For Immediate Release

DIA IN EUROPE TO HOST 10TH CONFERENCE ON ELECTRONIC DOCUMENT MANAGEMENT

BASEL, SWITZERLAND—3 NOVEMBER 2009—The Drug Information Association (DIA) in Europe will host the 10th Conference on European Electronic Document Management (EDM) from December 3-4, 2009 in Vienna, Austria.

How happy are we with our EDM systems? Are we getting all the benefits out of our elaborate software packages? If not, what can we do to unleash the full power of these tools to serve end-to-end processes, in a highly regulated environment? The 10th Conference on European Document Management (EDM) will answer these questions and address the latest developments in EDM. Session topics will include:

• Operating and Implementing EDMS Technologies

• Leveraging Technologies for Quality and Efficiency

• Best Practices in Managing the Document Lifecycle

• Using Metadata Standards in the Use and Re-Use of Regulatory Information

• XML Developments and XML Implementation

• Electronic Archiving Strategies for Submission Documentation

• Electronic Trial Master File Management

• Preparing eCTD Filings for Different European Procedures

• 2009 into 2010 - Current Agency Experience and Requirements

• Current and Future Submission Formats

A special Meet the Regulators session will allow attendees to ask questions of regulatory representatives, including:

• Christa Wirthumer-Hoche, Head, Unit for Marketing Authorization and Life-cycle Management of Medical Products, AGES PharmMed, Austria

• Timothy Buxton, Head of Sector, Project Management, EMEA, EUStan A. Van Belkum, Programme Manager, Medicines Evaluation Board, The Netherlands

• Gary Gensinger, Director, Regulatory Review Support Staff, CDER, FDA, USA

• Stephan P. Jaermann, Business Project Manager, Swissmedic, Switzerland

Full-day pre-conference tutorials on December 2 include:

• eSubmission – A Highlight of the Differences

• eTMF – Migrating from Paper Trial Master Files to Electronic

• A Document Management Practicum: Ideas to Improve and Enhance your Journey into the Future

Stan A. Van Belkum, Programme Manager, Medicines Evaluation Board, The Netherlands, will deliver the keynote address.

“Many companies in the pharmaceutical industry now have well-established EDM and publishing systems and many more are gearing up to face new mandatory requirements for electronic Common Technical Document (eCTD) filing, says Programme Co-Chair Melanie J. Clare, Global Head, Clinical Document Management & Publishing, GlaxoSmithKline, UK. “While the focus has been on preparation of eCTD filings over the past years the life-cycle management aspects and the accessibility of the information throughout the retention time will now receive attention.”

Register for 10th Conference on European Electronic Document Management (EDM).

About the Drug Information Association (DIA)
The Drug Information Association (DIA) is a nonprofit, multidisciplinary, global association that serves more than 30,000 professionals in the biopharmaceutical and related industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral forum for the exchange of information critical to the development and lifecycle management of biopharmaceutical and related products.. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based board of directors and executive management team. For more information, visit www.diahome.org or call DIA in Europe on +41 61 225 51 51.

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Contact : Katie McKinnon
DIA European Office
+41 61 225 51 36
Katie.McKinnon@diaeurope.org

Joe Krasowski
DIA
+1-215-293-5812
Joe.Krasowski@diahome.org