Leading Pharmaceutical and Biotech and Medical Device Companies to Discuss Strategies in Response to the FDA Critical Pathway Initiative
Florham Park, New Jersey – June 12, 2006 – QUMAS, the leading developer of enterprise governance, risk and compliance solutions, announced today Warren Perry, compliance advisor, at QUMAS, will moderate the June 14th BIOCOM breakfast at the La Jolla Marriott, in La Jolla, California at 7:00 a.m. The theme of the breakfast discussion is "The FDA Critical Pathway: Expediting Your Time to Market."
"This panel discussion will look at the Critical Path Initiative and how companies can use it to their advantage," said Perry. "As the cost of bringing new products to markets increases, the need to find ways to speed time to the markets has become even more critical."
Additional participants in the panel include David D'Cruz, vice president, US Regulatory and Clinical Affairs, ResMed, Inc., John F. Wood, senior director, Regulatory Affairs, Amylin Pharmaceuticals, and Laurie Strawn, senior regulatory strategist, Pfizer, Inc. Panelists will share best practices on recent FDA approvals, and the important role the Critical Path Initiative played in the approval process.
The BIOCOM breakfast series is a long-standing tradition within the San Diego Life Sciences community. The series attracts high-caliber, world-class speakers that address topics relevant to the growth and success of the life science industry, including economic trends, financing, technology education and workforce issues.
About QUMAS Compliance Suite
The QUMAS Compliance Suite™ enables life science companies to effectively manage the creation, review, approval and revision of content; efficiently interact with submission management systems; and, ease the process for handling Process Change Control, Adverse Events and other data-centric requirements. The QUMAS web-based application suite enables organisations to consolidate and manage their regulatory compliance requirements through a configurable enterprise software suite. Accessed through the QUMAS Compliance Portal™, which provides a role-based point of access, the Compliance Suite includes two complete software applications -QUMAS DocCompliance™ and QUMAS Process Compliance™.
QUMAS is a leading developer of enterprise compliance management solutions designed to help life sciences organisations 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 organisations to proactively manage their regulated content and processes in a secure and compliant way.
For more information visit http://www.qumas.com.
BIOCOM is a premiere life science industry association representing nearly 500 member companies. The association focuses on initiatives that positively influence the growth of the life science industry, including capital formation, public policy, workforce development, and scientific discovery and development. For more information on BIOCOM or the San Diego regional life sciences community, please visit the organization's Web site at www.biocom.org or contact our offices at 858-455-0300.
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