PRZOOM - /newswire/ -
Whippany, NJ, United States, 2007/03/09 - Series includes quarterly webinars, reports & analyses covering the global regulatory landscape and practical approaches and best practices in the transition to eCTD.
ISI, a software and services provider to the Life Sciences industry, announced today that they will offer a multi-session Webinar series and industry report program called Sentinel, to help global pharmaceutical organizations transition to eCTD. ISI’s first one-hour webinar “The Next Frontier in Electronic Submissions – Making the Transition to eCTD” is scheduled for March 27, 2007 at 11 AM EST.
The FDA’s Center for Drug Evaluation and Research recently announced the recall of the 1999 eNDA, eANDA, and Annual Reports for eNDA and eANDA electronic submission guidance documents. These documents will be removed from the electronic submission docket on December 31, 2007. This action was taken to reaffirm the FDA’s commitment and preference of the Electronic Common Technical Document (eCTD) format for electronic submissions. Several European agencies have already made the commitment to electronic regulatory submissions while Europe as a whole is targeting 2009 for all regulatory authorities to have the capability to accept eCTDs.
During this webinar, ISI will provide an overview of FDA and ICH guidance, as well as present high-level strategies for navigating the submission and review processes, followed by a demo of the company’s flagship eSubmissions products, eCTDXPress and ISIPublisher. Participants will also witness a major breakthrough in regulatory software – the ISI Solutions Platform. The ISI Solutions Platform, which leverages Microsoft’s .NET architecture, is a flexible foundation that provides custom solutions by accommodating changes in business requirements, differing regional regulatory requirements, or a company’s market needs. The Solutions Platform can support any size company with solutions that scale as the business grows, or as its submissions environment becomes more complex, with no need to invest in new technologies every time a change takes place.
As an additional effort in supporting their commitment to keep their clients informed on industry guidance and regulatory compliance, ISI is also offering eCTDReadiness Workshops on April 12-13, and May 7-8. Designed for Life Science professionals, the eCTD Readiness Workshop educates participants on the basics and details of the CTD and eCTD.
About Image Solutions, Inc. (ISI)
Founded in 1992, Image Solutions, Inc (imagesolutions.com) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firm to deliver electronic submissions to the industry and since has delivered more than 600 electronic submissions. ISI serves the top 50 pharmaceutical and biotech organizations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia.