9th Annual Biomarkers Congress
11th Conference on European Electronic Document Management
Hotel Le Meridien
1 Promenade Des Anglais
Nice, Provence-Alpes-Côte d'Azur
http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23224&eventType=Meeting
 In an evolutionary environment, it seems that every time one overcomes a
   hurdle one discovers a whole new world to conquer. Similarly, in EDM
   we are discovering new frontiers. While on the regulatory submissions
   front, CTD and eCTD are now well known and understood and thousands of
   submissions are managed as eCTDs within stable EDM technologies, new
   horizons unfold ahead of us: Electronic gateways and advanced
   submission standards such as CDISC and RPS that extend the
   capabilities and flexibility of information exchange, new approaches
   for Enterprise Information Management, simpler and more affordable
   tools allowing compliant EDM for small corporations, collaborative and
   component-based authoring and new, powerful user interfaces are only
   some of the emerging novelties. Additionally, information sharing in
   the public domain has reached previously unthinkable levels and new
   techniques of information management are needed to handle both the
   disclosure and analysis of this new information


   1 Promenade Des Anglais , Nice, Provence-Alpes-Côte d'Azur, F- 06046
   , France

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Schedule of Presentations:

Wednesday, December 1, 2010
07:00:00 Registration
Thursday, December 2, 2010
09:00:00 START OF CONFERENCE
09:05:00 WELCOME AND INTRODUCTION Melanie J. Clare
09:10:00 WELCOME AND INTRODUCTION Dimitri Stamatiadis
09:30:00 Data Management and Integration Strategies that Target Present Needs and Future Challenges John P. Farrell, Morwenna Gould
10:00:00 The Evolution of Submission Standards from the Perspectives of EMA, Industry and Vendor Geoffrey Williams
10:30:00 Break
11:00:00 VALIDATING THE INFORMATION ENVIRONMENT Dimitri Stamatiadis
11:05:00 Risk-based Validation, a practial experience Frank Schalldach
11:30:00 Risk-based Validation, a practical experience Rene Kasan
11:45:00 The Efficient Validation of EDM and Submission Mangement Thomas Staedte
12:00:00 Update: Status of eSignature Use in the EU - The view from industry
12:10:00 eTMF IMPLEMENTATION Karen Jane Redding
12:20:00 The Outsourced Implementation of a Global eTMF Jane Margaret Twitchen
12:30:00 You Have Your eTMF Ready - Now what? Martin Lillis
12:40:00 eCTD Meets eTMF Murat Hamzakadi
12:45:00 Lunch
14:00:00 eCTD Hans van Bruggen
14:15:00 A Case Study of Business Technology Continuity: Transition of in-house eCTD publishing systems to a hosted web environment during times of risk and change Christian A. Buckley
14:30:00 Implementation of eCTD Tuned Business Processes Pierre Geruzet
14:45:00 Realising eCTD Capability with External Providers Sibylle Teuchmann
15:00:00 BUILDING A COMPLIANT TMF PROCESS Eldin Rammell
15:10:00 Redefining the Trial Master File Ivan Walrath
15:20:00 The role of the DIA Reference Model in Defining TMF Content Martin Thorley
15:30:00 A Process-based Approach to Metadata Models Eldin Rammell
16:00:00 OPERATING WITH SCIENTIFIC CONTENT Melanie J. Clare
16:05:00 eARCHIVING/RECORDS MANAGEMENT Anita Paul
16:15:00 Compliant eArchiving - Lessons learnt Siegfried Schmitt
16:30:00 "EDMS in The Cloud" - Opportunities and considerations for smaall and mid-size pharma companies
17:00:00 Successfully Applying Standards to Preserve Information Assets Long-term
Friday, December 3, 2010
08:30:00 DIA REFERENCE MODELS Steve Scribner
10:00:00 Break
10:30:00 EMERGING MARKET SESSION Joris Kampmeijer
10:35:00 The CTD, eCTD and ACTD in Southeast Harv Martens
11:00:00 Overcoming EDM Challenges when Repurposing EU and US Submission Documentation for Use in the Latin American Region Michelle A. Perez
12:00:00 Lunch
13:30:00 DOCUMENT AND SUBMISSION MANAGEMENT Thomas Altenwerth
13:45:00 More Than Just an Envelope: RPS progress report Joel Finkle
14:00:00 Business Process Management and Master Data Management Erick Jacques Gaussens
15:00:00 eDMS/eCTD in a Generic Pharmaceutical Company Tom Manussen
15:30:00 AGENCY/REGULATORY SESSION Hans van Bruggen
4th Annual Pharma R&D Asia Congress
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