New York Professional Events List

6th European Trial Master File Summit

Oct 16, 2017 - 08:00 AM - Oct 19, 10:00 PM
Link to Website
ExL Events
London Marriott Hotel Regents Park
128 King Henry'S Road,

London ,

ExL Pharma’s European Trial Master File Summit continues to be the #1 source of information and replicable best practices in the life science industry. The quality and immediate relevance of topics are rivalled only by the calibre and zeal of our expert speaking faculty as well as the enthusiasm of participants at the event each year — and there is good reason for this.

This conference is by and for TMF™ professionals who play an active role in the identification and development of topics prior to the event. This event features a balance of:

  • Select case studies vetted for relevance and scrutinised for poignancy
  • Facilitated and informal peer-to-peer learning opportunities
  • Broadly representative panels with complementary viewpoints
  • Interactive sessions and workshops
  • Industry leaders, preeminent experts, solution providers

At the summit, the interaction among this group of like-minded learners and leaders generates an unparalleled exchange of ideas and adaptation of strategies and tools. This October, 120+ participants, ranging from beginner to expert, will actively delve into principles, discuss pitfalls, discover strategies, and vet best practices suited to their TMF needs.

The 40+ speakers of 6th European TMF Summit are eager to confer the lessons they have learned on a wide yet cohesive range of topics tailored to your critical need for information, tools, savvy and professional development that will prepare you to return to work to

  • Improve TMF/eTMF system quality through a defined structure and QC
  • Monitor the TMF/eTMF process for completeness and compliance
  • Guarantee inspection readiness through streamlined SOPs and sound governance
  • Effect and demonstrate the integrity of the trial data
  • Refine oversight of trials with proven metrics and tactical KPIs
  • Prepare for inspections with the benefit of regulatory and inspection trend updates

Audience Breakdown



Trial Sponsors CRO Service Providers Sites



Manager VP/Director Regulatory Associate Coordinator/Records Manager C-level Specialist

Who Should Attend

This conference is designed for representatives from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in the following areas:

  • TMF™ and eTMF Process Management
  • Clinical Document/Data Management
  • Clinical Trial Administration
  • Clinical Operations
  • Regulatory Affairs/Operations
  • Trial, Document and Record Management
  • Clinical Document Coordination
  • Clinical Development/Study Management
  • Quality Assurance/Control/Operations
  • Competency Development
  • Strategic Operations and Planning
  • Quality Management
  • Informatics
  • Clinical IT

This conference is also of interest to:

  • eTMF System Service Providers
  • Data/Records Management Vendors
  • Clinical Research Organizations
  • Paper and Electronic Archiving Solution Providers
Europe - Workshops | Monday, 16 October 2017
Registration and Continental Breakfast
Review eTMF System Capabilities and Needs to Create a Clear Process and Efficient Ways to Utilise the System
An eTMF system is no longer something that organisations consider to be an optional extra. It’s now recognised as an essential tool that can help with the basic functions of collecting, sorting and ensuring the quality of your documents to ensure that the trial is GCP compliant. Further, it can and should be a critical tool to facilitate study management. Whether you have a purpose-designed eTMF system or a general document management system, you will need to have a process in place to utilise this technology strategically to improve your process and ensure alignment with your eTMF system. During this workshop, attendees will work their way through typical eTMF system functionality and align this with clinical trial processes to walk away with the understanding to:
  • Have full control and oversight of your eTMF system, so it becomes a user-friendly tool for study management
  • Understand enhancements and system updates
  • Create an efficient eTMF process workflow process, aligned with the way that trial documents are used and created
  • Utilise your technology to apply quality control
  • Have strategic processes to collect and file documents
*This workshop includes a 30-minute networking break.
Eldin Rammell, Managing Director, RAMMELL CONSULTING
Jane Twitchen, Associate Director, Global Clinical Operations, BIOGEN
Luncheon for Workshop A Attendees
Select and Implement an Out-of-the-Box eTMF System – An Interactive Workshop
Vetting eTMF systems can be a very large undertaking whether your company is large or small. The implementation project can be even larger and take extended time unless tight controls for scope and activity completion are adhered to by all. For the best chance of success, it is important to 1) use available tools/resources where they exist so as to not reinvent the wheel; 2) assign the right people to the project; and 3) garner heavy investment from senior management to ensure prioritisation in the project team members’ work schedules. This workshop will utilise a very recent, very successful case study of a small biotech company to review, step by step, through the eTMF system selection process and 21-day implementation project. Goals of the workshop attendees are:
  • Create the scope of the project, beginning with the development of the questions to understand the goals of the project from start to finish
  • Use the proper tool for the creation of the RFP for facilitating vendor vetting and selection
  • See the request for project approval and funding through the eyes of senior management
  • Review the critical-to-success roles on the eTMF system implementation team
  • Evaluate the project plan template determine and preempt possible delay and pitfalls
*This workshop includes a 30-minute networking break.
Neil Bell, Head of Clinical Operations, AUTOLUS
Lisa Mulcahy, TMF Management Consultant, MULCAHY CONSULTING
Workshop Day Concludes

