Programme
The programme isĀ grouped these into six key areas for 2024: Risk Management, Digital Challenges, Foundations in the Future, Managing Deviations and Disasters, Training, and Investigational Product.
The programme isĀ grouped these into six key areas for 2024: Risk Management, Digital Challenges, Foundations in the Future, Managing Deviations and Disasters, Training, and Investigational Product.
08.00
60mins
Join exhibitors and sponsors for tea and coffee in the Exhibition Area.
08.30
15mins
A welcome from our Chair, Tim Stiles and our Platinum Sponsor, Honeywell.
08.45
75mins
A session designed to set your goals for the rest of the conference, run by the 2024 Programme Committee.
10.00
30mins
Join exhibitors and sponsors for tea, coffee and a bite to eat in the Exhibition Area.
10.30
60mins
First Principles of Quality: Rebuilding Foundations for a Data-Driven Future
A keynote presentation by our Platinum Sponsor, Honeywell.
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In a rapidly evolving industry landscape, the quest for excellence in quality management demands a return to foundational principles. This keynote will delve into the concept of "first principles thinking" as the cornerstone for reconstructing quality systems in the life sciences sector. By stripping down complex processes to their most basic elements, we will explore how to rebuild and enhance these processes using the transformative power of data analytics and technology. Attendees will gain insights into practical strategies for leveraging data to drive decision-making, ensure compliance, and foster continuous improvement. Join us to discover how a principled approach can unlock new potentials, setting the stage for a future where quality is not just maintained but continuously redefined.
Fabrizio Maniglio, Industry and Business Development Director, Honeywell
Fabrizio Maniglio is an industry thought leader and the Director of Industry and Business Development for Honeywell. He leverages vast subject matter expertise to drive innovation for the industry and within Honeywell, where he continuously monitors the evolution of the ever-changing healthcare and life-sciences sectors. He fosters contacts with other industry thought leaders and regulators to collaborate and influence the future of our industry.
He contributed five years as an Expert Solutions Engineer with Honeywell - Sparta Systems, deepening his understanding of quality life cycle management and the life science industries. He was a key differentiator in helping customers achieve their quality management goals.
Before Sparta Systems, he served nine years at a leading European-based Contract Manufacturing Organization (CMO) in the Pharma, Biotech, and Specialty ingredients industry. He served in numerous global quality-related roles, spanning Deviations Management, Head of Audit QA and Compliance, and most recently as QA Manager for Data Integrity and Computer Systems Validation in Switzerland, the UK, and China.
As a result, Fabrizio provides a blend of deep industry, QMS, and cutting-edge technical knowledge and is uniquely placed to advise customers and the industry on the future of quality.
11.30
60mins
TBC
Chrissy Cochran, Director, Office of Bioresearch Monitoring Operations, FDA
12.30
60mins
Join exhibitors and sponsors for lunch in the Exhibition Area.
13.30
90mins
AVP Committee Session - Workshop
Sven Buckingham, Director, Buckingham QA Consultancy Ltd
Helen Harlow, Global Quality and Training Director, GXP Engaged Auditing Services
Lindsay Heasman, Director, Hurst Animal Health Ltd
30mins
An update from the GCP Committee.
View pop upRosemarie Corrigan, CEO, GxPQA
Cathy Dove, Director and Owner, Dove Quality Solutions
Join members of the GCP committee as they present changes and challenges with the update to ICH E6 R3.
90mins
GLP Committee Workshop
View pop upCate Ovington, Director, The Knowlogy Group Ltd
An interactive session exploring behaviours of auditor and auditee vendor audit, to agree a standard approach for a successful audit. From preparation, conduct, reporting and responses. This session is directed at those that host or perform external audits and also opportunity to learn more. Run by Cate Ovington and the GLP Committee.
45mins
IT Committee Session.
View pop upJohn Cheshire, CSV Team Lead, Resolian
Applying critical thinking and effective risk management is necessary to ensuring computerised systems are validated and implemented appropriately. Often the phrase 'quality risk management' is used without a clear understanding of how it should be applied.
