11th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials
Affinia Manhattan Hotel
371 7th Avenue
New York, NY

Schedule of Presentations:

Tuesday, February 24, 2009
07:30:00 Registration and Breakfast
08:45:00 Co-Chairs’ Opening Remarks Charlene A. Gallagher, Aaron Rodriguez
09:00:00 external Government Investigations and Enforcement Priorities of Clinical Practices Michael J Sullivan, Karena Cooper, John S. Darden, James Czaban
10:15:00 Morning Coffee Break
13:15:00 priorities of a New Administration: Responding to Changes in Scrutiny, Enforcement Budgets and Legislative Initiatives
14:35:00 Afternoon Coffee Break
14:40:00 Minimizing Conflicts of Interest When Administering a Clinical Trial Robert B. Nicholas, Elizabeth V Jobes
15:30:00 Identifying and Overcoming Challenges in Negotiations Between the Sponsor and the CRO BRADLEY MERRILL THOMPSON, David Vulcano
16:45:00 Instituting Policies to Expedite Medicare Approval for Clinical Trial Costs and Expenses Molly G Huggins, Douglass Reichgott
17:15:00 Conference Adjourns
Wednesday, February 25, 2009
07:30:00 Registration and Breakfast
08:45:00 Co-Chairs’ Opening Remarks
09:00:00 Preventing Charges of Off-Label Promotion When Disseminating Clinical Trial Materials Charlene A. Gallagher, Alan G Minsk, Lori G Cohen
10:15:00 Morning Coffee Break
10:25:00 Avoiding Clinical Trial Delays While Developing Successful Partnerships with an IRB Cynthia M Gates, Michael J. Meehan
12:00:00 New Presentation
12:00:00 New Presentation
12:00:00 Networking Luncheon for Speakers and Delegates
13:15:00 Avoiding FDA Review through Compliant Adverse Event Reporting Jayne Bultena
13:50:00 Protecting, Monitoring and Maximizing Data: IP Rights, Publication and Confidentiality Joan S Antokl
14:00:00 Registration
14:25:00 Conference Concludes
14:30:00 Workshop B: International Clinical Trials Boot Camp: The A to Z guide of essentials you need to know before going overseas Dorota Poklonska, Elizabeth M Zechenter, Penny Smith
17:30:00 Conference Adjourns for the Day
Thursday, February 26, 2009
08:00:00 Registration and Continental Breakfast
08:30:00 Co-Chairs’ Opening Remarks
08:45:00 Roadmap to Emerging Regions: Navigating the Regulatory and Legal Frameworks of Central & Eastern Europe, Latin America, Africa, India, and the Middle East Shannon Shanahan, Cristiana Spontoni, Domingo Rodriguez
10:15:00 Morning Refreshment Break
10:25:00 Ensuring Compliance with FDA Requirements When Conducting Global Trials Daniel A Kracov
11:15:00 GCP Challenges in Emerging Regions: Ensuring Ethical Integrity David Forster, Jose Luis Viramontes, Maureen Bennett
12:40:00 Networking Luncheon for Speakers and Delegates
13:55:00 Negotiating Key Contract Terms: Essential Provisions to Minimize Risk & Maximize Profitability Michael G Eckstein
15:00:00 Afternoon Refreshment Break
15:10:00 Complying With the FCPA & Overcoming Practical Constraints with Foreign Partners John F Kuckelman, Karl H Buch
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