BOSTON, Oct. 28, 2009 — The Center for Business Intelligence (CBI), a division of Advanstar Communications, is pleased to announce the FDA's participation in a panel on Regulatory Risks, Compliance and Validation at their Inaugural Conference on Clinical Trial Investigator Portals, coming up November 2 – 3, 2009 at the Doubletree Hotel in Philadelphia, PA.
Jonathan Helfgott, Consumer Safety Officer, CDRH Division of Bioresearch Monitoring of the FDA, will join Munther Baara, Director, Clinical Business Systems and Processes, Wyeth Pharmaceuticals; Steve Sweeney, Head, Clinical Operations, Infinity Pharmaceuticals; Diane Nedelkoff, Director, Clinical and Investigator Portal Solutions, InnovoCommerce; Steve Stowers, Business Capability Management, R&D Global Development Informatics, Bristol-Myers Squibb; and Mark Vermette, Senior Director, Global IT CTMS, Quintiles on a panel discussing risk-based validation, 21 CFR Part 11 compliance, two-way discussion boards and implementation versus installation.
Other opportune sessions include:
- Selecting the Development Route for a Clinical Trial Investigator Portal (Dory Rodriguez, MBA, Clinical Systems Lead, Takeda Global Research and Development, Inc. and Bill Dornback, B.S., Clinical Systems Lead, Takeda Global Research and Development, Inc.)
- Survey Investigators and Clinical End Users to Optimize Portal Design (Diane Nedelkoff, Director, Clinical and Investigator Portal Solutions, InnovoCommerce)
- Ensuring Sponsor and Site ROI from Portal Implementation (Alison Shurell, Vice President, Life Sciences Product Marketing, IntraLink)
- Clinical Trials Portals and Data Integration for Patient Recruitment Success (Jaime Cohen, Director, Data Management, TCN e-Systems)
- Employ an Enterprise Clinical Trial Portal to Offer Significant Time and Cost Savings (Lisa La Luna, Senior Vice President, Corporate Business Development and Implementation, ePharmaSolutions)
- Key Decision Points in the Initiation and Deployment of a Global Investigator Portal (Steve Stowers, Business Capability Management, R&D Global Development Informatics, Bristol-Myers Squibb)
- Development of a Clinical Trial Operations and Management (CTOM) Roadmap Strategy – Leverage Portals to Drive Value and Efficiency (Munther Baara, Director, Clinical Business Systems and Processes, Wyeth Pharmaceuticals)
- From Weeks to Clicks – How Portal Technologies Improve Cycle Times and Increase Efficiencies of Clinical Trials (Greg Cohee, Director, eClinical Services, PHARMICA Consulting)
- Leverage a Portal as an Investigator Relationship Management Tool (Len Rosenberg, Ph.D., RPh, President and CEO, Diasome Pharmaceuticals)
- Apply Governance Standards to Utilize the Investigator Portal as a Gateway to the Enterprise (David M. Rose, M.D., MPH, Research Scientist, Office of Research and Development, Department of Veterans Affairs)
Sponsors and Exhibitors include: ePharma Solutions, Pharmica Consulting, TCN e-Systems, innovocommerce, INTRALINKS, FireCrest Clinical, NextDocs, Compass IRB and Blue Sky Broadcast.
For more information on this event, please visit http://www.cbinet.com/Portals or call 800-817-8601. If you would like to apply for a press pass, please contact Lauren Donoghue at Email or 339-298-2262.
About CBI:
A subsidiary of Advanstar Communications, CBI Research, Inc. offers Pharmaceutical and Healthcare conferences that serve senior executives and government officials by providing a unique platform for highly focused content and ideal networking opportunities with senior policy- and decision-makers. CBI events provide you with concrete, real-life examples that you can begin to apply at your organization immediately for significant impact on costs and revenue. For more information, please visit http://www.cbinet.com.
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