Preconference Workshops | Tuesday, 1 October 2019
Registration Begins and Continental Breakfast
Inspection Trends Workshop: Prepare for an Inspection by Understanding Trends, Lessons Learned, and Regulatory Changes

Knowing what to expect when you are inspected is not only difficult, but also one of the most important predictions you could make. So many aspects depend on it and yet there are so many variables that can’t be known. In this workshop, trends will be revealed so that you can better prepare your TMF, your TMF stakeholders, and yourself.

Uncover inspection trends around the globe. Participants from companies of disparate types, sizes, and partnership models will learn how others have (and have not) prepared for and coped with for the inspector’s visit.

Through structured networking, a crowdsourcing exercise and presentations, participants will discuss and share their experiences, ranging from survival stories to triumphs.

  • Compare and contrast lessons learned from inspections from different regulatory authorities
  • Discuss a recent first-of-its-kind joint inspection by the MHRA and the FDA
  • Glean the MOST up-to-date inspection trends and identify common pain points and noncompliances
  • Garner peer and expert analyses and strategies for preparing staff for your next inspection
  • Analyse and use regulatory trends data to improve vendor selection and oversight
Dr. Andrew Bentley, Quality Assurance Manager, MINA THERAPEUTICS
Jane Bushell, Associate Director, Clinical QA, EISAI
Barbara Hepworth-Jones, Director, Clinical Development Regulations and Advocacy, GLAXOSMITHKLINE
Networking Luncheon
TMF Content Workshop: Manage TMF Content in the Complex Regulatory Framework of GCP, Information Governance, Privacy and Ethics

Establishing, maintaining and managing the TMF requires more than a knowledge of TMF requirements contained in Good Clinical Practice. We operate in a complex regulatory environment that includes seemingly conflicting requirements. On the one hand we have subject informed content and consent to process personal data, but on the other hand a need to preserve data integrity and completeness of our clinical data. What measures should we be adopting to ensure our document management systems and processes are efficient, effective and streamlined and yet we follow ethical business practices and protect the rights of data subjects? And how does good information governance help? This half-day interactive workshop will explore these challenges using real-life scenarios, supported by an in-depth review of the applicable legal and regulatory requirements.

  • Review of regulations in the context of TMF management, including HIPAA, GDPR, Declaration of Helsinki
  • Interactive group work, assessing challenging scenarios for data privacy, information governance, and data integrity
  • Garner recommendations for workplace actions that improve the efficiency of your document management systems

*Includes one 30-minute break.

Eldin Rammell, Executive Director, HSRAA
Jamie Toth, Director and Head of TMF Operations, DAIICHI SANKYO
Workshop Day Concludes
Main Conference | Day One | Wednesday, 2 October 2019
Registration and Continental Breakfast
Summit Co-Chairs’ Opening Remarks
Mieke Borgs, Global Head Clinical Document Governance and Management, GDO Trial Management, NOVARTIS
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Jane Twitchen, Director, Clinical Study Leadership, Global Clinical Operations, BIOGEN
PANEL: The Art of Improving Your TMF Quality Through Innovative Strategies and Innovative Activities That Can Impact Your TMF
  • Mitigate risks and maintain a compliant eTMF system
  • Implement proactive TMF oversight and manage TMF and business representative teams
  • Analyse the requirements of office-based inspections and how they impact your TMF
  • Standardise routine processes and minimum expectations and oversight for external partners
  • Discuss the implications of regulatory developments and inspection trends on sponsors, CROs, and sites
  • Explore the impact of ePro and emerging technologies on data integrity and compliance
  • Weigh the pros and cons of developing in-house document management systems

Jamie Toth, Director and Head of TMF Operations, DAIICHI SANKYO


Jeannette Dixon, Independent GCP Quality Assurance Consultant, JQAGCP QUALITY ASSURANCE
Renee Heuser, Director, Clinical Documentation Center, ABBVIE
Etienne Hinton, Clinical Trial Coordinator, DUKE CLINICAL RESEARCH INSTITUTE