This presentation will explore what Quality Risk Management really means in the context of IT and CSV.
90mins
TBC
14.00
20mins
ICH E6 R3 Transcelerate Update
View pop upJoin Transcelerate as they present the impact ICH E6 R3 will have on their suite of tools and resources.
14.15
45mins
IT Committee Session
View pop upBarry McManus, Consultancy Partner, Empowerment Quality Engineering Ltd
Organisations are focusing on unscripted testing to reduce effort and using "CSA" as justification. CSA is risk based approach that is not 'just' a reliance on scripted and unscripted testing. Quality process and software product performance monitoring is an activity that has been ignored over time - this talk will reconstruct this activity to justify the scope of (un)scripted testing.
14.20
40mins
QA Clinic
View pop upRosemarie Corrigan, CEO, GxPQA
Cathy Dove, Director and Owner, Dove Quality Solutions
Shaun Hastings, Director of Quality Assurance, PHARMExcel
Share your thoughts, ask questions, get advice from the committee and audience with a focus on ICH E6 R3 changes, challenges and implementation.
15.00
30mins
Join exhibitors and sponsors for tea, coffee and a bite to eat in the Exhibition Area.
15.30
45mins
AVP Committee Session
View pop upNikki Potgieter, Director Quality R&D, AsiaPac, Elanco Animal Health
Panel session.
30mins
GCP Committee Session
View pop upNicholas Connor, Interim Head Research Governance & Integrity, LSHTM
Patricia Henley, Associate Director, GD Quality Management (GCP), Regeneron Pharmaceuticals Inc
Samantha Wade, Snr Director, Quality and Compliance, ICON Clinical Research (UK) Ltd
Join members of the GCP committee who will share their experiences of changes and challenges being faced as a QA professional especially in this 'new' digital world.
90mins
GLP Committee Workshop
View pop upSven Buckingham, Director, Buckingham QA Consultancy Ltd
Peter Connaughton, Senior Director Quality Systems and Technology, AstraZeneca
Michael McGuinness, Head of GLP & Laboratories, MHRA
The 'Quality Reconstructed: Interactive GLP Scenarios and Regulatory Insights' workshop offers an interactive opportunity for delegates to discuss and dissect real-world GLP scenarios, fostering a collaborative learning environment. Participants will gain direct insights from a UK GLP Monitoring Authority representative, enhancing their understanding of regulatory expectations and practical compliance solutions.
45mins
TBC
Hans de Raad, CEO, OpenNovations
Nina Haeuselmann, CEO, Haeuselmann Consulting GmbH
Barry McManus, Consultancy Partner, Empowerment Quality Engineering Ltd
Thanabalan Subramanian, Head of Quality, Integrity
90mins
TBC
16.00
60mins
GCP QA Clinic
View pop upNicholas Connor, Interim Head Research Governance & Integrity, LSHTM
Patricia Henley, Associate Director, GD Quality Management (GCP), Regeneron Pharmaceuticals Inc
Samantha Wade, Snr Director, Quality and Compliance, ICON Clinical Research (UK) Ltd
What is keeping YOU up at night? Is it ICH E6 R3 implementation? Is it AI taking over the QA role? Is it the challenges with building a quality team and upskilling in this ever changing 'new' digital world?
Share your thoughts, ask questions, get advice from the committee and audience on the GCP topics that keep you awake at night!
16.15
45mins
Panel discussion.
Nikki Potgieter, Director Quality R&D, AsiaPac, Elanco Animal Health
45mins
Join representatives from the IT Committee to discuss current hot topics and to ask your questions.
17.00
30mins
A chance to reflect on the day's learning with fellow delegates and speakers.
17.30
90mins
Network with fellow attendees in the Exhibition Area. Alcoholic and Non-alcoholic drinks available.
08.00
75mins
Panel Discussion
View pop upMichael Bean, Senior Director, Regulatory Compliance, Johnson & Johnson
With the ever increasing complexity of science, technology and regulations that will throw up challenges in maintain compliance and patient safety. What can we do to prepare and meets these successfully.
