European Trial Master File Summit

Networking, Actionable Lessons, and Replicable Strategies for Inspection Readiness With Governance, Oversight, and Disruptive Technologies


London, United Kingdom

The 8th European Trial Master File Summit is designed to put a focus on technology, processes, strategies, multiple points of view, and more which will allow attendees to gain a robust overview of how to manage, process, and enhance their TMF. Technology is now one of the essential means to establish tools that can assist with processes and resources that are necessary to support the use of the system. With the advent of eTMFs, sponsors are now able to achieve so much more beyond completeness for compliance with their TMF. Automation, machine learning and AI allow for the sorting, accessing, processing and analysing of more data, in less time - improving management oversight and efficacy of your Quality Management System. This year's event will feature quantity needed over three days, exploring how to:
  • Optimise eTMF workflow through interoperable technologies with the way documents are created, collected, managed, and reported on
  • Use disruptive technologies to improve efficiency, Quality, and metrics reporting
  • Garner new perspectives and insights from sites and CROs to improve Quality and compliance
  • Institute Quality Controls to meet oversight and monitoring requirements of ICH E6(R2) using a risk-based approach
  • Implement, migrate, acquire, and remediate eTMF systems in concert with other functional areas
We have expanded this year's programme to include two tracks on each day, so participants may better tailor their own learning and networking experiences.

On behalf of the Advisory Board and all of us, we look forward to welcoming you and 150+ of your peers to London this fall!

Who Should Attend

This conference is designed for representatives from pharmaceutical, biotech, medical device companies, and CROs 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 Organisations
  • Paper and Electronic Archiving Solution Providers

Speakers

  • Mieke Borgs, Global Head Clinical Document Governance and Management, GDO Trial Management - NOVARTIS
  • Molly Brock, Director, Clinical Operations - PRA HEALTH SCIENCES
  • Colleen Butler, Director, TMF Operations - SYNEOS HEALTH
  • William Chesterfield, Global Trial Capabilities Leadership - ELI LILLY
  • Dorte Frejwald Christiansen, Competency Development Specialist - NOVO NORDISK
  • Sally Digby, Senior Document Specialist - CHUGAI
  • Jeannette Dixon, Independent GCP Quality Assurance Consultant - JQAGCP QUALITY ASSURANCE
  • Martina Duevel, Systems Excellence Project Leader - BAYER
  • Paul Fenton, President and CEO - MONTRIUM
  • Lucy Hampshire, Director, Medicines Quality Organisation - International - ELI LILLY
  • Martin Hausten, Head of Global Documentation Quality Centre EU - BOEHRINGER INGELHEIM
  • Renee Heuser, Director, Clinical Documentation Center - ABBVIE
  • Etienne Hinton, Clinical Trials Coordinator - DUKE UNIVERSITY MEDICAL CENTER
  • Michelle Ingraham, Manager, Information Governance and Compliance - PPD
  • Andreas Jaremo, TMF Global Lead - ASTRAZENECA
  • Wendy Koc, Senior Manager Clinical Compliance - GILEAD SCIENCES
  • Magalie Lemoine, Trial Master File Governance Office Lead - NOVARTIS
  • Adam Lenart, Senior Big Data Science - NOVO NORDISK
  • James Martin, Director, TMF Operations - CDS, SYNEOS HEALTH
  • Mick Mullane, Innovation Lead - NATIONAL INSTITUTE OF HEALTH RESEARCH
  • Suzanne Murray, VP, Quality - AGIOS PHARMACEUTICAL
  • Stephen Nabarro, Head of Clinical Operations and Data Management - CANCER RESEARCH UK
  • Patricia Pengelly, RDQA Area Head, EEMEA - ABBVIE
  • Helen Price, Senior Director - Head of TMF Solutions - Quality Management - IQVIA
  • Eldin Rammell, Executive Director - HSRAA, Director, Expert Solutions - PHLEXGLOBAL
  • Karen Roy, Chief Strategy Officer - PHLEXGLOBAL
  • Barry Sacks, Chief Technology Officer - PHLEXGLOBAL
  • Vittoria Sparacio, Head, Clinical Documentation Operations, R&D Projects, Clinical Platforms and Sciences - GLAXOSMITHKLINE
  • Carina Teufel, Global Document Specialist - BOEHRINGER INGELHEIM
  • Jamie Toth, Director and Head of TMF Operations - DAIICHI SANKYO
  • Wendy Trimboli, Director, Head of TMF Management and Compliance - EISAI
  • Jane Twitchen, Associate Director, Global Clinical Operations - BIOGEN
  • Jason Weinstein, Business Lead and Manager, eTMF - REGENERON
  • Matthias Wittig, TMF Business Lead Consultant - ARCONDIS
Pre-Conference Workshops - Tuesday 1 October

Conference Day One - Wednesday 2 October

Conference Day Two - Thursday 3 October

Venue

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

To make reservations, guests can call +44 0207 722 7711 and request the group code 'M3M' or 'ExL's 8th EU TMF Summit'. To make reservations online Click Here
 
The group rate is available until August 19. Please book your room early, as rooms available at this rate are limited.