Event Details
- Summit
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This event has been completed
4th European Trial Master File Summit - October 12, 2015 - October 13, 2015
- Radisson Blu Edwardian Bloomsbury Street
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London, United Kingdom
- Introduction
- A Trial Master File (TMF) is a collection of hundreds of thousands of pages of clinical documents compiled to prove that good clinical practice (GCP) is being met. Because of the importance of a TMF, organizations must understand how to efficiently develop, manage and create a TMF process that ensures high quality, inspection readiness and operational efficiency. In order to accomplish this, professionals involved in the TMF must first create a structure for collection, monitoring and performing quality checks regardless of whether the trial is conducted.
Now in its fourth year, European Trial Master File Summit— will continue to provide an educational platform for professionals to explore best practices to enhance their eTMF or paper TMF platform in order to increase quality and ensure inspection readiness.
Top Reasons to Attend:
A keynote presentation from the MHRA’s senior GCP inspector, Andy Fisher, who will be discussing an inspector’s expectation of TMF accessibility and availability
A interactive pre-conference workshop on how to develop and enhance your TMF process and structure to meet business, technology and regulatory needs
6+ case study presentations from representatives of Actelion, Polyphor, Boehringer Ingelheim, Leo, Phlexglobal and other organizations
Engaging panel sessions on enhancing the collection of eISF and managing internal and external email correspondence
9+ hours of networking with the largest community of TMF professionals
14+ hours of educational sessions that will provide you with best practices, lessons learned and case studies - Useful Links
- Reference link 1
- About Organiser
- ExL Events
- E: ering@exlevents.com
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