60mins
Join exhibitors and sponsors for tea and coffee in the Exhibition Area.
40mins
Presentation
View pop upLeire Zuniga, Director, Principal GCP Consultant, Qlarix Healthcare Solutions
Clinical Research is advancing quickly, making it essential for sponsors, CROs, and other stakeholders to prioritize proactive risk management strategies. These tactics are essential in order to ensure patient safety, uphold data integrity and reliability, and comply with regulations. Through the use of risk-based quality management (RBQM) systems, clinical trials can detect and address potential problems at an early stage to prevent them from becoming more serious. This change to a more dynamic and proactive strategy represents a major shift away from the traditional, reactive methods.
08.30
45mins
Presentation
View pop upJoshua Marsh, Senior QA Auditor, RiverArk
Kim Ritchie, Senior QA Auditor, RiverArk Limited
Traditionally, clinical trials have relied on data collected during in-person visits, which can be burdensome financially and logistically for patients, especially those with significant morbidity. Digital health technologies have the potential to improve the efficiency and productivity of clinical trials, while also making them more patient-centric. This presentation will delve into the following aspects of digital health technologies: use, positives and challenges and regulatory guidance.
45mins
Presentation
View pop upCoree Forman, Owner, Q-STAR Consulting
Bloom’s Taxonomy describes six levels of thinking, from the lowest level of remembering to the highest, more complex process of creating. Effective training programs set objectives which aim for the higher levels of thinking. How can we implement training tools that go beyond the standard Read & Understand tickbox?
08.40
40mins
Presentation
View pop upPaula Walker, Global Head of RBQM, Roche
Delve into the pivotal role of critical thinking in reshaping the foundation of quality , as demonstrated through the establishment of a Risk-Based Quality Management (RBQM) Center of Excellence (CoE). Learn how the integration of cross-functional perspectives fosters true risk proportionality, prioritizes data reliability over just accuracy, and through this catalyzes product development. Gain invaluable insights from the presenter's dual vantage point as both a CoE builder and a regulator, illuminating the synergies between past regulatory experiences and contemporary quality approaches
09.00
45mins
Presentation
View pop upHenrieke de Bie, Consultant Quality and Cultural Transition, Beyond Compliance
It is natural to experience negative feelings, such as frustration, anxiety or fear, when we have to deal with deviations (mistakes) and failures. But what if we can turn these feelings in an organisation into something a little bit more positive, and we can embrace the concept of deviations and failures as an opportunity to learn, to improve and to innovate?
This presentation provides some suggestions for transitioning the focus on deviations and failures from almost entirely preventive to 'hey, we can also learn from it!', followed by a deeper dive into the psychology behind this change in mindset.
09.15
45mins
Presentation
View pop upRoshan D'Souza, Head of Data Analytics and Operations, Roche
As regulations continue to change and evolve, assessing the impact of these changes on the SOP landscape remains an extensively manual and time-consuming effort. This presentation discusses the use of Large Language Models to help get a head start in this space.
45mins
The Regulatory Blind Spot: Unveiling the Hidden Risks of IT in Healthcare
View pop upMatt Jones, Managing Director, Digital Quality Associates
Within the interface between IT and the pharmaceutical R&D world, there are many grey zones, that if left unexplored or unevaluated can lead to issues and challenges down the line, especially during regulatory inspections. This is compounded by the lean inspection approach, employed by many regulators, looking at the sponsor companies and their oversight of IT suppliers, and not the IT suppliers themselves.
This presentation explores the interface between the sponsor, the IT supplier and eventually the regulator who gives the marketing approval for the sponsor's product.
45mins
Presentation
View pop upNoelle Humphrey, VP of Quality, PrimeVigilance
Milina Petrovic-Milosevic, Director, People Development and Engagement, Ergomed
In the dynamic landscape of compliance training, organizations are pioneering new approaches to drive impactful learning outcomes in the digital age. This abstract unveils a forward-thinking vision, emphasizing the transformative potential of AI integration and just-in-time learning principles to revolutionize compliance training practices and generate tangible business impact.
