Conference Programme
Wednesday 28th – Friday 30th September
Holiday Inn, Manchester City Centre
Wednesday 28th September
Presented by: Dora Endreffy & Russell Joyce
This interactive workshop will look at the challenges and opportunities presented by digitisation and provide practical guidance to those responsible for the management of electronic records and data within their organisation, including the management of:
- records in regulated business systems (such as eTMF and SharePoint sites);
- record lifecycles, including workflow and permissions;
- digital archives
The session will cover a wide range of aspects related specifically to electronic records including:
- regulatory and legal requirements;
- file formats and storage media;
- electronic mail;
- electronic signatures; and
- an introduction to digital preservation.
Presented by: Jamie Toth & Hobson Lopes
While eTMF systems advance, the maintenance of data integrity and management of long-term records become more complex. With rapidly changing regulations, now is the time to join industry experts, Jamie Toth, Beigene and Hobson Lopes, Regeneron, and dive into an in-depth exploration of what record management and regulatory frameworks are required for long-term archiving to ensure a healthy and compliant eTMF:
- Understanding records management principles to ensure a healthy eTMF
- Outlining regulatory framework for GxP archives to best navigate requirements
- Illuminating key required roles for archiving and document management
- Exploring the GxP archive to understand what it involves
- Navigating the use of third parties
Thursday 29th September
AGM
The Annual General Meeting of the Health Sciences Records and Archives Association (HSRAA) will take place at the start of HSRAA22.
How Definition Drift Damages Data
Presented by: Dr Clare Craig, Co-Chair HART group
The value of data is derived from how categories are defined. In the absence of unambiguous standard operating procedures and meaningful definitions that remain stable over time, comparisons cannot be made and data may prove unreliable, lack credibility, and be subject to misinterpretation and misrepresentation. In this presentation, Dr Clare Craig will examine the importance of ensuring the value and integrity of data and documents so that they can be used to:
– make meaningful diagnoses
– confirm the validity of research
– enable evaluation of the conduct of a trial and the quality of the data produced
Break | 10:00-10:30
Artificial Intelligence, Big Data, Deep Learning – What is it and what do record managers need to consider?
Presented by: Anita Paul, Roche Group
We are reading and hearing the terms “Articifical Intelligence”, “Big Data”, “Deep Learning” not only in our professional, but also in our daily lifes. But do we all know what the terms mean and what stands behind them? What are the potential threads and what are the opportunities for society? What should we be aware of as record managers and information governance professionals? What is the relation of e-records and big data pools? How to deal with data privacy requirements in “Big Data”?
This presentation will provide an overview of the underlying technological concepts and techniques.
Driving Content Intelligence – Curing Information Headaches
Presented by: David Gould, EncompaaS
In this talk, David Gould, Chief Customer Officer for EncompaaS will first address conceptual hurdles that currently exist in the records and information management organisations within the pharmaceutical enterprise. With many organisations not “trusting” the use of AI, David will discuss barriers preventing widespread adoption of these new technologies, especially as existing manual processes are proven no longer capable of effectively managing the connection between records and business performance.
David will accentuate his talk with a case study on how one of the world’s largest pharmaceutical companies is adopting AI technology to manage rebates at scale with high degrees of accuracy. Today’s processes to achieve business ambitions are highly manual, extremely complex and fraught with regulatory risk and David will outline how records and information managers are successfully adopting machine learning and other cognition technologies to automate, manage and report on major business processes.
Lunch | 12:00-13:00
Long Term Data Integrity: how digital preservation can help achieve regulatory compliance
Presented by: Matthew Addis, Arkivum
Organisations are required to ensure that data integrity is maintained when archiving GxP data. This includes ensuring that this data remains complete, enduring, available and legible over decade long timescales as embodied in the ALCOA principles. This is the realm of digital preservation. However, putting digital preservation into practice can be challenging. What is digital preservation? Where do I start? What is good practice? How can my organisation assess whether we are doing a good job? Does my approach match the risks, benefits and regulations? Thankfully, the digital preservation community has addressed these questions by developing several assessment and maturity models. This talk will review some of these, for example the NDSA levels of preservation, the DPC RAM and CoreTrustSeal – including how they can be mapped to regulatory requirements and the need for long-term data integrity of GxP data. This enables organisations to get started on a digital preservation journey, provide evidence of good practice to inspectors, and progress digital preservation in a managed and measurable way.
