PRECONFERENCE WORKSHOPSMONDAY, 15 OCTOBER

“PROFOUND AND DEEP INSIGHT INTO ALL ASPECTS OF TMF MANAGEMENT.”

—Head, Clinical Documentation, CHIESI FARMACEUTICALS

8:00 Registration and Continental Breakfast

9:00 WORKSHOP A

TMF Management PlanNever 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.

12:00 Luncheon for Workshop A Attendees

13:00 WORKSHOP B

TMF Quality Control: Leveraging TMF Quality Data to Improve Study and Vendor ManagementThe 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.

16:00 Workshop Day Concludes

2017 TESTIMONIALS

“GOOD PRESENTATIONS, GOOD DISCUSSIONS, A LOT OF NETWORKING.”

—TMF Category Leader, ASTRAZENECA

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8:00 Registration and Continental Breakfast

8:45 Co-Chairs’ Opening Remarks Karen Roy, Chief Strategy Officer, PHLEXGLOBAL Lucy Hampshire, Director, Medicines Quality Organisation — Europe, ELI LILLY

9:00 Keynote PresentationAndrew Fisher, Senior GCP Inspection, MHRA

10:00 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

Martina Duevel, Systems Excellence Project Leader, BAYER PHARMACEUTICALS

10:30 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 Product Leader, MEDIDATA

11:00 Networking Break

11:30 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

12:15 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

12:45 Networking Luncheon

TRANSITIONS Preparations and accommodations essential to compliance and

GCP for eTMF migration or times of change

CONTINUOUS IMPROVEMENT QC strategies and metrics essential to improved compliance,

inspection readiness and GCP

13:45 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 and Compliance, MEDIMMUNE

14:25 Transition Time14:30 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

Victoria Ho, Director, Clinical Operations, GILEAD

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 regional-based training and functional-based training

¡ Engage all users and manager levels to onboard them in the remediation work

Catarina Bergman, TMF Adoption Lead, ASTRAZENECA

CONFERENCE DAY ONE — TUESDAY, 16 OCTOBER

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8:00 Continental Breakfast

8:30 Co-Chairs’ Recap of Day OneKaren Roy, Chief Strategy Officer, PHLEXGLOBAL Lucy Hampshire, Director, Medicines Quality Organisation — Europe, ELI LILLYLILLY

8:45 Panel: Improve Inspection Readiness and QC Efficacy Through CRO and Sponsors Collaboration ¡ Hear tips for better communications to and governance of CROs ¡ Promote collaboration by fostering CRO engagement, if not

ownership ¡ Identify QC and types of support that are helpful or

counterproductive ¡ Identify CRO stressors to inform your management plan and

monitoring plan ¡ Align KPIs to be compatible with a CRO’s operations, processes

and systemModeratorKathie Clark, Vice President Product Management, WINGSPAN TECHNOLOGY, A QUINTILESIMS COMPANYPanelistsAlison Hussain, Manager — TMF Management and Compliance, Global Regulatory Services and Operations (GRSO), EISAI

9:30 Case Study: Improve Processes Globally Using Data Analytics and a Risk-Based Approach ¡ Move from a passive to an active TMF using harmonised key data

elements and trial milestone information ¡ Learn how technology can help to make better decisions faster ¡ Look at a central TMF oversight process ¡ Understand purpose of key document units for TMF quality trend

analysis ¡ Assess TMF completeness by defining time checkpoints

Martin Hausten, Head of Global Document Quality Centre, BOEHRINGER INGELHEIM 

10:15 Networking Break

10:45 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?Moderator Paul Fenton, President and CEO, MONTRIUMPanelists Jamie Toth, Director and Head of TMF Operations, DAIICHI SANKYO

15:15 Networking Break15:45 Case Study: Prepare for Inspections With Strategic

Attendance to Archives  ¡ Survey different systems with archived TMF Documentation

and get an overview of TMF makeup ¡ Drive TMF inspection readiness, e.g., logistics, participants

and cooperation between departments/areas ¡ Ensure mapping of TMF documentation, including data

outside the primary eTMF ¡ Manag e inspector access to eTMF

Anna Szaff Lundsgaard, Senior Clinical Trial Administrator, NOVO NORDISKMaria Nymann Jensen, Competency Development Professional, NOVO NORDISK

Ensure Productivity and Compliance of an eTMF ¡ Streamline eTMF maintenance by assigning and clarifying

responsibilities of stakeholders ¡ Leverage filing efficiency within a complex TMF environment ¡ Improve oversight by transitioning from manual to automated ¡ Evaluate QC strategies — eTMF QC as one component of

study risk managementUte Kohlhaas, Head of Clinical Project Management Gynecology, BAYER

16:25 Transition Time16:30 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 systemsMieke 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, Clinical Documentation, SANOFI PASTEUR

17:15 Drinks Reception18:15 Day One Concludes

CONFERENCE DAY ONE — TUESDAY, 16 OCTOBER

CONFERENCE DAY TWO — WEDNESDAY, 17 OCTOBER

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11:30 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, GOOD CLINICAL PRACTICE ALLIANCE — EUROPE (GCPA) & STRATEGIC INITIATIVE FOR DEVELOPING CAPACITY IN ETHICAL REVIEW (SIDCER)

12:15 Networking Luncheon

13:15 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

systemsModeratorEldin Rammell, Managing Director, RAMMELL CONSULTINGPanelistsWendy Koc, Senior Manager, Clinical Compliance, GILEAD SCIENCES Vittoria Sparacio, Head, Clinical Documentation Operations, GSK R&D Processes, Clinical Compliance Platforms and Sciences, GLAXOSMITHKLINE

14:15 Panel: 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

ModeratorLucy Hampshire, Director, Medicines Quality Organisation — Europe, ELI LILLYPanelistsJenny Savva, Clinical Operations Manager, CANCER RESEARCH UKAnne-Mette Varney, Principal Competency Development Specialist, NOVO NORDISK

15:00 Co-Chairs’ Closing RemarksKaren Roy, Chief Strategy Officer, PHLEXGLOBAL Lucy Hampshire, Director, Medicines Quality Organisation — Europe, ELI LILLYLIL

15:15 Conference Concludes

CONFERENCE DAY TWO — WEDNESDAY, 17 OCTOBER

“A LOT OF NEW INFORMATION. IT WAS VERY USEFUL TO KNOW ABOUT TMF EXPERIENCE FROM OTHER COMPANIES.

AS A CRO, WE ARE VERY INTERESTED IN THE TMF ISSUES AND IT IS VERY IMPORTANT TO SEE TMF PROBLEMS FOR DIFFERENT POINTS OF VIEW.”

—Senior Documentalist, PSI

QUESTIONS? COMMENTS? Do you have a question or comment that you would like addressed at this event? Would you like to get involved as a speaker or discussion leader? Please email Brian Anderson, Senior Conference Producer, at banderson@exlevents.com.

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