QUMAS To Host Webinar On Expediting New Drug Application Processes By Automating Submissions And Content Management
Drug Developer Neurogen to Share How it Plans to Use QUMAS Technology for Content and Publishing
QUMAS, a leading provider of quality management and regulatory affairs solutions, today announced that it will host a Webinar on June 5, 2007 at 2:00 p.m. EDT / 11:00 a.m. PDT on how its customer Neurogen is implementing the QUMAS R&D Suite™ to automate content and submissions management to expedite the new drug application process.
Life sciences organizations today are challenged to maintain product quality, productivity, ROI and compliance. To be competitive, biopharmaceutical companies must streamline their product lifecycles, including IND and NDA approvals, as well as validation of the production process.
In this Webinar, participants will hear about how Neurogen plans to meet these challenges by using the QUMAS R&D Suite, an all-inclusive content and publishing system, for its content management needs for Nonclinical, Clinical, CMC, Safety, Quality and Regulatory groups.
The QUMAS R&D Suite provides Neurogen and other life sciences companies with an automated solution to expedite the new drug application process with better quality submissions, fewer iterations, shorter review and approval cycles, as well as reduced costs associated with managing the solution over time.
The 45-minute presentation will focus on the following topics:
- Evolving paper-based and decentralized document filing systems
- What to look for in an automated solution to expedite regulatory filings
- Benefits of a fully integrated content management and submission management solution
- Why a secure and controlled document collaboration system is an essential requirement
- Expectations for higher quality and more efficient results for today and tomorrow
Featured speakers at the Webinar include:
- Joanne Malia, computer systems validation manager, Neurogen
- Al Starbard, senior director, Information Technology, Neurogen
- Patricia Santos-Serrao, RAC, regulatory advisor, QUMAS
To register for the Webinar, visit: http://WWW.QUMAS.COM/news-events/register-webinar.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.
About Neurogen
Neurogen Corporation is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical need, including insomnia, obesity, pain, Parkinson's disease, restless legs syndrome (RLS), and depression. Neurogen conducts its research and development independently and, when advantageous, collaborates with world-class pharmaceutical companies to access additional resources and expertise.
The information in this press release contains certain forward-looking statements, made pursuant to applicable securities laws, which involve risks and uncertainties as detailed from time to time in Neurogen's SEC filings, including its most recent 10-K. Such forward-looking statements relate to activities, events or developments that Neurogen believes, expects or anticipates will occur in the future and include, but are not limited to, earnings estimates, statements that are not historical facts relating to Neurogen's future financial performance, its growth and business expansion, its financing plans, the timing and occurrence of anticipated clinical trials, and potential collaborations or extensions of existing collaborations. These statements are based on certain assumptions made by Neurogen based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Actual results may differ materially from those expressed or implied by such forward-looking statements as a result of various factors, including, but not limited to, risks associated with the inherent uncertainty of drug research and development, difficulties or delays in development, testing, regulatory approval, production and marketing of any of Neurogen's drug candidates, adverse side effects or inadequate therapeutic efficacy or pharmacokinetic properties of Neurogen's drug candidates or other properties of drug candidates which could make them unattractive for commercialization, advancement of competitive products, dependence on corporate partners, Neurogen's ability to retain key employees, sufficiency of cash to fund Neurogen's planned operations and patent, product liability and third party reimbursement risks associated with the pharmaceutical industry. Although Neurogen believes that its expectations are based on reasonable assumptions, it can give no assurance that the anticipated results will occur. For such statements, Neurogen claims the protection of applicable laws. Future results may also differ from previously reported results. For example, positive results or safety and tolerability in one clinical study provides no assurance that this will be true in future studies. Forward-looking statements represent the judgment of Neurogen's management as of the date of this release and Neurogen disclaims any intent and does not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required under applicable law.