Preconference Workshops | Monday, 15 October 2018
Registration and Continental Breakfast
TMF Management Plan

Never created a TMF Plan? Need some help? Now is your chance! The TMF Management Plan is the first artefact of the TMF Reference Model created by the DIA Working Group. You may ask…why is that? Because it is important! It sets the expectations for the Trial Master File for each clinical study. While its content will vary from company to company, in this workshop we will review the constructs of the TMF Plan Template created by a subgroup of the DIA TMF Reference Model and use real examples of how to create your plan for your company.

This workshop will review the expectations of regulatory authorities as well as best practices from the presenters.
Topics that will be addressed during this workshop are:

  • View the TMF Management Plan through the eyes of health authorities
  • Clarify how critical the TMF Management Plan is to overall TMF Management processes
  • Take a walkthrough of the TMF Plan Template created by the TMF RM subgroup, reviewing and explaining each component
  • Get and generate ideas for quality reviews
  • Draft creation of your own TMF Plan Template (or how to customise a TMF Plan Template for your company)
Jamie Toth, Director and Head of TMF Operations, DAIICHI SANKYO
Wendy Trimboli, Director, Head of TMF Management and Compliance, EISAI

*This workshop will include a 30-minute networking break.

Luncheon for Workshop A Attendees
TMF Quality Control: Leveraging TMF Quality Data to Improve Study and Vendor Management

The TMF has traditionally been perceived as a detriment to the extent that its value as an asset has been eclipsed. Effective communication and indeed the demonstration of the TMF as a value-add is essential to counter the all-to-often disproportionate and misguided focus on the drain on resources and encumbrance of a TMF. This workshop will provide you with the knowledge and skills you need to ensure that your TMF contributes to the top-line investment rather than a line item among your expenses.

To assure compliance with regulatory requirements, it is necessary to monitor the quality of TMF content, in terms of completeness, timeliness and the quality of the documents themselves. These quality control (QC) processes can be conducted in many ways and can generate vast quantities of data.

During this workshop, attendees will look at different aspects of quality control to:

  • Determine what level of QC is appropriate
  • Identify the optimum level of QC and how to measure it
  • Understand how industry-developed tools can support and simplify QC processes
  • Discover what TMF QC data could support study and vendor management
Eldin Rammell, Managing Director, RAMMELL CONSULTING
Jane Twitchen, Associate Director, Global Clinical Operations, BIOGEN

*This workshop will include a 30-minute networking break.

Workshop Day Concludes
London Walking Pub Tour — SOLD OUT

Join TMF professionals from around the world on this two-hour walking tour around Bankside in London, which includes stops at some of the most impressive pubs. This excursion will allow you to reconnect with past colleagues, meet new people, and get motivated before the main conference day.

*Cost £25 – Click here to register
*Drinks are included.

Conference Day One | Plenary Sessions | Tuesday, 16 October 2018
Registration and Continental Breakfast
Co-Chairs’ Opening Remarks
Lucy Hampshire, Director, Medicines Quality Organisation – International, ELI LILLY
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Keynote Presentation
Discuss Implications Regulatory Developments and Inspection Trends on Sponsors and CROs
The keynote presentation will
  • Illuminate challenges still seen during inspection process with case examples
  • Provide an EMA Guidance update
  • Expound upon the impact of ICH E6(R2) on TMF
  • Address and elucidate issues related to
    • Vendor/Sponsor TMF Interaction
    • Documents and Data and Their Retention
    • Draft Documents, Trackers and Certified Copies
    • Investigator Site Files and Portals
Andrew Fisher, Lead Senior GCP Inspector, MHRA
Leverage Benefits of Automation to Systems Interoperability
  • Survey the number of systems that use or contribute to eTMF content
  • Discuss automation benefits and limits to improving TMF systems and processes
  • Learn the TMF Exchange Mechanisms implications for TMF automation
  • Improve interoperability and speed with AI for extracting artefacts, emails and data
Panel Discussion
Advantages and Disadvantages of Automation
  • Learn how different companies are using automation for QC
  • Discuss the pitfalls and drawbacks of automation in maintaining Data Integrity
  • Debate whether automation is favourable or detrimental to the privacy and limited access stipulations of GDPR
  • Anticipate the impact of automation the work of TMF professionals with disparate responsibilities
  • Get tips for overcome challenges and hear lessons learned for TMF artefact management

Perry Steinberg, Regulated Content Management, General Manager and Product Leader, MEDIDATA


Stephen Nabarro, Head of Clinical Operations and Data Management, CANCER RESEARCH UK
Stephanie Viscomi, Associate Director, Clinical Trial Office, IMMUNOGEN
Vincent Yeung, Senior Manager, Compliance, AMGEN

