9th Annual Biomarkers Congress
4th Annual Clinical Forum 2010
Lisboa Congress Center

Praça das Industrias, Lisboa
http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=22350&eventType=Meeting
 Dear Friends and Colleagues, We have great pleasure in inviting you to
   participate in the DIA 4th Annual Clinical Forum ‘Navigating the
   Future’ from October 11-13 2010, in Lisbon, Portugal. From the 14th to
   17th century Portugal led the Old World in navigating to seek new and
   exciting expansion opportunities. Emerging from a global recession is
   an opportune time to contemplate how strategically and operationally
   we can successfully navigate clinical development through 2010 and
   beyond. The 1755 Lisbon earthquake, a catastrophic human disaster
   throughout Portugal and Northern Africa was one of the key drivers of
   the philosophy of enlightenment, thinking beyond Man and God. We
   invite you to join us to seek enlightenment in the best strategies,
   processes and technologies to navigate clinical development through
   the first half of the 21st century. In March 2010 you will receive a
   Call for Abstracts flyer with information on how you can become a
   speaker or session chair for the Clinical Forum 2010.


   Praça das Industrias , Lisboa, 1300-307 , Portugal

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Schedule of Presentations:

Monday, October 11, 2010
09:00:00 THE FUTURE OF THE REGULATORY CLINICAL TRIALS ENVIRONMENT Ingrid Klingmann
09:05:00 The Clinical Trial Authorisation Process Wolfgang R. Eglmeier
09:30:00 Ethical Review and Risk-based Approach Ingrid Klingmann
10:00:00 Safety Reporting Monika M. Pietrek
14:00:00 Session 1 : CLINICAL STANDARDS Pierre-Yves Lastic
14:05:00 From Protocol Design to Final Reporting: CDISC Implementation Richard Young
14:20:00 NCI, Common Terminology Criteria for Adverse Events Revision Project and MedDRA Compliance Tomas Moraleda
14:30:00 EFFICIENT COLLABORATION WITH CLINICAL SITE NETWORKS Wolfgang R. Eglmeier
14:40:00 Clinical research networks, are they in tune with Sponsors needs? Ana Filipa Bernardo
14:50:00 Are Clinical Research Networks Interested in the Performance of Industry-sponsored Clinical Trials? Andrew Rose
15:00:00 Should Sponsors Invest in Initiation of more Sites or in Selected High Performance Sites? Wolfgang R. Eglmeier
15:10:00 QUALITY ASSURANCE RELATED TO CLINICAL TRIAL SAFETY Margaret Ann Walters
15:15:00 Vendor Agreements for Pharmacovigilance - Experience and exceptions Helena M. Van den Dungen
15:30:00 What do we need to consider for the Qualification of Data Safety Monitoring Board or Safety Advisory Board Members? Monika M. Pietrek
15:45:00 Does the EU QPPV have any Role in Clinical Trial Safety? What do regulators expect? Margaret Ann Walters
16:00:00 Session 2 : CLINICAL DATA WAREHOUSING IN THE AGE OF EDC Peter Stokman
16:05:00 Integrated Subject Data Martin Giblin
16:30:00 Data Warehousing for the Reporting and Management of Clinical Data Robert Ellison
16:45:00 Practical Experiences Transferring Data from EDC to Data Warehouses Andrew Newbigging
17:00:00 Single Version of Truth: Reconciling disparate/conflicting safety/AE data George Laszlo
17:30:00 SIAC Networking Reception in the Exhibition Hall
Tuesday, October 12, 2010
07:30:00 Welcome Coffee and Registration
09:00:00 Session 3 : TECHNOLOGY/QUALITY Nick Lucas
09:30:00 A Look into the Future: A pragmatic approach to IT tools that can help Pharma companies manage EDC properly and ensure best data quality and practices Massimo Raineri
09:45:00 Automatic Tracking of “Medical Affairs Trials” by Merck Serono Vanessa Bohling
10:00:00 Scaling Electronic Health Record (EHR) in Clinical Trials: The operational requirements Joseph S. Anderson
10:30:00 Coffee Break in the Exhibition Hall
11:00:00 Session 4 : RESOURCING FOR CLINICAL DATA MANAGEMENT Julianne Hull
11:05:00 Functional Service Providers: Overcoming the 18-Month Tipping Point Theo Erasmus
11:30:00 Data Managers - The next generation Gail Kniveton
12:00:00 Data Management Evolution - Our north Star journey continues Linda Talley
12:30:00 Lunch in the Exhibition Hall
14:00:00 Session 5 : Plenary Session
15:30:00 Coffee Break in the Exhibition Hall
16:00:00 Session 6 : REGULATORY COMPLIANCE Mette Mackeprang Bruhn
16:05:00 Site eArchive Logistics Gregory D. Gogates
16:30:00 Electronic Regulatory Submission Development and the Impact on the Sponsor’s Organisation – Retooling R&D for ERS Peter M. Lassoff
17:00:00 Regulatory Inspection Readiness Frances E. Nolan
17:30:00 Networking Reception in the Exhibition Hall
18:30:00 Networking Buffet Dinner at the Congress Centre
Wednesday, October 13, 2010
08:00:00 Welcome Coffee and Registration
09:00:00 Session 7 : eCLINICAL FOR INVESTIGATIONAL SITES AND FOR CLINICAL DATA MANAGERS Julianne Hull
09:05:00 Revisiting the eClinical Paradigm: Investigational Site site perspectives on clinical trial information systems Richard Perkins
09:30:00 Global Trends in Clinical Software, Services and Infrastructure - An industry survey Kevin F Shea
10:00:00 Panel Session
10:30:00 Coffee Break in the Exhibition Hall
11:00:00 Session 8 : TACTICS TO REDUCE WASTEFULNESS OF FUTURE CLINICAL OPERATIONS Dennis N Joseph
11:05:00 Facilitating Patient Selection through Independent Review of Inclusion/Exclusion Criteria Drew Kilpatrick
11:30:00 Vendor Access to the eTMF to Optimise Clinical Operations Rasmus Nelund
12:00:00 Utilising Metrics to Optimise Clinical Trial Planning and Management Richard J. Piazza
12:30:00 Conference Ends
4th Annual Pharma R&D Asia Congress
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