SPONSORS:
McCarter & English, LLP Maximizing the Outcome of Your Clinical Trials
Jeffrey A. Baumel
[email protected] Thursday, February 9, 2006
8:00 a.m. 1:30 p.m.
Québec Government House Newark Club
Laurent Waessa One Newark Center
[email protected] 22nd Floor
Newark, NJ, 07102
Commerce Insurance Services Directions
Michael D. Smith, Jr.
Michael.smith.jr@yesinsurecom Please join us for a morning of discussion and networking designed to bring together
biotechnology and pharmaceutical executives from New Jersey, New York and the
Philadelphia area, and leading Contract Research Organizations CROs from Québec.
Breakfast, beverages and luncheon will be served.
The event will be a unique opportunity to learn how to maximize the outcome of your
clinical trials in a wide variety of therapeutic areas, including oncology, cardiology,
endocrinology, and CNS. A panel of recognized experts will address the regulatory, legal
and other considerations when setting up and running successful clinical trials.
Executives from Pfizer and Duravest, Inc. will share their experience on running clinical
trials in Québec.
Six leading CROs will present their clinical trial expertise and introduce Québec as a cost
competitive and attractive location in which to conduct clinical trials. This is an exclusive
invitationonly event for biotechnology and pharmaceutical companies in late stage
clinical trials or in early stage with great promise for successful commercial
development.
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AGENDA
8:00 8:30 a.m. : Registration/Breakfast/Opening Remarks and Welcome Message
8:30 10:30 a.m. : Panel on Regulatory, Legal and Other Considerations in Outsourcing
Clinical Trials in Canada/Québec and the U.S.
Regulatory environment
Sylvie Ducharme, Director of Operations and Business Development, SPharm Inc.,
Val d’Or, Canada
Managing the Risks of Doing Clinical Trials
Michael D. Smith, Jr., Assistant Vice President, Commerce Insurance Services, Life
Science Division, Randolph, New Jersey
The Role of Clinical Trials in Product Liability Litigation: You're More Involved
Than You Think
John Brenner, Attorney from the Biotechnology Practice of McCarter & English, LLP,
Newark, New Jersey
Legal Considerations for Clinical Trials in Quebec, Canada
Karima Kanani and André Dugas, Miller Thomson LLP
Pfizer’s experience in Running Clinical Trials in Québec
Dr. Christian Marsolais, Director, Scientific Affairs, Pfizer Canada Inc., Medical Division,
Kirkland, Canada
10:30 10:45 a.m. : Networking Break
10:45 12:30 p.m. : Setting up and Running Successful Clinical Trials in Québec
Presentations by 5 leading Québec CROs:
Montréal Heart Institute Coordinating Center, Richard Côté, Director Business
Development
Scimega Research Inc., Denise Deakin, Vice President Sales & Marketing
MedQualis, Brigitte Marcheterre and TrialStat!, Khaled El Emam
Integrated Research Inc., Joanne Watson, CEO
CIRION Clinical Trial Services Inc., Peter Colbourne, Director, Business Development
12:30 1:30 p.m. : Buffet Networking Lunch and Keynote Speaker
Dr. Ogan Gurel, CEO of Duravest, Inc., a Chicagobased publicly traded holding company
investing in leading edge medical technology. Its subsidiary, Estracure, Inc. is currently
conducting clinical trials in Québec for its nextgeneration coronary stenting products .
1:30 p.m. : Conclusion and Adjourn
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RSVP OR QUESTIONS
Please send an e mail with your contact information to:
Tangi Holmes
[email protected]
Tel. 973.639.6958
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COMPANY INFORMATION
List of companies
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