09.20
40mins
Presentation
View pop upBarbara Vaccarini, Vice President, Head of GLP & Global GCP QA, Aptuit (Verona) Srl, an Evotec Company
With the rise of digitalisation, cyber-attacks have become an emerging risk for GLP and GCP laboratories. This presentation will detail a real-life case study on how compliance was assured following a cyber-attack. Upon discovery of the attack, immediate actions were taken to contain the breach, followed by a structured approach through Business Continuity, Data Recovery, Data Reconciliation, and Impact Assessment phases.
09.45
45mins
Presentation
View pop upTerrina Grove, Senior Director, Quality Management Oversight, Worldwide Clinical Trials
Root cause is the fundamental reason for an issue and is necessary to determine corrective and preventive actions that are solutions rather than band-aids. This session will discuss the journey of root cause analysis to uncover the true underlying cause of issues, avoiding temporary or reactive solutions and focuses on effective corrective and preventive actions for continuous improvement.
10.00
30mins
Join exhibitors and sponsors for tea, coffee and a bite to eat in the Exhibition Area.
10.30
90mins
Workshop
View pop upDounia Sbai, Committee Member, GCP Committee
The workshop will cover topics such as
These responsibilities may vary depending on the specific context and industry. Whether you’re working with electronic clinical outcome assessment (eCOA) systems, interactive response technology (IRT), or other electronic systems, understanding and fulfilling these responsibilities are essential for effective and reliable operation.
45mins
Presentation
View pop upHans de Raad, CEO, OpenNovations
Explore the latest legislative and regulatory changes impacting records management, data governance, and cybersecurity across health sciences in our upcoming presentation. Delve into the implications of the European AI Act, ISO 27001, and the new ISO 42001 on AI and ML applications within GxP-regulated activities. Gain essential insights on navigating these developments to ensure compliance, enhance data integrity, and prepare for future shifts in the health sciences IT landscape.
45mins
Presentation
View pop upSarah Ball, Senior Manager, GLP/GCP Quality Assurance, Labcorp
This presentation will outline an initiative developed by Labcorp that resulted in the launch of a Global Issue Resolution Resource Center. Not only a series of tools but a push to enhance the quality culture of the organisation. We will share how we approached the implementation and how the use of ‘just in time’ training strategies helped to do so over a large scale.
90mins
Workshop
View pop upSameera Ibrahim, Head, R&D Quality Strategy & Business Operations, Bristol Myers Squibb
Jamila Joseph, Senior Director, IQVIA
Workshop to delve into the fundamentals of QbD principles and application to clinical trial execution. Share case studies and best practices from across the industry. Focus will be on how to Operationalise QbD principles to apply a risk proportionate approach recommended by E6(R2,R3) and E8(R1).
90mins
Workshop led by the Research Practice Group (RPG)
View pop upIf you answer Yes to any of these questions our workshop is designed for you. We need your input to design positive coaching and learning experiences.
11.15
45mins
Presentation
View pop upFatemah Jami, Sr.Director, QMS, Worldwide Clinical Trials
Samantha Wade, Snr Director, Quality and Compliance, ICON Clinical Research (UK) Ltd
With more emphasis on risk-based approaches, how should QA adapt to align with risk based clinical trials and how can QA adopt risk-based thinking? This session will aim at answering both questions by focusing on the key skills and knowledge needed to apply risk-based thinking when executing QA activities. We will explore how QA can use risk factors and quality data to change from a ‘reactive’ to a ‘proactive’ approach and how QA can apply critical thinking to ensure we are asking the right questions at the right time. The session will also look at a risk-based approach to non-conformance management, root cause analysis and CAPA development to prevent overburdening our organisations.
