ISI Webinar: The eCTD as a Springboard to Information Management
For pharmaceutical and life science companies that have raced to meet the deadline for eCTD compliance, the first half of 2008 has provided the opportunity to take stock and assess what they've accomplished. They have used this time to refine regulatory operations and to consider how to best deal with future information management.
While there is still work to be done to adapt fully to the eCTD's requirements, the industry's most cutting-edge companies are now ready to use the eCTD, with its highly structured nature and XML-based standards, to standardize information management across the organization.
Program Content
ISI's Webinar, "The eCTD as a Springboard to Information Management," will examine how life science companies are restructuring current practices and adopting new technology in order to harness the next generation of information management opportunities.
Leading industry consultant Steve Gens will discuss the eCTD and how it relates to larger information management trends. He will share his perspective on how well companies have adapted to the eCTD and identify opportunities where companies can continue to grow and improve. In addition, he will discuss how some companies are building on eCTD success to extend regulatory information into other relevant areas for effective reuse.
ISI expert Adam Sherlock will share insights on information management approaches and will identify potential pitfalls to avoid in creating a long-range information management strategy. He will also give an overview of how XML standards and metadata will play a critical role in breaking down current information silos, allowing companies to efficiently get vital information to those who need it.
ISI Presenter
Adam Sherlock, Director, Business Development, ISI Europe
Adam has 20 years of international marketing, business development, and general management experience in the life science and pharmaceutical industry, specifically in organizations providing IT solutions to this industry in the Clinical Development and Regulatory disciplines.
At ISI, Adam is a key senior member of the EU management team with responsibility for growing business in the UK.
Guest Presenter
Steve Gens, Managing Partner, Gens and Associates, Inc.
As managing partner of Gens and Associates Inc., Steve assists biopharmaceutical companies in improving their organizational and business process effectiveness and technology investment realization. A 20-year industry veteran of large pharma as well as consulting firms, Steve's domain knowledge includes Regulatory Information Management, Clinical Trials Management, Promotional Material, Financial Systems, as well as general strategy formulation, program management, benchmarking services, business case development, and IT strategy.