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Event Details
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  •   Summit  

  • This event has been completed
    5th Trial Master File Summit
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  • January 20, 2016 - January 22, 2016
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  • Westin Arlington Gateway
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  •   Arlington, VA, United States
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  • Introduction  
  • 5th Trial Master File Summit, Focuses on developing, managing and monitoring a TMF process in order to ensure a complete, compliant, high-quality and inspection-ready TMF. The program features more than 30 industry professionals representing trial sponsors, CROs and TMF service providers. The agenda will dive into key factors that drive successful TMF management, with a focus on enhancing your TMF processes and quality. Our expert speakers will cover both paper and electronic system strategies to ensure attendees meet all global regulatory requirements in their TMFs.

    The2016 TMF Summit Features

    20 educational sessions covering all aspects of paper and electronic TMF filings
    6 case study presentations from Amgen, Bayer, BioMarin, Boehringer Ingelheim, Eisai and Janssen
    A TMF workshop for newcomers, which introduces the Trial Master File and the many challenges that TMF professionals face
    A 5-hour interactive TMF training seminar on the keys to successful TMF management
    9+ hours of networking with 175+ TMF professionals An engaging panel session on trends, the preparation of and expectations for a TMF inspection
    14+ hours of educational sessions that will provide you with best practices, lessons learned and case studies
    Updates on the DIA Reference Model Version 3.0, TransCelerate’s eISF and the MCC’s working group 
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  •   Useful Links  
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  • Reference link 1 
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  •  About Organiser
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  • ExL Events 
  • E: info@exlpharma.com
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