MasterControl, Inc., a global provider of quality, audit, and document management software solutions, today announced that one of its experts will speak at Drug Information Association's (DIA) EDM Conference, October 9-11, 2012 at the Hilton Baltimore.
Patricia Santos-Serrao will present "Reconciling the Overlap between the Electronic Document Management (EDM) and Trial Master File (TMF) Reference Models." Santos-Serrao is MasterControl's senior product manager for pharmaceutical, biologics and blood products. Her presentation will review where some of the overlap exists in implementing both the DIA EDM and TMF Reference Models into a document management system, explaining how to eliminate duplication and discussing the pros and cons to implementing both reference models simultaneously instead of incrementally.
Prior to joining MasterControl, Santos-Serrao held the position of manager, global regulatory solutions for QUMAS, where she helped drive the development, sales, marketing and implementation of solutions for the R&D areas of the Pharmaceutical pharmaceutical Industry industry with a particular focus on submission document management for Regulatory regulatory Affairsaffairs, and Clinical Trial Master Files (CTMF) for Clinicalclinical.
Santos-Serrao also worked with Schering-Plough and Boehringer Ingelheim, both in regulatory affairs and clinical departments. She's assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling eCTDs, and other submission format filings worldwide. A graduate of Western Connecticut State University and University of Phoenix, Santos-Serrao holds a Bachelor's of Science degree in Business Administration. She is a member of Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA) and has also earned her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Regulatory Affairs Certification Board (RACB).
DIA provides professionals at all levels and across all disciplines access to timely and authoritative information to advance careers, skills, and innovation in the pharmaceutical, biotechnology, medical device, and related fields. DIA is a neutral forum for facilitating knowledge exchange and collaboration through:
• education and training that provides enterprise-wide solutions across the full spectrum of medical product development;
• meetings, conferences, webinars, online learning, and other events to foster knowledge exchange, collaboration, and networking;
• volunteer leadership opportunities; and
• publications and knowledge resources.
MasterControl, Inc. (mastercontrol.com) produces software solutions that enable companies doing business in regulatory environments 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 clinical management, quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submissions document management, clinical trial management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); or 81 (3) 5422 6665 (Japan)