45mins
Presentation
View pop upYoshiya Aze, Member, Post-marketing Division, The Japan Society of Quality Assurance (JSQA)
Japanese pharmaceutical companies are working towards implementing a pharmacovigilance quality management system (PV-QMS) within their pharmacovigilance activities to meet global requirements, particularly the EU-GVP guidelines. The Post-Marketing Subcommittee 1 (GVP) of Japan Society of Quality Assurance (JSQA) conducted a study on the challenges and implementation of PV-QMS in Japanese pharmaceutical companies from April 2022 to March 2024. This presentation is based on the deliverables of the study and will provide an overview of the current challenges and implementation status of PV-QMS in Japan.
12.00
60mins
Join exhibitors and sponsors for lunch in the Exhibition Area.
13.00
45mins
Presentation
View pop upPiran Sucindran, Head of Quality and Regulatory, Invicro
As GCP auditors, you're require to wear an ever-increasing number of hats. One of these is to understand computerised systems, how they work, and how they provide assurance from a data integrity and security perspective. In this presentation, we will discuss some key considerations and how you can better assess these in the context of an audit.
45mins
Presentation
View pop upAmy Wotawa, Senior Quality Assurance Manager/Auditor, Zigzag Associates Ltd
In Quality Assurance, and in most other roles involved in scientific research, we naturally place a heavy emphasis on hard skills and technical expertise, but we cannot overlook the significance and impact of soft skills. These soft skills become even more important in the new age of digitization and automation. Emotional Intelligence, or EI, encompasses a spectrum of abilities crucial for navigating the complexity of human interactions and organizational nuances that Quality Assurance professionals face. EI acts as the foundation for many soft skills that keep the human aspect in Quality.
45mins
Panel discussion session
View pop upMichael Smith, Director, Quality Science & Strategy, AstraZeneca
Exploring examples from across the GxPs that shine a light on the best ways to apply critical thinking to defining risk and using it to guide decision-making throughout a project from end to end. Thinking about the level of adoption so far, what could we get better at and why could it matter ?
45mins
Presentation
View pop upIain Searle, Director, Training Strategy, Veeva Systems
Assessing whether training has been successful or not can be challenging and time-consuming. This session will provide an overview of simple, actionable approaches that can be used to evaluate training programs and enhance outcomes.
13.45
45mins
Sponsor Session - Honeywell
View pop upBuilding on the 'First Principles of Quality', this presentation explores how life sciences organisations can transform regulatory compliance from a burden into a performance driver through effective data utilisation. We will examine the challenges posed by the data explosion in the industry—volume, variety, velocity, veracity, and value—and unveil strategies to harness this data for both compliance and innovation. Through real-world case studies and practical frameworks, attendees will gain insights into building a data-driven culture, implementing advanced analytics, and leveraging artificial intelligence to elevate compliance processes.
This session aims to equip leaders with the knowledge and tools to navigate the complex intersection of regulatory requirements, data management, and performance optimisation, ultimately setting a new standard for quality in the life sciences sector.
45mins
Presentation
View pop upRosemarie Corrigan, CEO, GxPQA
Overview of challenges, impact and actions for Clinical Quality at all levels. Clinical Trial eData flow and QA role to ensure quality data and reliable results.
45mins
Presentation
View pop upNaoki Tsutsumi, Professor, Hiroshima University
A whistleblower uncovered fraud by a medium-sized clinical trial Site Management Organization (SMO) in 2023. The SMO went bankrupt and was dismantled without an internal investigation, and no root cause analysis, corrective action, or preventive measures have been taken to address this fraudulent occurrence. The Japanese Association of Site Management Organizations (JASMO) has begun advocating the use of third-party qualification assessments to reconstruct and maintain the reliability and quality of clinical trials.
In response to this effort, an independent consulting firm has developed an SMO qualification program that includes identification of potential fraud causes in addition to a general feasibility assessment and site selection process traditionally conducted by sponsors.In this session, the methods and trends in the findings of third- party qualification assessment, which is used by SMOs to evaluate the support systems of investigational sites and to maintain and improve the quality of their operations.
14.30
30mins
Join exhibitors and sponsors for tea, coffee and a bite to eat in the Exhibition Area.
