DETAILED AGENDA:
Agenda topics and speaking faculty for the conference are currently being organized. If you are a senior-level executive with expertise in any area of rest-of-world clinical trial partnerships; and would like to be considered as a member of the executive speaking faculty for this event, contact the conference co-chair and program organizer:

Michael G. Eckstein, President, Topaz Clinical at 610-525-3634 or m.eckstein@topazclinical.com

MONDAY, MARCH 23, 2009
7:30 – 8:30	Registration & Networking
8:30 - 8:40	Welcoming Remarks Michael Eckstein, President Topaz Clinical
8:45 – 9:30	"State of the Industry" Keynote Panel Panelists: Professor Johan Karlberg, Director, Clinical Trials Centre The University of Hong Kong Dr. Kathleen Thompson Culkin – Director, Operations and Portfolio Management GlaxoSmithKline (INVITED)
9:35 – 10:20	Key Elements of Effective CTAs and MSAs overseas legally binding documents and contracts payments made for service rendered dispute resolution governing law and venue third parties vendors; managing the "daisy chain" model Panelists: Teresia L. Bost, Corporate Counsel Celgene Corporation
10:20 - 10:50	Refreshments & Networking Break Sponsored By:
10:55 - 11:40	Protecting IP Rights In International Jurisdictions one country vs. multi-country issues the "work for hire" concept creating an effective MSA and CTA for IP protection discoveries working under the protocol vs. indirect serendipity Panelists: Dianne C. Kikta, PhD, MBA, Vice President, Global Clinical Strategic Resourcing WYETH Troy Prince, Associate Thompson Hine LLP
11:45 - 12:25	International Clinical Trial Budgets how to establish negotiations enforcement ROI justification the three legs of the "clinical trial budget stool" Panelists: Ross D. Pettit - Vice President, Clinical Operations ARIAD PHARMACEUTICALS, INC. Holly E. Squires, Senior Vice President TTC, LLC
12:30 – 1:45	NETWORKING LUNCHEON
1:50 – 2:35	Managing the CRO Relationship(s) Over 10, 20 or More Countries the global CRO vs. the local CRO roles and responsibilities accountability, audit and monitoring issues CRO promises: "we can do everything" vs. "here is our specific expertise" Panelists: Frederick L. Naids Ph.D Senior Strategic Sourcing Director Clinical R&D Shire Pharmaceuticals Andrew Fleming Executive Director, Business Development PharmaNET Kathi Durdon, MA, CCRP, Clinical Operations Welch Allyn
2:40 – 3:30	Effective Use of SMO Organizations understanding the SMO concept SMO roles and responsibilities how to evaluate and choose an SMO defining SMO deliverables vs. CRO responsibilities holding SMOs accountable for their contacted sites and resources
3:30 – 4:00	Refreshments & Networking
4:05 – 4:50	Emerging Markets: Special Considerations For International Clinical Trials trends and forecasts disease states and patient flows infrastructure, judicial, political and considerations regulatory and "clinical trial friendliness" profile Panelists: Mohinder Bathala, Ph.D, Senior Director Bioanalysis and Metabolism Daiichi Sankyo Pharma Development Dmitry Shaikin, MD, CEO Outsourcing Clinical Trials (OCT) Dr. Vinod Matto, Director, Cardiovascular and Metabolics Bristol-Myers Squibb (Singapore) Boris N. Reznik, Ph.D, Chairman bioRASI, LLC
4:55 – 5:55	SOLUTIONS PROVIDER "SHOWCASE" Hear from four (4) leading solution providers regarding the unique issues involved in outsourcing clinical trials, manufacturing and other services across international boundaries. VENDOR PRESENTATION: Grants Manager Contracting: Online Methods of Negotiating Grants Presenter: Jessica Dolfi, MS, Client Relations Specialist Medidata Solutions, Inc If your company has a product or service to help US-based sponsors to do business in the Rest-of-World, and would like to gain exposure in front of our senior level executives who are eager to learn more about YOU, please contact: Kellie Swanstrom, VP Business Development, iiBIG 973-571-0867 – kellies@iibig.com
6:00 – 7:30	Evening Networking Reception
TUESDAY, MARCH 24, 2009
8:00 – 8:45	Networking & Registration
8:45 – 9:30	Patient Recruitment: New Languages and Cultures language issues cultural and social attitudes regarding clinical trials governmental standard of care issues local physician-patient paradigm traditions best-of-class retention strategies Panelists: Gail Adinamis, President Clinical Resource Network Liz Moench, President & CEO MediciGlobal (Invited)
9:35 – 10:20	ROW Financial Challenges: Currency Impacts and VAT trial budgets: US$ or local currency duration and frequency of ROW payments VAT rates and assessments pre-launch and post launch efforts the critical issue: in country registration Moderator: Michael G. Eckstein, President Topaz Clinical Panelists: Cory Gutterman, Associate Director Outsourcing Abbott Laboratories Marc Rich, MS, MBA, Vice President, Financial Affairs Maximax, Inc.
10:20 – 10:50	Morning Break & Networking
10:55 – 11:40	Liability and Insurance Issues in ROW Countries global policies vs. required local coverage blanket policies vs. specific trial requirements indemnification and hold harmless clauses adjunct D&O and other non-clinical insurance determination of risk-premium rations Panelists: Catherine Mulligan, Assistant Vice President William Gallagher Associates Teresia L. Bost, Corporate Counsel Celgene Corporation James Bird, Partner Jardine Lloyd Thompson (Invited)
11:45 – 12:30	Translation, Certification and Notarization evaluating the right translation company effective formats and layouts of translated documents the "local language" issue: "Spain" Spanish vs. "Mexican" Spanish certification and notarization: why needed pricing issues Panelists: Dianne C. Kikta, PhD, MBA, Vice President, Global Clinical Strategic Resourcing WYETH
12:30	End of Conference: Thanks for Thinking iiBIG!