5th Trial Master File Summit – 5th Trial Master File Summit

ExL Pharma’s 5th Trial Master File Summit, taking place on January 20-22, 2016 at the Westin Arlington Gateway in Virginia, 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.

Featured Speakers


  • 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

Who Should Attend

This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas:

  • Clinical Operations
  • Document Management
  • Regulatory Affairs
  • TMF and eTMF
  • Data Management
  • Clinical Document Coordination
  • Document and Record Specializations
  • Clinical Development
  • Regulatory Operations
  • Essential Document Management
  • Quality Assurance and Operations
  • Knowledge Management
  • Global Planning and Standards
  • Strategic Clinical Operations and Planning
  • Clinical Trial Management
  • Quality Management
  • Informatics
  • Clinical Information Technology

This conference is also of interest to:

  • TMF Service Providers
  • Data/Records Management Vendors
  • CROs
  • Consultants