Session Information
2009 BIO International Convention
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Navigating the New Registry Requirements: Implications for Industry
Track : Clinical Research/Clinical Trials
Program Code: 3244
Date: Thursday, May 21, 2009
Time: 4:00 PM to 5:30 PM  EST
Location: B311
SPEAKER (S):
Elizabeth Gobeil, JD, Thompson Hine LLP
Shannon Klinger, Solvay Pharmaceuticals, Inc
Mark Nance, Esq, GE Medical Diagnostics
Linda Nyari, JD, PATH
Theresa Toigo, RPh, U.S. Food and Drug Administration
Description
Recent changes to the U.S.'' clinical trial registry and results database requirements differ from existing U.S. and international government and professional standards. Through the use of interactive exercises, participants will consider the requirements'' impact on clinical research sponsors'' intellectual property, compliance systems, promotional activities,ability to defend against claims and other areas.

• Adapt your business by understanding how the new registry and results database requirements differ from pre-existing U.S. and international standards
• Realize the impact of the changes on your bottom line, including your ability to protect your intellectual property from disclosure, to gain market intelligence, to communicate about your products, to manage adverse event disclosures, to spur or defend against litigation and to ensure compliance
• Manage and/or limit risks associated with these requirements by utilizing contractual and compliance strategies


Audio Synchronized to PowerPoint
(Code: 3244)
  
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