Biotech China 2014
MAGI’s 2008 Clinical Trial Agreements, Budgets & Regulatory Conference – EAST
Hyatt Regency – Crystal City
2799 Jefferson Davis Highway
Arlington, VA

Schedule of Presentations:

Sunday, May 18, 2008
12:00:00 Early Registration
13:00:00 Concurrent Workshops - Choose One
17:00:00 Early Registration
19:00:00 Informal Get-Together in the hotel Lobbibar (no-host)
Monday, May 19, 2008
07:30:00 Registration, Networking & Light Breakfast
08:30:00 Chairman’s Opening Remarks Norman M. Goldfarb
09:00:00 FDA Amendments Act of 2007 Gregory M. Torre
10:00:00 Networking Break
10:30:00 Track B: Budgets Budget Development & Negotiation from A to Z Terence L. Webb, John F. Covin
10:30:00 Concurrent Tracks Begin - Choose from A-D
10:30:00 Track D: Regulatory Site Initiation for Sponsors Julia B. Isbell
10:30:00 Track C: Special Topics Clinical Trial Registries David Heck
10:30:00 Track A: Contracts Managing Risk: Indemnification, Subject Injury & Insurance Lori Spencer, Barbara Longmire, Jeffrey Klein
11:00:00 Track C: Special Topics Clinical Trial Agreements in the United Kingdom Harriet Wibberley
11:00:00 Track D: Regulatory Study Initiation for Sites Suzanne Coleman
12:00:00 Lunch with Speakers
13:15:00 Track A: Contracts Publication & Intellectual Property Rights: Finding the Common Ground LaDale George, Orman Simpson, Stacie S. Switzer
13:15:00 Track D: Regulatory Working with IRBs Sheila B. Noone, Matt Baker
13:15:00 Track B: Budgets The Sponsor’s Role in Medicare Reimbursement for Device Trials Linda Johnson
13:15:00 Track C: Special Topics Profitable Clinical Research for Physician Offices & Clinics Dave Jones, William B. Smith
13:45:00 Track B: Budgets Phase IV Study Budgets Gina Morton
14:15:00 Track B: Budgets Making, Tracking & Collecting Payments Geoffrey Schick
14:45:00 Networking Break
15:15:00 Track C: Special Topics The Three Rs: Reading, ’Riting & ’Rithmeticing Clinical Trial Agreements & Budgets Terry Stubbs, Sylvia Lewis
15:15:00 Track B: Budgets Inside the OIG’s Toolbox David Vulcano
15:15:00 Track D: Regulatory Adverse Events & Deviations
15:15:00 Track A: Contracts Negotiating Clinical Trial Agreements outside the U.S. John W. Herrmann
16:00:00 Track A: Contracts Don’t Forget the Other Contract Terms C. Elizabeth O'Keeffe, Jane A. Wilcox
16:00:00 Track B: Budgets Medicare Reimbursement for Clinical Trials Douglass Reichgott, Barbara Veath
16:00:00 Track D: Regulatory Informed Consent Caroline Rogers, Quincy J. Byrdsong
17:00:00 Track A: Contracts Clinical Trial Agreements in Canada John Akitt, Karen Arts
17:00:00 Track B: Budgets Billing Compliance in Practice Debbie McAllister, Patricia Bass
17:00:00 Track C: Special Topics Hospital/CRO Collaborative Partnerships Thomas F. Pianta, Adam R. Chasse
17:00:00 Track D: Regulatory From CRF to Database Pati Stone
17:45:00 Networking Reception
Tuesday, May 20, 2008
07:30:00 Registration, Networking & Light Breakfast
08:15:00 Chairman's Remarks
08:30:00 Face-Off: Subject Injury Mock Trial Wayne Bond
09:30:00 Negotiation Magic: Skills & Techniques Barry Sagotsky
10:15:00 Networking Break
10:45:00 Track A: Contracts Sensible Payment Terms John Akitt, Leann Frankel
10:45:00 Track D: Regulatory Delegation of Authority at Research Sites Belinda Vandersluis
10:45:00 Concurrent Tracks Begin - Choose from A-D
10:45:00 Track B: Budgets Pricing Patterns & Trends Ying Jiang
10:45:00 Track C: Special Topics When Clinical Research Meets Tech Transfer Mark G. Bloom
11:15:00 Track B: Budgets Investigator-Initiated Trial Budgets Jen Runne
11:15:00 Track D: Regulatory FDA Inspections of Research Sites Cheryl Dubenezic
11:15:00 Track C: Special Topics Outsourcing Contract & Budget Negotiation to CROs Sharon Gordon, Bill Hansen
11:45:00 Track A: Contracts Clinical Trial Agreements for Investigator-Initiated Trials Frederick M Frankhauser
11:45:00 Track B: Budgets NIH Grants & Proposals Matthew Staman, Rebbecca A. Moen
12:15:00 Track C: Special Topics Identifying Problem Investigators
12:15:00 Track A: Contracts Clinical Trial CRADAs with the Department of Veterans Affairs Jeffrey Moore, Amy Centanni
12:15:00 Track D: Regulatory Regulatory Challenges in International Subject Recruitment Diana L. Anderson
13:00:00 Lunch: Birds of a Feather
13:45:00 OPTIONAL: Clinical Research Contract Professional (CRCP) Certification Exam
14:15:00 Track D: Regulatory Conflicts of Interest Priya Sankar
14:15:00 Track B: Budgets Budgeting for International Trials Lori Shields
14:15:00 Track A: Contracts Other Intellectual Property Agreements Alan Jakimo
14:15:00 Track C: Special Topics Understanding Your Insurance Policy Lyn Rossano
14:45:00 Track D: Regulatory Investigator-Initiated Trials Harvey M. Arbit
14:45:00 Track B: Budgets Managing Currency Risks in International Trials
15:00:00 Track C: Special Topics Multimedia Informed Consent Susan Brink
15:45:00 Networking Break
16:15:00 Stump the Experts
17:00:00 Chairman's Closing Remarks
Wednesday, May 21, 2008
07:15:00 Registration, Networking & Light Breakfast
08:00:00 Concurrent Workshops - Choose One
08:00:00 Workshop D: Practical Negotiation Barry Sagotsky
08:00:00 Workshop E: Clinical Research Law & Litigation Wayne Bond, Fred Rom
08:00:00 Workshop C: Budget Development & Negotiation for Large Investigative Sites Geoffrey Schick
08:00:00 Workshop B: The Big Four Terms: Indemnification, Subject Injury, Intellectual Property, and Publication Right Penny Smith, Suzanne Page, Julia Jackson
08:00:00 Workshop A: Dissecting a Clinical Trial Agreement J. Andrew Lemons, Anne Prather, Mark E. Boulding
12:00:00 Networking Lunch
13:30:00 OPTIONAL: Clinical Research Contract Professional (CRCP) Certification Exam
14:45:00 Conference Concludes
4th Annual Pharma R&D Asia Congress
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