Explore How Digital Disruption Is Shaping the New World of TMF Technology
  • Survey TMF evolution from paper to file-sharing to eTMF
  • Anticipate the role disruptive technology will play in meeting our future needs
  • Balance this technology with experienced people trained on effective processes to reach the TMF Health Zone
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Barry Sacks, Chief Technology Officer, PHLEXGLOBAL
Networking Break
Explore the Impact of ePRO and Emerging Technologies on Data Sharing and Compliance
  • Survey the panoply of technologies and devices that inputting ePro and other data into eTMFs
  • Recognise the risks and challenges adoption of eConsent and use of eSignatures
  • Discuss the pros and cons of apps, wearables, and handheld technologies
  • Prepare for the impact that new technologies will have on data integrity and privacy
CRO Panel: Improve Inspection Readiness With a Collaborative Approach CRO-Sponsor Partnerships
  • Hear best practices on TMF collaboration between sponsor and CRO
  • Discuss pros and cons of using a CRO-owned eTMFs versus sponsor-owned eTMFs
  • Learn actionable insights and improve internal and external processes through training and support
  • Garner multiple perspectives on governance strategies and oversight practices
  • Hear how CROs account for quality in their own systems
  • See audits and inspections from the point of view of CROs

Karen Roy, Chief Strategy Officer, PHLEXGLOBAL


Molly Brock, Director, Clinical Operations, PRA HEALTH SCIENCES
Colleen Butler, Director, TMF Operations, SYNEOS HEALTH
Michelle Ingraham, Manager, Information Governance and Compliance, PPD

Tracked Sessions | Main Conference Day One | Wednesday, 2 October 2019
Disruptive Technology
Quality Management
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Jane Twitchen, Director, Clinical Study Leadership, Global Clinical Operations, BIOGEN
Case Study Data-Driven eTMF — Towards Improved Quality, Timeliness, and Completeness
  • Ensure quality, timeliness and completeness of eTMF by using operational data to interconnect clinical processes, activities and events
  • Gain visibility of what artefacts are required and the lack of triggers present to prompt contributors
  • Employ operational data and data management strategies to ensure the highest quality eTMF
  • Improve how we predict and manage artefacts through the use of predictive analytics based on central process models and data management techniques
Paul Fenton, Founder and CEO, MONTRIUM
Gilead Case Study: Question Your Clinical Trial Oversight — Does Your TMF Tell the Whole Story of What’s Happening
  • Consider ownership of the TMF across functions, at CRO, and at ‘site’
  • Take control of areas risks and challenges
  • Share information and milestones with dashboards and reports
  • Reframe your mindset to reform your approach from ‘just in case’ inspection readiness to ’steady state’ inspection readiness
  • Have the answer to what is happening in your study at your fingertips!
Wendy Koç, Senior Manager Clinical Compliance, GILEAD SCIENCES
Transition Time
Novartis Case Study: Use AI for Document Migration to and Document Management
  • Hear lessons learned from Novartis' planning process and from the engagement of functional units
  • Discuss the limitations of AI and QCs that should be in place before and after migration
  • Identify prerequisites and risks of applying AI and machine learning to metadata and data integrity
  • Explore the AI interface between business and technology
  • Consider feature requirements and adaptability when vetting/selecting tools for a technical migration transfer
Matthias Wittig, TMF Business Lead Consultant, ARCONDIS
Panel Discussion Understand the Importance of Data Integrity in Clinical Trials and TMF
  • Analyse the impact your data has on your TMF and clinical trial as a whole
  • Pinpoint the benefits of achieving data integrity
  • Discuss common pitfalls and how to address them
  • Gain solutions for attaining and maintaining data integrity

Michelle Lauren Savage, Senior Consultant, BASE Life Science


Jane Bushell, Associate Director, Clinical QA, EISAI
Dorte Frejwald Christiansen, Competency Development Specialist, NOVO NORDISK
Eldin Rammell, Executive Director, HSRAA

