SOURCE: QUMAS

November 06, 2007 08:00 ET

QUMAS Compliance Expert to Speak at Sixth Annual DIA eCTD Conference

Patricia Santos-Serrão Will Review Effective Strategies and Best Practices for Life Sciences Companies to Transition to an Electronic Document Management System

JERSEY CITY, NJ--(Marketwire - November 6, 2007) - QUMAS, the leading provider of quality management and regulatory affairs solutions, today announced that Patricia Santos-Serrão, a regulatory advisor in the life sciences practice at QUMAS, will speak on "Managing the Successful Transition to eCTD" at the Sixth Annual DIA eCTD Conference: The Future is Now on Thursday, November 15 from 3:30 p.m. to 5 p.m., at the Omni San Diego Hotel in San Diego, California.

Santos-Serrão will discuss the common challenges life sciences companies and regulatory affairs groups face when moving from paper and legacy submissions systems to an electronic document management system. Starting January 1, 2008, the FDA will require that all electronic submissions be filed in an eCTD format. Companies may also file in paper using CTD format for organizing submissions into modules and volumes. In her presentation, Santos-Serrão will specifically address:

--  How to support submission requirements in an efficient and effective
    manner while significantly decreasing workloads
    
--  The top 10 questions each company should ask in order to evaluate
    their readiness to proceed with electronic submissions
    
--  The importance of document management, document granularity, authoring
    templates, document-level publishing, collections of documents and
    submission lifecycle management in the electronic submission process
    

To further illustrate her points, Santos-Serrão will present a case study of a successful transition plan that includes milestones, risks, mitigation strategies and learning outcomes.

Santos-Serrão has spent almost 15 years in the life sciences industry. Starting her career at Schering-Plough in Kenilworth, NJ, and later joining Boehringer Ingelheim Pharmaceutical in Ridgefield, CT, Santos-Serrão held regulatory affairs roles in both companies. Having gained invaluable experience in global submissions in both paper and electronic formats, Santos-Serrão moved into the solutions provider sector joining CDC Solutions, which was later acquired by Liquent. As a business process and regulatory specialist at CDC, she assisted various customers in compiling their worldwide eCTDs and other submission format filings.

The DIA eCTD conference provides the perfect forum for regulatory affairs, operations and document management professionals to get clarification and guidance on what the impending eCTD format deadline means to the life sciences industry as a whole, as well as for companies that submit electronically. QUMAS is currently working with various life sciences organizations including Neurogen, CanReg, SQI Diagnostics and Cytachroma and others who are looking for ways to create guidance-compliant INDs and NDAs in eCTD format. Many organizations are transitioning away from paper-based systems and are looking for an automated software solution that promotes best practices in document and submissions lifecycle management. QUMAS will exhibit and demonstrate its QUMAS R&D Solution, designed to help life sciences companies bring new drugs to market quickly and cost-effectively within a secure and controlled environment.

The QUMAS R&D bundle is an out of the box solution that assists life sciences companies in expediting the new drug application process with better quality submissions, fewer iterations, and shortened review and approval cycles for IND and NDA submissions. The R&D Solution has seen rapid adoption within the industry due to its best-of-breed software for:

--  Regulatory Content Management
--  Submission Management
--  Browser-based Collaboration
--  eCTD (electronic Common Technical Document) Authoring Templates
--  Import/Export Tool
    

For more information on the Sixth Annual DIA eCTD Conference, please visit http://www.qumas.com/news-events/events.asp.

About QUMAS

QUMAS is a leading developer of enterprise compliance management solutions designed to help life sciences organizations meet industry and government standards for 21 CFR Part 11, cGxP, Quality, Regulatory Affairs and Clinical Operations. With over a decade of experience, QUMAS is helping companies accelerate business processes, reduce costs and improve quality. From content lifecycle management, business process and change management to reporting and analysis, QUMAS Compliance Suite is successfully enabling global life science organizations to proactively manage their regulated content and processes in a secure and compliant way.

For more information visit http://www.qumas.com.

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