Networking Break
Wield Tactical and Practical Metrics and Methods for Monitoring and Management to Improve Quality
  • Determine and customise indicative areas to measure based on the needs of the trial
  • Identify and construct metrics for facets or components that indicate success in key areas
  • Avoid apparent and hidden pitfalls of assessing
  • Discuss limitations to what can be measured
  • Establish a proper system for detecting problems based on TMF metrics review
  • Hear lessons learned and go over a wish list of improvements
Gergana Koutsarova, Global TMF Process Owner, ASTRAZENECA
Apply Machine Learning and Artificial Intelligence
  • Hear case examples of AI application in TMF
  • Anticipate the skill sets that will need to be phased in/out
  • Learn the benefits and risks of AI and machine learning to Quality and inspection readiness
  • Determine where/how your particular needs should guide the level/ type of AI
  • Discuss the impact of AI on TMF processes and what adaptations are needed
  • Look at the future role of AI to TMF and the industry
Barry Sacks, Chief Technology Officer, PHLEXGLOBAL
Networking Luncheon
Conference Day One | Track Sessions | Tuesday, 16 October 2018
Preparations and accommodations essential to compliance and GCP for eTMF migration or times of change
QC strategies and metrics essential to improved compliance, inspection readiness and GCP
Acquisition Case Study: Amalgamate Historical File With eTMF Systems
  • Understanding and aligning TMF structure and metadata
  • Ensure Quality without sacrificing speed
  • Executing operationally whilst accessing the right document
  • Ensure inspection readiness
Jane Twitchen, Associate Director, Global Clinical Operations, BIOGEN
Improve Compliance Through Effective QMS
  • Understand regulatory requirements specific to TMF
  • Survey Inspection trends and statistics — and how not to be one of them!
  • Use audits as an added value QMS/oversight tool
  • Hear lessons learned: Auditors and auditees
  • Discuss CAPA and process improvement
Paul Stewart, Associate Director, Clinical Quality & Compliance, MEDIMMUNE
Transition Time
Case Study
Plan and Execute Migrations of Disparate Types of TMFs
  • Anticipate and avoid inspection readiness pitfalls
  • Determine what QC measures should be taken before and after migration
  • Hear about specific challenges and lessons learned in various scenarios, including:
    • CRO Paper TMF to Sponsor eTMF
    • CRO eTMF to Sponsor eTMF
    • Mid-Study Paper TMF to Sponsor eTMF
    • Transition from Acquisition TMF to Sponsor eTMF
Wendy Koç, Senior Manager Clinical Compliance, GILEAD SCIENCES
Case Study
Engage Internal Allies in eTMF Implementation and Remediation
  • Analyse the experience and impact of AZ’s hands-on global TMF Tour for post-migration support
  • Hear how multiple internal teams were activated to plan implementation and remediation
  • Compare and contrast functional team engagement with remediation committees and process work
  • Look at AZ’s process of surveying users’ experiences to discern or detect areas in need of solutions
  • Discuss lessons learned from including TMF stakeholders in regionalbased training and functional-based training
  • Engage all users and manager levels to onboard them in the remediation work
Catarina Bergman, TMF Adoption Lead, ASTRAZENECA
Transition Time
Case Study
Prepare for Inspections
  • Drive TMF inspection readiness, e.g., logistics, participants and cooperation between departments/areas
  • Ensure mapping of TMF documentation, including data outside the primary eTMF
  • Manage inspector access to eTMF
Maria Nymann Jensen, Competency Development Professional, NOVO NORDISK
Annebeth Siø Jensen, Principal Competency Development Specialist, NOVO NORDISK
Reclaim and Reform Your eTMF Through KPI’s, Storyboards and Team Alignment
Stephanie Viscomi, Associate Director, Clinical Trial Office, IMMUNOGEN
Networking Break
Ensure GCP When Migrating Your eTMF
  • Migrate your eTMF: What does it bring you?
  • Migrate everything or migrating part — considerations for a risk-based approach
  • 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
Mieke Borgs, Global Head Clinical Document Governance and Management, GDO Trial Management, NOVARTIS
TMF QC — to the Document Level and Beyond!
  • Ensure document-level compliance beyond completion requirements
  • Redefine/re-envision QC to encompass TMF Readiness factors (e.g., indexing, completeness, naming conventions, etc.)
  • Minimise risk caused by accounting for the human factor and inherently flexible tools
  • Construct or vet existing tools for completeness and efficacy
  • Delegate QC types to where the competencies are strongest
Meredith Lafond-Phésans, TMF QC Operational Manager, SANOFI PASTEUR
Transition Time
Move to a Global Harmonised eTMF Process Supported by Technology
  • Establish end-to-end TMF processes for planning, tracking, managing, archiving and reporting
  • Set up the list of expected records as a success factor for TMF
  • Implement a central TMF oversight process by defining metrics and using an integrated reporting engine
  • Consider and discuss technology that will facilitate and automate the processes to make better decisions faster
William Hamilton, Senior Product Integrator, DXC TECHNOLOGY
Case Study
Improve Quality and Execute a Culture Change Through Assessing and Addressing TMF Stakeholder Input
  • Understand how process changes driven by TMF stakeholder input will improve management and quality of TMF records
  • Develop a culture change and implement across regions and functions
  • Create a governance structure with clear accountability for contributing functional areas
  • Implement a quality oversight process with functional accountability
Tonya Edison, Director, Trial Capabilities, Trial Master File and Records Management, ELI LILLY
Networking Reception
Day One Concludes
Conference Day Two | Wednesday, 17 October 2018
Continental Breakfast
Co-Chairs’ Recap of Day One
Lucy Hampshire, Director, Medicines Quality Organisation – International, ELI LILLY
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Sponsors and CROs: Working Together to Improve Quality and Inspection Readiness
  • Debate the pros and cons of Sponsor-defined QC requirements
  • Consider KPIs that contribute to eTMF excellence and support oversight
  • Define inspection readiness and inspection support expectations for CROs
  • Hear best practices on TMF collaboration between sponsor and CRO
  • Ensure all sponsor’s documents are filed in the TMF

