Keynote Address

Jonathan Van-Tam is a public health specialist with a clinical background in emergency medicine, anaesthesia, and infectious diseases. He is an expert on respiratory viruses and pandemics and is currently Pro Vice-Chancellor, Faculty of Medicine, and Health Sciences, at the University of Nottingham. His career has also taken him to Public Health England, the World Health Organisation, and the pharmaceutical and vaccine industries. Jonathan was seconded to the Department of Health and Social Care as Deputy Chief Medical Officer. He is well-known for his leadership role during the COVID-19 pandemic, particularly his straight, no-nonsense, communication style from the podium at number ten Downing Street, and for the acquisition and rollout of vaccines and antiviral drugs in the UK. After stepping down as Deputy Chief Medical Officer for England he returned to the University of Nottingham as its Pro-Vice-Chancellor for Medicine & Health Sciences. Jonathan received a knighthood from Her Majesty the Queen in her New Year’s Honours List, for services to public health. He has also been awarded the Royal Society’s Attenborough Award and Lecture for outstanding public engagement in science.

Exploring the depths of quality - regulator updates and Q&A

Join Chrissy Cochran, FDA, an MHRA representative and other regulators in this update and delegate Q&A session.

Issue management and SB reporting in the digital world

Are you seeing an increase in more complex issues/non-conformances escalated to QA as a result of changing CT environment and move to DCTs? This session will explore the types of issues being reported from DCTs, how to manage Data Integrity issues and how to assess these issue types for SB reporting. Delegates will come away from the session with a better understanding of the types of DI issues being seen by industry, how to manage these issues and if these need to be assessed for SB reporting.

DCTs and the Evolving Regulatory Acceptance

This session will cover the evolving regulatory landscape governing decentralised trials with a focus on the EMA and FDA Guidance document.

Building the plane as we fly it

It's a challenging time to work in Clinical QA, whether in a start-up conducting its first trial without yet having established procedures in place, or in a larger company managing multiple trials under a QMS in constant need of update. Things are moving quickly. It took 20 years to go from ICH GCP R1 to R2, and less than half that time to go from R2 to R3. Technology is changing. Regulatory requirements are changing. A GCP auditor used to be an expert in GCP; now we have to be experts in GCP, computerised systems, data privacy, and more. Data Integrity used to be based on the 5 ALCOA principles; now it's based on 10 ALCOA++ principles. When QA teams are expected to be reliable resources for clinical development teams, how do we maintain our expertise in all these areas? How do we keep up?

What is Digital Innovation and how can Quality Organisations leverage emerging technologies to support fast changing landscape

• Digital Innovation
• Impact on Quality Organisation (Digital Health initiatives, Decentralised Clinical Trials, Digital Bias, AI/ML and new regulations)
• How BMS RDQ fosters Innovation (Talk about Ideation portal and Innovation Strategy)
• Dive into 2 to 3 use cases that are in the pipeline– AI/ML in Intelligent search on QMS data, BOTS for Audit Prep
• Discuss with Industry peers to get their perspectives and approaches to enable Digital Innovation
• Any challenges and considerations associated with implementation.

Navigating Open Source Software Technologies in GxP Regulated Environments: Key Insights for QA Representatives

This presentation explores the challenges and critical aspects of implementing open source software in GxP regulated environments, focusing on regulatory compliance and application deployment. QA representatives will gain valuable insights and knowledge to navigate the complex landscape of open source software in pharma and medical fields.

Going Off Script: Breaking away from traditional CSV test scripts with alternative risk-based approaches from GAMP 5 2nd Edition and FDA Computer Software Assurance (CSA)

Updates in GAMP 5 2nd Edition and FDA CSA have promoted the use of alternative risk-based CSV test methodologies to maximise efficiency and reduce the CSV burden. These approaches break away from the traditional robust test script and allow Critical Thinking to drive forward a project in lieu of excess documentation and screenshots. This presentation will identify and discuss these alternative testing methods and evaluate the positives and negatives of each.

Maintaining Pharmacovigilance Compliance in an Increasing Complex Regulatory Environment

How do we ensure on-going quality and compliance in a ever changing pharmacovigilance regulatory seas. What are the key challenges? How to navigate them without needing lifeboats.

Regulatory Intelligence oversight

Regulatory intelligence is a critical component on the road to achieve regulatory compliance. The presentation will guide you through process of regulatory intelligence and show how to keep oversight over the regulatory intelligence landscape globally. You will be able to discover efficient way to reliable regulatory intelligence in diverse global world.

No Centre, No Clue? Workshopping Decentralised Trials

The decentralised trial, or DCT for short, is THE current buzzword in clinical research. You probably know what they are, but have you ever designed one from scratch? Well now you can. Attend this workshop and by the end, you will be an expert at designing the critical aspects of a DCT, with insights into how you would then audit them.

