Programme

Ensuring Patient Safety with Future Pharmacovigilance Challenges

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.

Stay Ahead: Anticipating Clinical Trials Risks with RBQM

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.

Digital Health Technologies and Their Impact on Clinical Trials

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.

The Only Man who Never Makes a Mistake is the One who Never Does Anything

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.

Beyond Reading and Understanding: Bloom's Taxonomy for Training Objectives

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?

Unlocking Risk Proportionality through Cross-Functional Critical Thinking

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

Using Generative AI in Assessing the Impact of Regulation Changes on SOP Landscape

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.

Sponsor Session - DQA

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.

Beyond the Band-aid: Root Cause Journey to Strengthen the Effectiveness of CAPAs

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.

Innovating Compliance Training: Impactful Learning Strategies for the Digital Age

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.

GLP and GCP Compliance post a cyber-attack? A real experience based on risk management

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.

Clinical Sites and Sponsor's Responsibilities when using Electronic Systems

The workshop will cover topics such as

• What are the PI responsibilities towards data integrity in systems and maintenance of chain of custody?
• How to keep adequate vendor oversight, conduct of remote audits,  using risk base approach and remain compliant with the regulatory requirements.
• Data Integrity and Security: ensuring the integrity of data is crucial. This involves maintaining accurate and complete records, preventing unauthorised access, and safeguarding against data loss or corruption.Implementing security measures to protect sensitive information is also essential. This includes user management, access controls, and encryption.
• Validation and Compliance: validating computerised systems ensures that they function correctly and meet their intended purpose. This involves testing, documentation, and adherence to regulatory requirements. Compliance with legal and regulatory standards is vital. Systems used in clinical trials, for example, must adhere to the guidelines.
• System Design and Development: selection of components, ensure designs meet specifications. Issue reports summarising critical information.

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.

Keeping Pace with Change: Scrutinising Recent Legislative Updates in Data governance, AI and Cybersecurity

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.

Tackling Issue Resolution and Creation of a Mature Quality Culture

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.

Quality by Design - in principle and in practice

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).

How Training Practices Drive Competence

• Are you in Research and struggling to relate the GXP training you receive to everyday activities?
• Does taking a risk-based approach mean you look at everything as quickly as you can without understanding the checklist you’re asked to complete?
• Are you ever faced with training materials designed for someone, but it’s not you in your role?

If 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.

Risk Based Approach to Quality Assurance: Future Proofing QA

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.

Implementation of PV-QMS in Japan

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.

Let Data Analytics Be Your Guide: Elevate Your Auditing Journey

During the presentation I will discuss some of the ways in which data analytics can be used to elevate the auditing process such as:

• Selecting areas for audit 

• Detecting issues during audits

• Predicting and mitigating future issues.

GCP Audits of Computerised Systems: The Final Frontier?

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.

Foundations in the Future-How Emotional Intelligence and Soft Skills Promote the Human Aspect of Quality in an Increasingly Digital World

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.

Risk Proportionality Through Critical Thinking: Using it Best to Focus on what Matters Most

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 ?

Practical Ways to Evaluate Training Effectiveness (Are We Nearly There Yet?)

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.

Clinical Trial Digital Data and eData flow

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.

Third-party Qualification Assessments for fraud prevention

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.

Turning Regulatory Compliance to Performance: Challenges of Data and How to Harness it Effectively

Building 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.

Unlocking the Potential: Leveraging AI, ML, and NLP to Enhance Health Sciences Data Management

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.

Let's Discuss Current DCT from a QA Perspective

A panel discussion between speakers from Japan, Europe and the UK.

• In this session, we would like to share information and discuss the situation and issues in various countries regarding DCT implementation and reliability assurance.
• Discussions of DCT in Japan began around 2018 and have become more active with the pandemic and the introduction of the concept of Patient and Public Involvement. However, the number of clinical trials applying the DCT concept in Japan is very limited now.
• The JSQA study group, have conducted research on applicable regulatory requirements, issues, and measurements from the perspective of quality assurance and compiled as a checklist from the point of view of items to consider when auditing/receiving an audit of the study applied DCT solutions.

Cell and Gene Therapy - Constructing Quality Around the Patient Journey

• The fast-evolving cell and gene therapy landscape
• Sharing interactive experiences of challenges to ensure quality around patient journey
• Navigating the complexity of the regulatory environment.

Risk Management in DCTs: Elevating Vendor Oversight with ICH E6(R3)

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(R3) guidelines impact vendor management practices and how to adapt risk management strategies to align with these evolving standards.

Beyond the Checklist: Enhancing Auditor Competence and Judgement in Risk-Based QA Programmes

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.

Transforming Validation Using AI and Automation

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.

Laying the Foundations of Risk Management in a New Generation of Scientists

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.

Future Foundations

An hour dedicated to discussions around what you have learnt today with fellow delegates and speakers.

ICH E6(R3)

Join Rebecca Stanbrook of the ICH E6 R3 Working Group to discuss the latest updates. 

Regulator Session

Join regulators from the MHRA and FDA as they discuss expectations and challenges with Real World Data submitted as Real World Evidence, including a discussion of considerations for inspector access to e-systems during any type of inspection

Keynote Speaker - Cathy Molohan

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.