Past event: European Trial Master File Summit

Europe's Select TMF Event - Superior Networking and Dissemination of Successful Practices

This summit continues to grow in popularity and renown among discerning TMF professionals. Pioneering and illustrious leaders of the 7th European TMF Summit constitute a high calibre speaking faculty who are eager to share their insights and experiences.

The synergy of each year's cohort amplifies the compelling and meaningful content that this event is known for. The rich discourse and participatory character of the case studies, interactive workshops, panels and expository sessions ensure that you will to return to work prepared, equipped and confident your ability to realize continuous improvement;

The quality and immediate relevance of topics are assured every year by the certainty that this event is by and for TMF professionals. And through the addition of a second track, participants may customise their own learning and networking experience.


EVENT HIGHLIGHTS

  • Augmented Professional Development
  • Preconference Workshops
  • Self-Tailored Experience - Two Tracks
  • Unparalleled Networking
  • 130+ Participants
  • High Percentage of Sponsor-Led Sessions
  • Candor and Sharing Among Disparate Stakeholders
  • Selected Case Studies and Panels


2018 KEY TAKEAWAYS

  • Conduct trial oversight using tailored metrics and tools and proven methods
  • Manifest continuous improvement by streamlining processes without compromising Quality
  • Ensure Quality and data integrity using QC that are risk-based
  • Maintain inspection readiness through a TMF management plan informed by inspection trends
  • Work with internal stakeholders from outside of the clinical function and with CROs


Who Should Attend

This conference is designed for representatives from pharmaceutical, biotech, medical device companies as well as 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

  • Catarina Bergman, TMF Adoption Lead, ASTRAZENECA
  • Mieke Borgs, Global Head Clinical Document Governance and Management, GDO Trial Management, NOVARTIS
  • Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY, a QUINTILESIMS COMPANY
  • Francis P Crawley, Executive Director, GCPA & SIDCER
  • Martina Duevel, Systems Excellence Project Leader, BAYER
  • Tonya Edison, Director, Trial Capabilities, Trial Master File, Records Management, Metrics, ELI LILLY
  • Paul Fenton, President and CEO, MONTRIUM
  • Andrew Fisher, Lead Senior GCP Inspector, MHRA
  • Lucy Hampshire, Director, Medicines Quality Organisation - Europe, ELI LILLY
  • Martin Hausten, Team Lead Global Document Specialist, Head of Global Document Quality Content, BOEHRINGER INGELHEIM
  • Alison Hussain, Manager - TMF Management and Compliance, Global Regulatory Services and Operations, EISAI
  • Wendy Koc, Senior Manager Clinical Compliance, GILEAD SCIENCES
  • Ute Kohlhaas, Head of CPM Gynecology, BAYER
  • Gergana Koutsarova, Global TMF Process Owner, ASTRAZENECA
  • Meredith Lafond-Phesans, TMF QC Operational Manager, SANOFI PASTEUR
  • Anna Szaff Lundsgaard, Senior Clinical Trial Administrator, NOVO NORDISK
  • Gerard Lynch, Associate Director, GCO, BIOGEN
  • Maria Nymann Jensen, Competency Development Professional, NOVO NORDISK
  • Eldin Rammell, Managing Director, RAMMELL CONSULTING
  • Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
  • Barry Sacks, Chief Technology Officer, PHLEXGLOBAL
  • Jenny Savva, Clinical Operations Manager, CANCER RESEARCH UK
  • Annebeth Sio Jensen, Principal Competency Development Specialist, NOVO NORDISK
  • Vittoria Sparacio, Head, Clinical Documentation Operations GSK Pharma R&D Projects, Clinical Platforms and Sciences,  GLAXOSMITHKLINE
  • Perry Steinberg, Regulated Content Management - General Manager and Product Leader, MEDIDATA
  • Paul Stewart, Associate Director, Clinical Quality & Compliance, MEDIMMUNE
  • Jamie Toth, Head of TMF Operations, DAIICHI SANKYO
  • Wendy Trimboli, Head of TMF Process Management and QC, ESAI
  • Jane Twitchen, Associate Director, Global Clinical Operations, BIOGEN
  • Anne-Mette Varney, Principal Competency Development Specialist, NOVO NORDISK

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


Pre-Conference Workshops - Monday, 15 October 2018

Conference Day One - Tuesday, 16 October 2018

Conference Day Two - Wednesday, 17 October 2018

Venue

The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.

Venue

Hilton London Bankside
2-8 Great Suffolk St.
London, England SE1 0UG

Hilton London Bankside represents the next generation of design-led Hilton Hotels. Ideally located in the heart of Bankside and only a stone's throw away from some of London's must-visit landmarks including Tate Modern, Borough Market and The Shard.

To make reservations, guests can call +44-20-36675600 and use the code GEXLA to receive the negotiated rate. To make reservations online Click Here

The group rate is available until 24 September 2018. Please book your room early, as rooms available at this rate are limited.
Event details
Organizer : ExL
Event type : Conference
Reference : ASDE-18946