Registration and Continental Breakfast
Co-Chairs’ Opening Remarks
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Vittoria Sparacio, Head, Clinical Documentation Operations, GLAXOSMITHKLINE
Analyse on GCP Compliance in Relation to Trial Master File for Content, Management, Archiving, Audit and Inspection of Clinical Trials
  • Maintain an inspection-ready TMF system that achieves GCP compliance and demonstrates the integrity of the trial data
  • Mitigate risks to compliance of EMA’s guidelines on GCP
  • Refine your document management process to mitigate the impact of your TMF system's structure and content
Consider Best Practices to Prevent Critical Findings
  • Hear a regulatory update on inspection trends and their impact on TMF management
  • Anticipate and prepare for the effects of data integrity requirements and for ICH E6 on TMF documentation
  • Integrate the new terminology for GCP records management
  • Maintain an inspection-ready TMF process that demonstrates the integrity of the trial data
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Networking Break
Ensure a High-Quality TMF System Through Positive CRO/Sponsor Interactions and Oversight
  • Maintain CRO/sponsor oversight plans that directly outline roles and responsibilities for all documentation processes
  • Identify challenges in the work stream across sponsors, CROs and investigator sites
  • Utilise an eTMF application to drive trial efficiency, improve collaboration and help organisations gauge performance with shared metrics
  • Adopt best practices to create and maintain a compliant and high-quality workflow
Jamie Marie Toth, Head of TMF Operations, DAIICHI SANKYO
Transition From TMF to eTMF: Tips and Tools for Minimizing the Pains of Change
  • Hear recommendations for getting the most of your paper TMF
  • Transition from paper TMF to eTMF in a phased approach using prove n strategies
  • Discover how TMF management includes but is not limited to document management
  • Facilitate sharing and providing access to TMF content for third parties by plying metadata
Patricia Santos-Serrao, RAC, Director, Clinical and Regulatory Solutions Pharmaceutical, Blood and Biologics, MASTERCONTROL
Networking Luncheon
Case Study Develop and Rollout a TMF Management Plan With CRO for Sandoz Biosimilar Clinical Development
  • Understand the need for an integrated plan to ensure your CRO performs TMF system filing according to agreed standards
  • Explore the topics that need to be included in the TMF management plan and their correlation to EMA’s recommendations
  • Discuss the following experiences that relate to defining content of TMF management plans:
    • Creating a mapping structure for a table of contents
    • Agreeing on formats for sponsor quality check reports
    • Transferring complete eTMF files to sponsor after study closeout
Claudia Panitz, Head Regulatory Readiness and Archival/ GDO, NOVARTIS
Panel Utilise an eTMF System to Monitor All Aspects of the TMF Process, Vendors, Quality and Clinical Research Sites
  • Understand how to utilise your eTMF system to monitor and enhance vendor governance
  • Recognise the changes underway in clinical quality oversight operations in light of the changing regulatory environment
  • Identify the benefits of a conceptual framework for a proactive approach for end-to-end management of issues generated through clinical research activities
  • Implement KPIs and metrics to monitor outsourced functions in order to have better oversight of the trial
  • Harness the impact of an eTMF system to increase quality
Jeannette Dixon, Associate Director, Clinical Operations Quality Oversight, BIOGEN
Jeff Pilot, Senior Clinical Project Manager, NORGINE
Networking Break
Take a Behind-the-Scenes Tour of Active eTMF Management
  • Achieve a timely and complete eTMF
  • Work in real time and factors to consider
  • Balance time invested with quality and risk expectations
Franciska Darmer, Director, Veeva Vault eTMF Strategy, VEEVA SYSTEMS
Address TMF Strategy Considerations for Essential Safety Documents to Be Compliant With Article 57
  • Survey safety trial documents necessary to allow verification of the trial conduct and data quality
  • Incorporate of safety requirements in your TMF plan, index and filing strategy, and sponsor oversight
  • Overcome barriers to file safety documentation in eTMF systems
  • Discuss examples of how to manage during inspections and audits
Lucy Hampshire, Director, Medicines Quality Organisation - Europe, ELI LILLY
Jennifer Maier, Associate Director, R&D Quality Compliance, ALEXION PHARMACEUTICALS
Day One Concludes