Networking Break
Leverage Automation to Bring in Elements From the Systems of Other Functions
  • Review functional systems that draw from or impact eTMF content
  • Look at the relationships between document types that relate to GCP and GXP integration
  • Comply with data integrity and privacy requirements of other systems
  • Improve eTMF workflow processes alignment with the way that trial documents are used, created, sorted, and reported on
  • Expedite and augment interoperability by using AI to extract artefacts, emails, and data
Martina Duevel, Systems Excellence Project Leader, BAYER
Eli Lilly Case Study: Integrate Essential Safety Documents Into Your eTMF and Comply With Article 57
  • Hear how Eli Lilly engages stakeholders in other clinical functions for a more seamless roll-out
  • Survey safety trial document types and requirements with a risk-based mindset
  • Ensure access for inspectors and auditors to verify trial conduct and data quality
  • Incorporate safety requirements in your TMF plan, index and filing strategy, and sponsor oversight
  • Overcome barriers to file safety documentation in eTMF
Lucy Hampshire, Director, Medicines Quality Organisation – International, ELI LILLY
Transition time
Novo Nordisk Case Study: Manage Emails by Machine Learning to Improve Consistency, Cut Costs, Lessen Oversight Demands Without Compromising Quality
  • Explore considerations for looking at data to use machine learning
  • Discuss Natural Language Processing of TMF emails
  • Demonstrate rules and outcomes and how they were determined
  • Identify the limitations, predictable and unpredictable pitfalls of automatizing email classifications
  • Discuss outcomes, lessons learned and actionable insights for pilot and implementation stages
Adam Lenart, Senior Big Data Science, NOVO NORDISK
Novo Nordisk Case Study: Plan and Execute Migration to a New eTMF System Using Machine Learning
  • Hear about specific challenges and lessons learned related to migration using machine learning
  • Create a road map with cross-functional groups
  • Consider the QC that must be in place in multiple stages
  • Feedback mechanism and governance practices to support continued process improvement
  • Look at an approach to training and support strategies for roll-out and beyond
  • Establish responsibilities and provide essential training for internal functions
  • Discuss the effectiveness of agile project methodology
Dorte Frejwald Christiansen, Competency Development Specialist, NOVO NORDISK
Michelle Lauren Savage, Senior Consultant, BASE Life Science
Transition Time
Under the Microscope: Examine and Diagnose TMF Health, a Syneos Health and Sponsor Case Study of Inspection Readiness
  • Hear about a study-level case study of Inspection preparation between Syneos Health and Sponsor
  • Evaluate and asses TMF Health as an indicator of overall Inspection Readiness
  • Implement corrective actions to drive TMF Health Restoration in the short term
  • Establish habits and behaviours to maintain TMF Health in the longer term
Colleen Butler, Director, TMF Operations, SYNEOS HEALTH
GlaxoSmithKline Case Study: Ensure Data Integrity When Migrating Your eTMF
  • Ask the right questions when selecting eTMF systems
  • Determine and prioritise risks
  • Determine QC measures to be taken before, during, and after migration
  • Anticipate challenges and avoid pitfalls of extracting artefacts, emails, and other document types
  • Maintain integrity and compliance of eTMF system data that is integrated with other systems
Vittoria Sparacio, Head, Clinical Documentation Operations, R&D Projects, Clinical Platforms and Sciences, GLAXOSMITHKLINE
Day One Concludes
Tracked Sessions | Main Conference Day Two | Thursday, 3 October 2019
Business Integration
Continental Breakfast
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Mieke Borgs, Global Head Clinical Document Governance and Management, GDO Trial Management, NOVARTIS
Biogen Case Study: Starting Off a Partnership on the Right Foot With Oversight and Governance That Make a Difference to Inspection Readiness
  • Learn how Biogen cross-functionally defined a way of working with a new partner
  • Align on expectations and support with key metrics and oversight
  • Integrate TMF with other systems, ensuring process optimisation
  • Accelerate activation without compromising data integrity
  • Overcome transparency issues and consolidate cross-functional governance
Jane Twitchen, Director, Clinical Study Leadership, Global Clinical Operations, BIOGEN
Novartis Case Study: Ensure That Processes and Governance Are in Place to Meet EMA's Requirements
  • Survey EMA requirements and focus on a few key pain points
  • Discuss with other functions participating in TMF governance team to align processes with regulations as needed
  • Examine at common challenges to oversight
Magalie Lemoine, Trial Master File Governance Office Lead, NOVARTIS
Reducing the eTMF Operational Burden Using Risk-Based Approaches

