Forum on Global Publication Planning & Clinical Trial Registries

Day 1 Programme, 11-Jun-2012

Summary : The conference starts with registration,discuss on evaluate challenges surrounding early disclosure reporting and the subsequent publication.

08:30 AM  -  08:45 AM
Conference Registration & Continental Breakfast
John P. Gonzalez, Director

08:45 AM  -  09:30 AM
Panel Examine the Evolving Regulations and Requirements for Posting and Reporting Data - Country Specific Nuances
Merete Jrgensen, Director for Global Clinical Registry, Novo Nordisk A/S (Denmark)

09:30 AM  -  10:15 AM
Assess Developments, Compare Functionality and Clarify Regulations of Multiple Registries Worldwide
Hanns-Georg Leimer, Head of Processes

10:15 AM  -  10:45 AM
Networking and Refreshment Break

10:45 AM  -  11:30 AM
Legal Implications of Global Transparency Reporting
Catherine Arnaudeau-Bgard , Director & Global Head, Global Medical Affairs UCB (Belgium)

11:30 AM  -  12:15 PM
A. Europe Considerations
Russell Traynor, Executive Committee, ISMPP

12:15 PM  -  13:00 PM
B. Asia-Pacific Considerations
Karen Woolley, CEO, ProScribe Medical Communications

13:00 PM  -  14:15 PM
Networking Luncheon

14:15 PM  -  15:00 PM
Case Study The Integration of Clinical Trial and Publication Planning Teams to Maintain Consistency for Results Reporting
Susan Scott, Director, Publications and Communications Ipsen

15:00 PM  -  15:45 PM
Case Study Cross-Functional Collaboration to Optimise Results Disclosure on ClinicalTrials.gov

15:45 PM  -  16:15 PM
Networking and Refreshment Break

16:15 PM  -  17:00 PM
Assess Internal Coordination for Data Consistency
Thomas Wicks, Senior Manager , Deloitte Analytics LLC (United States)

17:00 PM  -  17:45 PM
Evaluate Challenges Surrounding Early Disclosure Reporting and the Subsequent Publication

17:45 PM  -  18:45 PM
Close of Day One

17:45 PM  -  18:45 PM
Networking, Wine and Cheese Reception

Day 2 Programme, 12-Jun-2012

Summary : The conference starts with registration,discuss on the identify global clinical trial reporting responsibilities.

07:30 AM  -  08:00 AM
Continental Breakfast

08:00 AM  -  08:15 AM
Chairperson's Review of Day One
Tatjana Poplazarova, Head of Medical Governance, GlaxoSmithKline Biologicals (Belgium)

08:15 AM  -  08:45 AM
Editor Perspective Understand Issues Identified by Editors and How Medical Writing can be Improved
Stuart Spencer, Executive Editor , The Lancet (United Kingdom)

08:45 AM  -  09:30 AM
Challenges of Publication Planning in an Increasingly Regulated Industry
Lucy Hyatt, Senior Manager, International Scientific Publications

09:30 AM  -  10:14 AM
Assess the Integrity of Authorship Agreements to Prohibit Ghost Writing and Ensure Results are Published Objectively and Accurately
John P. Gonzalez, Director of Publications Policy, R&D Clinical Development

10:15 AM  -  10:45 AM
Networking and Refreshment Break

10:45 AM  -  11:44 AM
Panel Editor Panel - Understand Publication Responsibilities and Challenges from the Medical Writing Community
Keith Veitch, Head of Global Publications , Novartis (Netherlands)

11:45 AM  -  12:30 PM
Case Study A Closer Look at GSK and Its Internet-Based Clinical Study Initiatives
Tatjana Poplazarova, Head of Medical Governance, GlaxoSmithKline Biologicals (Belgium)

12:30 PM  -  13:45 PM
Networking Luncheon

13:45 PM  -  14:30 PM
Case Study Evaluate the Efforts of Sanofi to Automate Public Disclosure
Jean-Philippe Keunebroek, R&D Regulatory Affairs, Global Regulatory Affairs Sanofi (France)

14:30 PM  -  15:30 PM
Roundtable A For Publication Planning Professionals: Recognise the Individual Needs and Contexts of Global Market Places

14:30 PM  -  15:30 PM
Roundtable B For Clinical Trial Professionals: Identify Global Clinical Trial Reporting Responsibilities
Merete Jorgensen, Director for Global Clinical Registry , Novo Nordisk A/S (Denmark)

15:30 PM  -  00:00 AM
Close of Conference