ICH-GCP draft updates and potential impact workshop

The changes included in the ICH GCP draft update will have an impact on organisations process and working, our workshop will look at some potential consequences it will have on systems and processes. Our workshop intends to take a holistic view point of all changes occurred in legislations that influence how clinical trials are conducted and delivered in a changing world. We will bring in some key understanding of the changes at the strategic level that may be needed and how these will impact operational deliverables for maintaining compliance.

What does a Learner-Centric Experience look like in a GxP world? Workshop

This workshop will explore the topic of how we can take a more learner-centric, learner-friendly approach to the way we manage learning, that ultimately results in compliance that counts. People who are competent, confident and qualified - and doing the right things in the real world.

Diversity within Sciences

A panel discovery session - covering topics such as - lack of representation, what else do you expect diversity to happen?

GLP QA Clinic

The GLP MA have found is there are still issues with Test Item Characterisation, delegates will be presented with scenarios for discussion. A panel, made up of the MHRA (Michael McGuinness), Industry (CROs/sponsors), and consultants, will feed back their viewpoints. Following this, delegates will discuss certain topics within their tables, with 15-20 minutes at the end of the session for open questions for the MHRA.

IT QA Clinic

Overview of key aspects (by Nicola Stevens) and a round-table discussion of IT best practices

Detecting and Preventing Fraud and Misconduct in a Virtual World

The pandemic led to changes throughout the world of clinical trials, and none more noticeable than the rise of all things virtual and remote. Technology has played a key role in our ability to conduct trials from afar, which has unfortunately led to changes from ‘traditional’ research misconduct to new digital delinquency. Quality needs to catch up with these nefarious behaviours, adapting how we detect and handle potential fraud and misconduct. This presentation will cover key areas for Quality to consider when detecting and preventing fraud and misconduct in a virtual world.

Serious Breaches - new European requirements

Regulation (EU) No 536/2014 requires the management of serious breaches of clinical trials authorised in the Europe Union (EU)/ European Economic Area (EEA). This is a new requirement for many EU/Non-EU sponsors and reporting of breaches may be delayed or missed. Even sponsors in the UK with awareness of the principles due to MHRA requirements are surprised about some changes. This presentation will define the new requirements and challenges the conference participants to re-evaluate their Serious Breach processes.

Risk based process auditing approach

The journey of risk-based process auditing, exploring challenges and the lessons learned, from an idea to a practical approach.

PMDA and sponsor GLP inspection conducted in Japan under the pandemic

Results of the survey on "remote inspection" for GLP test facilities in Japan. Matters of concern on taking remote audits. Recent progress on GLP operation in Japan due to collaboration with regulatory authorities, new GLP notifications and research activities for JSQA GLP division.

Computer System Validation (CSV) and CyberSecurity Throughout Technology Lifecycle (Panel)

Discussion of CSV throughout technology lifecycle, from the technology development and adoption to decommissioning and long-term archiving use. The focus is on cybersecurity rules and regulations applicable to the software development and deployment, and IT care during operations and long-term data integrity.

AI How to Validate it for GxP Purposes in real life

An overview of how to validate AI GxP Computer Systems. This will cover the new additional AI deliverables required, for example the Data Acquisition Plan. It will cover some case studies of how to validate AI systems in real life.

AI How to Validate it for GxP Purposes in real life

An overview of how to validate AI GxP Computer Systems. This will cover the new additional AI Deliverables required like for example the Data Acquisition Plan. It will cover some Case Studies of how to validate AI systems in real life.

Japanese Pharmacovigilance Audit Activity - New Tide of Quality Assurance

The current status of pharmacovigilance audit activity in Japanese pharmaceutical companies will be introduced. 1) Japanese PV auditing follows EU-GVP Module IV and is generally conducted in the same way. 2) There are several challenges of Japanese PV auditing that need further discussion. 3) A survey for JSQA member companies shows that the implementation of the PV-QMS and PV auditing is still in a development status in Japan.

ICH E8 R1: The Renovation of GCP - A Framework to Support Clinical Trial Implementation

ICH’s renovation of Good Clinical Practice (GCP) updates the overarching guideline E8, General Considerations for Clinical Studies, and the operational guideline E6, Good Clinical Practice. The updates represent a philosophical shift in the conduct of clinical research and development from a one-size-fits-all approach to promoting a proactive, pragmatic, risk-based approach. For some in the industry the renovation has seismic impact; moving away from the traditional linear approach of conducting clinical research activities, towards a multi-disciplinary, proportionate approach focusing on what matters.

• A successful risk-based culture places knowledge at its centre:
• Values and rewards the collection, assessment and assimilation of new data and information;
• Utilises a culture of critical thinking and challenging the status quo;
• Prioritises stakeholder engagement;
• Supports diversity and inclusion within clinical studies.

The TransCelerate framework focuses on the elements identified as essential for successful implementation for ICH E8 as the foundation for the revisions to ICH E6. This session will demonstrate the change of perspective and potential ways of implementing the GCP renovation, focusing on key components in two categories:

• Designing Quality into Clinical Studies - focusing on the elements of Quality by Design and Critical to Quality Factors.
• Culture and Engagement - how a culture of quality and a growth mindset drives compliance and innovation and how involving stakeholders increases diversity and inclusion in clinical study participation.