15.00
45mins
Presentation
View pop upHans de Raad, CEO, OpenNovations
This presentation advocates for the strategic application of AI, ML, and NLP to revolutionize data management in health sciences, enhancing precision in data classification, enriching interoperability, and elevating the overall value of information assets. By dissecting and analysing complex datasets, these technologies can unlock the full potential of (archived, real world, trial, laboratory) data, driving forward medical research and patient care with harmonized and actionable data. The session addresses the future landscape of health sciences data utilisation, emphasising the transition from static storage to a dynamic and fully integrated digital ecosystem.
90mins
Panel Discussion, more panelists tbc
View pop upTerumi Mitsumori, Member, GCP Division, Japan Society of Quality Assurance (JSQA)
Terumi will cover:
45mins
Presentation
View pop upGail Francis, Director, Quality Science and Strategy, AstraZeneca
Victoria Stace, Director, Strategic Advice, AstraZeneca
45mins
Presentation
View pop upTom Lazenby, Founder, Mayet
This session will explore the emerging landscape of risk management in decentralized clinical trials (DCTs) with a particular emphasis on vendor oversight. Attendees will gain insights into how the new ICH E6 GCP Revision 3 (R3) guidelines impact vendor management practices and how to adapt risk management strategies to align with these evolving standards.
90mins
Workshop
View pop upFrancesca Drake, Quality Consultant, Headway Quality Evolution
This workshop delves into the practical application and strategic implementation of audit checklists within quality assurance programs. Through interactive activities and case studies, attendees will learn to integrate checklists effectively both in training and audit processes, while prioritizing auditor judgement skills. The session aims to equip participants with tools to ensure checklists enhance audit effectiveness without stifling innovation.
15.45
45mins
Presentation
View pop upPrem Iyangar, Business and Integration Arch. Associate Director, Accenture
Usage of automation and AI can allow organization to streamline and optimize the validation of systems, processes and take a data centric approach to validation. This transformative approach enhances decision-making, enhances quality assurance, and enables organizations to adapt quickly to changing regulatory requirements.
45mins
Presentation
View pop upFiona Booth, Data Integrity and Quality Assurance Programme Director, University of Bristol
Risk proportionate approaches to quality management and reduction of critical quality issues are key tools for the pharmaceutical professional. At the University of Bristol we are piloting a unique programme to embed these principles in our post-graduate researchers, improving their academic research outputs and embedding the skill set in a new generation of scientists.
16.30
An hour dedicated to discussions around what you have learnt today with fellow delegates and speakers.
300mins
Join us for an unforgettable evening at our Vegas themed dinner dance.
Step into the dazzling world of Las Vegas right here in Brighton, where the magic of the strip meets the elegance of the Oxford Ballroom. Enjoy a night filled with lively music and exciting entertainment that will keep you on your feet all night long.
Don't miss out on the chance to create lasting memories with friends and colleagues in an atmosphere of fun and festivity. Whether you're here to dance the night away or simply enjoy the vibrant company, this is one event you won't want to miss.
Come for the food, stay for the fun, and leave with unforgettable experiences. Dress to impress in 'Vegas Glitz' and get ready to roll the dice on a night of pure enjoyment!
08.30
30mins
Join exhibitors and sponsors for tea and coffee in the Exhibition Area.
09.00
90mins
Panel Discussion
Chrissy Cochran, Director, Office of Bioresearch Monitoring Operations, FDA
10.30
30mins
Join exhibitors and sponsors for tea, coffee and a bite to eat in the Exhibition Area.
11.00
90mins
A major highlight of the conference is our Keynote Speaker and this year we are pleased to announce that Cathy Molohan will be joining us for the final session.
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Cathy is a passionate Parkinson's advocate who embodies the patient-centric mission that drives our work. Cathy’s journey with Parkinson's disease highlights the real-life impact of your research and innovation.
Hear about how Cathy's experiences, from the challenges of daily life to the transformative effects of treatments like deep brain stimulation, underscore the importance of our industry's collective efforts, showing the human aspect behind the science.