Registration Opens and Continental Breakfast
Co-Chairs’ Recap of Day One
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Vittoria Sparacio, Head, Clinical Documentation Operations, GLAXOSMITHKLINE
Oversee an eTMF Process for a CRO-Run Study With Proven Processes and Tools
  • Perform due diligence on a vendor eTMF process by identifying and prioritising what you are looking for
  • Clarify sponsor needs and expectations for access to a CRO’s eTMF system
  • Survey the types of evidence sponsors should be prepared to provide
  • Vet electronic tools for supporting due diligence
  • Discuss actions that should be taken at closeout
Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY
Martin Hausten, Team Lead Global Document Specialist, Head of Global Document Quality Content, BOEHRINGER INGELHEIM
Case Study CASE STUDY: Bolster eTMF System Compliance and Data Quality Though Metrics, Dashboards and Automation
  • Set objectives for eTMF monitoring
  • Establish KPIs
  • Survey techniques for gathering data and data assessment
  • Visualise and disseminate information effectively
  • Establish Trial Team Response protocols and feedback loops
  • Consider future possibilities with technological advancements such as marts, clouds, robots, machine learning
Timothy Rafferty, eTMF Quality and Metrics Manager, ROCHE
Networking Break
Case Study Apply a Risk-Based Approach to Your TMF Process
  • Enhance your QC process and your approach to document management
  • Utilise risk to ensure a TMF system is of the best quality when originally put in the TMF process
  • Identify facets of the TMF process that have the highest probability for quality issues
  • Manage the impact of implementing an eTMF system under strict budget constraints
Ruth Coll, Senior Clinical Program Manager, TRIZELL
Assure TMF System Quality Through the Engagement of People and Establishment of Processes and Systems
  • Examine the direct correlation of proper TMF system quality management procedures for improved decision-making and inspection readiness
  • Analyse TMF data to assess the current quality of your TMF system and identify weaknesses
  • Leverage analysis conclusions and patterns to inform improvements to your document management system and tools
  • Harness metadata and a defined folder structure to engender an up-to-date TMF process
  • Identify areas of focus for further training and professional development via TMF system quality management
Dorte Frejwald Christiansen, TMF Lead, Principal Consultant, NNIT
Networking Luncheon
Case Study Define, Monitor and Remain Inspection-Ready
  • Define what inspection-ready means to the organisation and the trial
  • Understand internal stakeholders who contribute to the TMF process to ensure they are adding compliant documents
  • Ensure that your definition of a complete TMF system is consistently conveyed throughout your organisation
  • Vet strategies to remain inspection-ready
Case Study Document and Content Management Part of a Robust Quality Management System
  • Implement document and content management as integral components of a quality management system
  • Get an overview of methods for evaluating processes and operations
  • Demonstrate the process by which a pathway to improvement is delivered
Scott McCulloch, Associate Director, Development Sciences Quality, BIOMARIN EUROPE
Networking Break
Understand the Impact and Showcase the Process of Documentation Within the TMF Process
  • Look at the TMF system as a deliverable and not as a document structure
  • Comprehend the process of the TMF process and the larger picture of inspection preparation
  • Include ICH GCP R2 regulations into the oversight of documents from vendors
  • Modify a TMF structure so that an inspection can find documents and all corresponding documentation appropriately
Nancy Meyerson–Hess, Associate Partner; Former Head of Clinical Operations and Compliance, ADMEDICUM BUSINESS FOR PATIENTS; GRUNENTHAL
Ensure TMF Completeness
  • Manage unstructured and structured content
  • Leverage milestones and dashboards to encourage and oversee completeness
  • Communicate definitions of and expectations for completeness to internal allies and external partners
  • Compare the facets and functionality of electronic tools for their suitability for studies of disparate natures and designs
  • Ensure completeness of documents prior to being put into the system
Wendy Koç, Senior Manager Clinical Compliance, GILEAD SCIENCES
Conference Concludes

Please contact Marilyn Turner: +1 929 900 1853  for registations


Event Categories
Life Sciences, Biotechnology
Keywords: fun, analysis, access , administration , arts, assessment , audience, business , Clinical , conference


Events Calendar

1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30 31 1 2 3 4

Event Location


VIP Life Time Subscription to our Newsletters!

Forbes Women's Summit 2018
Disrupt SF 2018 - Brought to you by Techcrunch
U.S. Naval Institute Annual Meeting 2018
Breast Cancer Research Foundation
Children’s Health Fund
The World Energy Engineering Congress (WEEC)
                            Oct. 17-19, 2018
                            Charlotte, NC