SALT LAKE CITY, Utah – Feb. 6, 2017 — Patricia Santos-Serrao, RAC, director of clinical and regulatory solutions of MasterControl, will deliver a presentation titled "Bringing TMF and eCTD Together: Is Your TMF Submission Ready?" at the Drug Information Association (DIA) Regulatory Submissions, Information, and Document Management Forum on February 7. The conference will run February 6-8 at the Bethesda North Marriott Hotel and Conference Center in Bethesda, Md.
This presentation will be part of Session 2 Track 3: "EDMS in the 21st Century, Better, Broader, More Flexible." Santos-Serrao will discuss the EDM Reference Model and how it relates to Electronic Common Technical Document (eCTD) and how the Trial Master File (TMF) Reference Model relates to Trial Master Files and the use of TMF artifacts in eCTD submissions. She will also provide tips on how to bring eCTD and TMF together and ensure they are set up to coexist within an Electronic Document Management System (EDMS).
The DIA Regulatory Submissions, Information, and Document Management Forum provides insight into the end-to-end process of managing regulatory submissions and documents. It saw record attendance in 2016, as it serves as the premier place for the discussion of emerging operational standards, best practices, and the processes for submission, creation, and maximum use of regulatory information. The forum continues to explore information generated along the drug development continuum life cycle and alignment to ever evolving regulatory and electronic standards. For more information about the event, visit: http://www.diaglobal.org/en/conference-listing/meetings/2017/02/regulatory-submissions-information-and-document-management
MasterControl Inc. produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle. MasterControl software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management, product lifecycle management, audit management, TMF document management, training management, document control, bill of materials, supplier management, submissions document management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl software provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit www.mastercontrol.com, or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); 81 (3) 5422 6665 (Japan); or +61 (3) 9717 9727 (Australia).