Past event: European Trial Master File Summit

Improve Inspection Readiness and TMF Quality Through Judicious Design, Processes and Governance of a Suitable TMF Model

Our 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

Speakers

  • Neil Bell, Head of Clinical Operations, AUTOLUS
  • Dorte Frejwald Christiansen, TMF Lead, Principal Consultant, NNIT
  • Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY, A QUINTILESIMS COMPANY
  • Ruth Coll, Senior Clinical Program Manager, TRIZELL
  • Franciska Darmer, Director, Veeva Vault eTMF Strategy, VEEVA SYSTEMS
  • Jeannette Dixon, Associate Director, Clinical Operations Quality Oversight, BIOGEN
  • Lucy Hampshire, Director, Medicines Quality Organisation - Europe, ELI LILLY
  • Martin Hausten, Team Lead Global Document Specialist, Head of Global Document Quality Content, BOEHRINGER INGELHEIM
  • Jennifer Maier, Associate Director, R&D Quality Compliance, ALEXION PHARMACEUTICALS
  • Scott McCulloch, Associate Director, Development Sciences Quality, BIOMARIN EUROPE
  • Nancy Meyerson–Hess, Associate Partner; Former Head of Clinical Operations and Compliance, ADMEDICUM BUSINESS FOR PATIENTS; GRUNENTHAL
  • Lisa Mulcahy, TMF Management Consultant, MULCAHY CONSULTING
  • Claudia Panitz, Head Regulatory Readiness and Archival/ GDO, NOVARTIS
  • Jeff Pilot, Senior Clinical Project Manager, NORGINE
  • Timothy Rafferty, eTMF Quality and Metrics Manager, ROCHE
  • Eldin Rammell, Managing Director, RAMMELL CONSULTING
  • Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
  • Vittoria Sparacio, Head, Clinical Documentation Operations, GLAXOSMITHKLINE
  • Jamie Toth, Head of TMF Operations, DAIICHI SANKYO
  • Jane Twitchen, Associate Director, Global Clinical Operations, BIOGEN
  • Emma Webby-Mears, Senior Clinical Document Manager, VECTURA GROUP

Please fill in your name and email to receive the conference agenda of this event.


Workshop Day - Monday, October 16, 2017

Conference Day One - Tuesday, October 17, 2017

Conference Day Two - Wednesday, October 18, 2017

The agenda is available as PDF under downloads at the right side of the page.

Venue

London Marriott Hotel Regents Park
128 King Henry's Rd, NW3 3ST
London, UK

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


Venue

London Marriott Hotel Regents Park
128 King Henry's Road
London, England NW3 3ST

The London Marriott Hotel Regents Park facilitates brilliant travel here in England’s capital city, with family-friendly accommodation and an exceptional location. You’ll find us in the heart of North London, steps from the famous Regent’s Park and within walking distance of Swiss Cottage Underground station. Our spacious and intuitively designed rooms and suites offer deluxe pillow-top bedding and high-speed Wi-Fi; many also feature balconies. Our convenient location enables you and your family to discover the best of North London – from Camden Market and ZSL London Zoo to Primrose Hill and Baker Street. Discover a winning combination of style and substance at the London Marriott Hotel Regents Park!​

To make reservations please call 0800 221 222 and request the negotiated rate for ExL's 6th European Trial Master File Summit. To make reservations online Click Here

The group rate is available until September 25, 2017. Please book your room early as rooms available at this rate are limited.
Event details
Organizer : ExL
Event type : Conference
Reference : ASDE-17269