This first summit will discuss regulatory compliance using Microsoft Office SharePoint Server 2007 and provide an overview on organizing document management to comply with electronic common technical document (eCTD) and Good Manufacturing Practice (GMP) guidelines. Speakers will include Pfizer, Adlib, Thomas Reuters and ARX. The event is free-of-charge and will be held at IBM House on the Southbank in London, UK on November 24, 2009 from 13:00-18:00. For more details and to register, please visit www.goodproductsltd.com/agenda.htm
The biopharmaceutical sector is challenged with increasingly stringent requirements for the management and submission of electronic documents. The growing need for e-submission capability coupled with more open platform document management options are creating new opportunities for creating value through increased efficiency.
This half-day summit hosted by Good Products is aimed at CEOs, COOs, IT directors, document management specialists and regulatory, quality and clinical managers. The informative session will provide attendees with a detailed overview of current best practices for regulatory compliant document management. Independent industry experts will give presentations on common practices, agency expectations for submission related content and the compliant management of documents and content. The summit will demonstrate how best of breed solutions from different vendors can be integrated effectively to create user-friendly solutions for document management within biopharmaceutical R&D and manufacturing.
"We are delighted to be able to bring together key industry leaders to explore the themes of regulatory compliant document management," comments Keith Williams, CEO, Good Products. "Our EDM summit will incorporate presentations from a wide range of organizations and we believe that the summit will be educational and informative for anyone handling compliant documents."