SALT LAKE CITY, UT — (Marketwired) — 09/13/16 — MasterControl (RAPS booth #301), a leading global provider of enterprise quality management systems (EQMS) and quality consulting services, will offer valuable information at this year–s RAPS– Regulatory Convergence, Sept. 17-20 in San Jose, California, on how to bring trial master files (TMF) and electronic common technical documents (eCTD) together.
MasterControl will be providing insight on ways regulatory affairs can become more involved in defining what and how content is provided for electronic submissions.
Patricia Santos-Serrao, MasterControl director of clinical and regulatory solutions, will be speaking on ways to understand the complexity of TMF and the components that impact regulatory affairs. On Sept. 20 at 12:45-1:30 p.m. PDT, in the demo theater on the exhibit floor, Santos-Serrao will present, “Bringing TMF and eCTD Together: Is Your TMF Submission Ready?” This educational session will provide an action-plan strategy that users can take away to discuss internally with their regulatory and clinical colleagues.
Mapping out an action-plan for identifying which TMF items are required by regulatory affairs and how, when and where this documentation will be made available to regulatory parties can provide greater transparency, increase efficiency and reduce delays for both clinical and regulatory departments within a highly regulated company. In this educational session, Santos-Serrao will provide real-world tips and examples to keep in mind when implementing a TMF. She will also discuss how regulatory affairs can work with their clinical colleagues to identify what TMF artifacts are required for their regulatory submission needs and how best to provide that content in order to expedite the “readiness” of content for your eCTD submissions.
The RAPS– Regulatory Convergence will host more than 1,800 regulatory professionals working in the medical device, pharmaceutical and biotech industries.
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, 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 , or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); 81 (3) 5422 6665 (Japan).
Tim Rush
Springboard5
801-208-1100
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