In this presentation, Lou and Gill will examine how quality risk management principles in clinical trials can be applied to TMF quality and completeness, and where to focus resource in order to achieve a high-quality and inspection-ready TMF.

Gillian Gittens, Customer Success Manager, IQVIA TECHNOLOGIES
Chugai Case Study: Look at an Approach for Influencing Decision-Makers Across Cultures
  • Look at the process for overcoming multiple challenges to implement an eTMF
  • Compare and contrast the benefits of using sponsor-owned eTMF
  • Develop a TMF Management Plan in cooperation with your CRO to ensure persuasiveness and effectiveness
  • Discuss change management strategies
  • Compare and contrast three CROs’ a TMF management plan
Sally Digby, Senior Document Specialist, CHUGAI
AstraZeneca Case Study: Make Your Oversight for Functional Process Owners Actionable With Good Governance and Change Management
  • See how AZ’s Governance Control Board is structured and operates to foster cooperation
  • Enable other functional process owners and offer supports to comply with processes
  • Study dashboards with tailored measurements and metrics
  • Customise KPIs and other metrics to reflect meaningful and actionable outcomes
Andreas Järemo, TMF Global Lead, ASTRAZENECA
Networking Break
Boehringer Ingelheim / IQVIA Case Study: Sponsors and CROs: Work Together to Improve Quality and Inspection Readiness
  • Hear perspectives and best practices from sponsor and CRO on their partnership
  • Identify challenges in the work stream across sponsors and CROs
  • Apply current regulations by adopting the risk-based approach
  • Customise KPIs and other metrics to reflect meaningful and actionable outcomes, reveal risk factors and facilitate solutions
  • Tailor dashboard and examine one multifaceted metric
  • Promote a culture of shared Quality by helping organisations gauge performance with shared metrics
  • Define inspection readiness and inspection support expectations for CROs
Helen Price, Head of TMF Solutions, IQVIA
Carina Teufel, Global TMF Records Specialist, BOEHRINGER INGELHEIM
EU TMF Guidance – What’s New?
  • Understand the new requirements outlined in the EU TMF Guidance, effective since June 2019.
  • Learn how your business partners can be affected by required changes
  • Outline the changes that may be required in your operation procedures
  • Be aware of the defined approach to TMF archiving
Jeannette Dixon, Independent GCP Quality Assurance Consultant, JQAGCP QUALITY ASSURANCE
Prepare for a GCP Inspection — the TMF and Intersecting Quality Systems
  • Develop a robust TMF index mapping to other Quality Systems
  • File in the TMF as you go, you will regret it if you don’t!
  • Discuss inspection readiness tools and methodology
  • Create cross-functional storyboards for complex issues
  • Learn about common inspection findings
Suzanne Murray, VP, Quality, AGIOS PHARMACEUTICAL
Eli Lilly Case Study: Conduct Oversight to Improve the User-End Experience of Business Units
  • Look at how processes and procedures have been modified to integrate TMF
  • Adapt metrics measurement and checking criteria to reveal problem areas
  • Explore the impact that bots and automation have on compliance
  • Discuss training and supports that have been established and lessons learned about improving their impact
William Chesterfield, Global Trial Capabilities Leadership, ELI LILLY
Co-Chairs’ Closing Remarks
Mieke Borgs, Global Head Clinical Document Governance and Management, GDO Trial Management, NOVARTIS
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Jane Twitchen, Director, Clinical Study Leadership, Global Clinical Operations, BIOGEN
Summit Concludes

Request Event Documentation

Conference Documentation Now Available Conference Documentation

live chat software