Head of Quality and Regulatory, Blue Earth Therapeutics
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.
14.30
30mins
The Integrated Risk Management Solution (IRMS) revolutionises GCP risk management by fostering cross-functional collaboration and connecting risks at various levels. Read More.
View pop upTarin McTague, Sr. Director, Sr. Risk Management Lead, Pfizer
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.
15.00
60mins
Use this time your way: relax, network, or join a discussion
16.00
60mins
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. Read More.
View pop upWumi McDowall, Head of Regulatory Quality, Seqirus
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.
60mins
Integrating Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) is essential for regulatory compliance and patient safety. This talk will cover how GCP and GVP overlap, especially during audits. We 'will discuss shared responsibilities in clinical trials and post-marketing, common audit findings, and ways to streamline audit planning and their execution. Attendees will learn how to improve audit processes, encourage teamwork between GCP and GVP teams, and ensure thorough oversight for regulatory and patient safety goals. Read More.
View pop upJana Hyankova, Head of PV Department, IVIGEE Services a.s.
Dounia Sbai, Head of R&D Quality Assurance Audit Division, Servier
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.
30mins
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. Read More.
View pop upDaniel Bennett, Senior Quality Consultant, RiverArk Limited
Milind Nadgouda, Director, RiverArk Limited
Kim Ritchie, Senior QA Auditor, RiverArk Limited
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.
16.30
30mins
The focus of our session will be on why automation is a more reliable, compliance-driven solution compared to AI in regulated environments. Read More.
View pop upGraeme Ladds, Director, PharSafer Associates Ltd
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.
17.00
60mins
Our popular Question Time session - this time focusing on any questions from the day.
Use Slido to anonymously post and answer questions set by the rest of the attendees. Run by the RQA office. Speakers have also been invited to attend.
Come for the questions - stay for the answers!