Exploring the globe or stuck in the mud: ensuring your QMS vehicle is best positioned to reach its quality destination

Throughout history, modes of transport have been continuously designed and adapted to best suit the landscape ahead and safely get the passengers to their destination. A similar history can be seen with clinical trial quality systems, and the same design principles can be applied to them to cope with an increasingly changing landscape, and to enable us to explore further with research while still protecting our passengers.

Communication Skills of an Auditor Workshop

While technical expertise and knowledge of the regulatory requirements are essential for auditors, effectively communicating with management and auditees to effect change and improvements is key. This interactive workshop will look to develop these skills.

The Consultant's Life - exploring the 90% below the surface

A panel session to explore the hidden facets of life as a consultant. A session for existing consultants to share experiences and for those thinking about moving into consultancy to understand more in depth what the life involves.

Taking the Hyperbole Out of AI

Everyone’s heard about the enormous potential of artificial intelligence (AI). When we think about what it might mean for life sciences, there’s a lot of excitement, but also plenty of room for speculation and worry. There’s no room for unknowns in regulated industries, and AI presents plenty of unknowns. However, there are some use cases that we can confidently use, both in terms of being compliant and achieving positive outcomes with minimal risk. The key is to focus on areas where the power of AI can supplement human reasoning and wisdom in an understandable way. In this session, we’ll be covering some of the exciting future-facing impacts AI might have on quality management in the life sciences, what practical realities you should keep in mind as you contemplate usage, and what the path forward to achieving value from AI might look like for a quality manager. Key takeaways from this session include: • Understanding how to evaluate risk related to utilising AI. • The importance of human involvement. • Identifying safe, compliant, and practical use cases that are impactful for quality management today.

Harnessing the power of open source and open standards through the use case of Aranei and SonadorAI

In this session, we will explore the integration of OpenNovations Aranei, an open source data management platform (DMP), and SonadorAI, an open source medical imaging platform, to create AI-driven solutions that address complex clinical and scientific challenges. The collaboration of these two platforms offers healthcare providers unparalleled insights into their data, allowing for more accurate diagnoses, enhanced confidence, and increased efficiency within the clinic.

How can we embed Data Analytics capabilities within Drug Development Quality? Workshop

Workshop to discuss various aspects of how we could build and embed data analytics, critical thinking and related capabilities within Quality Assurance to pivot towards a new way of operating in the assessment of risk and generation of QA evidence.

Training and performance where is the missing link? Workshop

Training and performance where is the missing link? This presentation will: provide an overview on the current issues related to training efficiency, present a few case studies how the training efficiency could be improved in GCP regulated activities, propose a strategy for continuous training efficiency based on the management commitment to quality and quality culture

Risk Management from an audit perspective

Tracking, traceability and audit/inspection ready. Partnering with quality to break barriers and develop a successful relationship

Left out in the cold - deep dive on supply chain disruption and potential mitigation

This presentation will look at business continuity and supply chain with a comprehensive understanding of the factors that contribute to supply chain disruptions, as well as proactive measures to reduce risk and increase resilience. Companies can work together to address the underlying issues that contribute to drug shortages and ensure that patients receive the care they need. This will not only benefit patients but also enhance the reputation and sustainability of the pharmaceutical industry.

How Advanced Quality Event Management Optimises Resources and Saves Your Bottom Line

Quality professionals can use standardised quality event management (QEM) processes to reliably route and resolve quality events before it's too late. A digital quality management solution with advanced process capabilities is a great tool that can go beyond quality management and help organisations reduce and mitigate risk in other functional areas, including clinical operations.

Breaking the status-quo: an effective approach for supplier management in clinical research

This presentation will: provide an overview on risk-based approach for initial suppliers assessment, provide a strategy for determination of metrics for ongoing performance evaluation and provide a strategy for data-driven changes in risk-indicators.

Why don't they do what we ask them to do?! The human factor in quality improvement

Even though you feel that your organisation has a robust quality management system and the cleverest teams and managers in the industry, you still see the same issues popping up (or actually, not being escalated to the quality department!). The power of habits is strong, so can we ever change that? This presentation will focus on the human factor in quality improvement by looking at opportunities to apply a behaviour change model, with techniques based on elements of social psychology, in breaking habits that affect the quality and compliance in an organisation and/or are demotivating teams.

QRM and Quality - Making sure fear doesn't undermine your QRM programme

This presentation will explore the purpose of QRM and how this often gets undermined due to lack of knowledge and fear of letting go. Even though we identify the highest risks through our risk assessments, we sometimes also mitigate other perceived risks due to existing bias and perceptions because we think this is the right thing to do and that it is better to be conservative. However, this approach often undermines the whole QRM process and dilutes the priorities for mitigation and improvement.