November 28, 2007 08:00 ET

Patricia Santos-Serrão of QUMAS to Speak at RAPS Regulatory Strategy Forum

Compliance Expert Will Review Document Issues That Are Critical to Designing a Global Regulatory Strategy Document

JERSEY CITY, NJ--(Marketwire - November 28, 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 "The Importance of Document Management When Designing a GRSD" at the Regulatory Affairs Professional Society (RAPS) Regulatory Strategy Forum: Tools for Designing a Global Regulatory Strategy Document (GRSD) on Tuesday, December 4, at the Westin Peachtree Plaza Hotel in Atlanta, Georgia.

RAPS is the leading worldwide member organization devoted to the health product regulatory profession. With more than 11,000 individual members from industry, government, research, clinical and academic organizations in more than 50 countries, RAPS develops professional standards for knowledge, competency and ethics and is the leading source of information on the scope of practice of regulatory professionals and their critical roles in the health sector.

In her discussion, Santos-Serrão will review how a GRSD is a tool crucial in life sciences product development and critical for a business plan given the continually evolving global nature of the industry. Specifically, she will address:

--  The elements of a GRSD, including format, design dossier, common
    technical document (CTD) and risk management tools
--  How to create a GRSD, including standards and tools
--  Regulatory strategies in the context of corporate planning and
--  Executing the regulatory strategy
--  How a GRSD supports regulatory submissions planning

To illustrate her points, Santos-Serrão will cite case studies that demonstrate the correct and incorrect ways to approach a GRSD.

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.

Santos-Serrão is a frequent conference speaker at RAPS and DIA events, is featured on the QUMAS Compliance Room Blog site and is a regular contributor to several industry publications. Her recent articles include "The High Cost of Noncompliance in the US Pharmaceutical Industry," which appeared in the August 2007 issue of Regulatory Affairs Focus, the monthly publication for RAPS members. Also, in the October 2006 issue of Regulatory Affairs Focus, her article "Sound Document Management Lays the Groundwork for Life Sciences Regulatory Publishing" detailed the many benefits of using an electronic document system (EDM).

Santos-Serrão's presentation is ideal for mid- to upper-level regulatory professionals from within the life sciences industry and consulting firms who have submission experience. Upon completion of this program, participants should be able to:

--  Utilize the tools necessary for developing a global regulatory
--  Create a GRSD
--  Explain the role of regulatory strategy in product development and
    lifecycle management
--  Identify and mitigate regulatory risk through management of the plan

For more information on the RAPS Regulatory Strategy Forum, please visit


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

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