01th - 03th October, 2019, London (UK)

8th European Trial Master File Summit

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. 

CONFERENCE INTRODUCTION:

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

This year’s programme is expanded and include two tracks on each day, so participants may better tailor their own learning and networking experiences.

WHO SHOULD ATTEND:

  • 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
  • eTMF System Service Providers
  • Data/Records Management Vendors
  • Clinical Research Organisations
  • Paper and Electronic Archiving Solution Providers

2019 UPGRADES

✓ 15 Case Studies — Replicable Practices: Learn Lessons the Easy Way

✓ Inspections Trends Revealed — Workshop to Compare Inspection Experiences

✓ 35+ Speakers —Get Actionable Insights From TMF Leaders and Stakeholders

✓ Hot Topics — Oversight, Automation, Risk-Based Strategies, Artificial Intelligence, and More

✓ 10+ Hours of Networking With 150 Participants

✓ Diverse Perspectives — Presentations and Panels Featuring CRO and Site Points of View

✓ Integration — Learn Practical Engagement Tips From Multiple Functions

✓ Technology — Interoperability, Bots, Automation, Migration, Dashboards, ePRO, eConsent, and More

For more details: https://tmfsummit.com/europe

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