Kathie Clark, Senior Director, Product Management, WINGSPAN TECHNOLOGY, AN IQVIA COMPANY


Christopher Betts, Clinical Operations Manager UK Country Head, DOCS GLOBAL
Alison Hussain, Manager — TMF Management and Compliance, Global Regulatory Services and Operations, EISAI
Leanne Rice, Manager, Clinical Documentation Operations, GLAXOSMITHKLINE

Comply With EU’s Rule 1572 and Other Updated EU Regulations
  • Avoid common findings by identify pain points from case examples of inspections
  • Hear an inspector’s current thinking to data integrity and TMF/eTMF completeness
  • Discuss EU’s regulations and their implications for TMF
  • Outline the ramifications of Rule 1572 to companies that run trials globally
  • Identify discrepancies or conflicts between different regulatory authorities’ expectation
Philip Lange Møller, former Medicines Inspector, DANISH MEDICINES AGENCY
Networking Break
The Future of eTMF: What Are the Key Change Enablers?
  • Interoperability — essential requirements for machine to machine exchange of TMF content
  • Traceability and data integrity (need for a redefinition of audit trail)
  • Inspection readiness and wider scope — the challenge of inspection of multiple electronic systems
  • Connecting the dots, challenges in the presentation of TMF information and ability to tell an accurate story
  • To TMF or not to TMF — need for more specific guidance from the regulators; potential ratification of the TMF RM by ICH?

Paul Fenton, President and CEO, MONTRIUM


Sarah Curno, Contract TMF Specialist, HEDIAN RECORDS MANAGEMENT
Antonio Lio, Manager IGC, Quality and Enterprise Learning, PPD

Explore Areas of Focus That Relate to TMF Compliance With the GDPR
  • Know the impact of new European and member state privacy regulations on the TMF
  • Consider new or additional risks regarding the TMF due to the GDPR
  • Discuss practices for handling TMR data security breaches in the context of the GDPR
  • Define the role of
    • Data Controller vis-à-vis the TMR
    • Data Protection Officer vis-à-vis the GDPR
    • Data Supervisor vis-à-vis the GDPR
Francis P Crawley, Executive Director, GCPA & SIDCER
Networking Luncheon
Panel on GDPR
Learn What Other Companies Are Doing
  • Learn steps other companies have taken to change their systems
  • Discuss prioritisation drivers of your peers
  • Get insights on how your peers are educating, support, engaging or collaborating with internal departments
  • Compare the impact on third-party systems vs in-house
  • Look at how integration or interoperability will be affected by other systems


Gerard Lynch, Associate Director, Informed Consent Management, BIOGEN
Jeppe G. Manuel, R&D Personal Data Protection Specialist, NOVO NORDISK
Vittoria Sparacio, Head, Clinical Documentation Operations GSK Pharma R&D Projects, Clinical Platforms and Sciences, GLAXOSMITHKLINE

Prepare for Audits and Inspections and Follow Up With Intent
  • Compare and contrast what inspectors will look for in TMFs versus eTMFs
  • Take advantage of routine QC to determine what to focus on
  • Conduct mock inspections
  • Learn from audits in preparation for inspection
  • Identify red flags and language/responses that indicate issues

Lucy Hampshire, Director, Medicines Quality Organisation – International, ELI LILLY


Mark Poulton, Senior Manager, GCP QA, CLOVIS ONCOLOGY
Jenny Savva, Clinical Operations Manager, CANCER RESEARCH UK

FAQs You Want to Ask but Never Get the Chance
Andrew Fisher, Lead Senior GCP Inspector, MHRA
Co-Chairs’ Closing Remarks
Lucy Hampshire, Director, Medicines Quality Organisation – International, ELI LILLY
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Conference Concludes

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