Moving to a Digital Landscape – bringing auditors along with us on the journey
Presented by: David Thompson, Clarity Compliance Solutions
The Digital Landscape is now a commonly used term and many regulated organisations are moving in this direction. Within these organisations there are challenges to understand, implement and move towards a digital landscape.
In addition to the internal challenges there are the external challenges of auditing in areas such as:-
• Internal Audit Team – what do we look for in our customers
• Customer Auditors – what might our customers look for
• Regulatory Auditors – what will the authorities look for
This presentation will explore the challenges, propose ways to approach and present real life example challenges from current ongoing projects and programs
Break | 14:30-15:00
The intersection of information Management and Cybersecurity – Opportunities for Synergy
Presented by: Stan Konopka, VP Information Technology
In this presentation, Stan will use case studies to examine a wide range technological opportunities and challenges related to security issues in the development and implementation of systems used for records and data management information security, hybrid working, data strategy, and cloud transformation.
Think Tank
Lead by: Chris Jones, Novartis
Panelists: Eldin Rammell, Phlexglobal | Stan Konopka, Avacta Group | David Thompson, Clarity Compliance Solutions | Neil Gow, UCB Pharma
Can the panelists change your opinion? Four questions are asked to the audience and their opinions are collected through anonymous voting. These questions are then discussed by the panel who share their opinions and thoughts. After the discussion and audience Q&As the same questions are put to the audience to vote again. Have opinions changed?
Drinks Reception & Conference Dinner sponsored by PhlexGlobal | 19:00-23:00
Friday 30th September
Data Integrity Risk – it’s not as complicated as you think
Presented by: Dora Endreffy, Marken
Following the footsteps of Bob McDowall’s Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories, we will explore why data integrity risk management isn’t a mirage we can never reach, but is the result of a serious of logical steps and decisions.
A Risk-based Approach to Records Management: How Much Risk is Too Much?
Presented by: Eldin Rammell, Phlexglobal
This facilitated round-table discussion will explore the concept of a risk-based approach to drug development activities to identify some practical applications for records management and archiving. Is the “gold standard” required in all circumstances? How much QC is enough QC? Can corners be cut? These questions – and more – will be addressed in this interactive session.
Break | 10:30-11:00
New EU Medical Device Regulations – Operational and Regulatory Compliance Considerations
Presented by: Stuart McCully, Phoenix RWR
Recent changes to regulations in Europe have led to considerable and dynamic changes associated with the implementation of EU 2017/745 (MDR) and 2017/746 (IVDR) regulations for medical devices and in vitro diagnostics, respectively. Both regulations significantly increase the importance of collecting robust and good quality clinical data.
The session will cover a wide range of topics, including:
• Why now?
• EU MDR and EU IVDR regulatory pathways
• Considerations for post-approval studies
• GCP applicability and compliance
• Clinical evidence documentation and retention requirements
Information Asset Management – A Methodology
Presented by: Reynold Leming, Informu Solutions Ltd
This session looks at what Information Asset Management is as a business discipline and why it is needed. It will cover:
– The multi-faceted value of information
– The roles and responsibilities required, including those of Information Asset Owners and Administrators
– The maintenance of an information inventory, including emerging requirements within the Data Protection and Digital Information Bill
– What an information asset actually is
– Key practices for protecting and leveraging the value of assets
Lunch | 12:30-13:30
Objectivity in Science
Presented by: David Charalambous, Reaching People
Can we be objective?
How important is understanding our biases to our thinking and behaviour?
Can our biases be used to influence our beliefs and thinking?
We will review these and how they apply to scientific reasoning, especially in relation to discoveries from behavioural sciences.
Data Chains of Custody – looking back… and then beyond for impact
Presented by: Brenda Phillips, University of Leeds
With a focus on the myriad of university stakeholders managing dependencies that determine primary and secondary research data use and reuse for impact, this presentation will explore perspectives on the differing and detailed data management workflows involved in the academic data chains of custody necessary for research conducted on human participants.
How to Craft Effective Policies and Standard Operating Procedures
Presented by: Russell Joyce, Heath Barrowcliff Consulting Ltd
Poorly written and inconsistently followed policies and standard operating procedures are frequently at the core of observations and findings in regulatory inspections and may lead to an array of other operational and compliance issues.
In this session, we’ll examine best methods for crafting robust policies and procedures that provide unambiguous instruction and are designed to be readily understood and followed, which is critical for ensuring a systematic, consistent and efficient working practices that facilitate regulatory compliance.
Chairman’s Closing Remarks / Summary