Phlexglobal will sponsor ExL Pharma’s 5th Trial Master File Summit, which will take place from 20-22 January 2016 at the Westin Arlington Gateway in Virginia, US.
The conference will focus on developing, managing and monitoring a TMF process in order to ensure a complete, compliant, high-quality and inspection-ready TMF.
The programme features more than 30 industry professionals representing trial sponsors, CROs and TMF service providers. The agenda will explore key factors that drive successful TMF management, with a focus on enhancing TMF processes and quality.
Expert speakers will cover paper and electronic system strategies to ensure attendees meet all global regulatory requirements in their TMFs.
Phlexglobal’s senior vice-president of Client Solutions will be chairing the conference on Thursday 21 January at 1.15pm.
The case study ‘Map Your Organisations TMF While Keeping Standadisation, Flexibility and Interoperability in Mind’ will be presented.
Visitors can listen to an update on Version 3.0 of the TMF Reference Model. V3 deliverables will be evaluated, including interoperability and presentation, and examples of biotech and large pharma moves to V3 will be analysed.