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A Comparison of Study Startup Regulations and Timelines in Several Major Emerging Markets and the Decision Process for Selection
Program Code:
337
Date:
Wednesday, June 26, 2013
Time:
10:15 AM to 11:45 AM
EST
CHAIR
:
David Passov,
MBA (SCHNON), Senior Vice President, Eastern Europe,
ClinStar, A PRA Company, United States
Mr. Passov is Sr. VP, Eastern Europe for ClinStar, A PRA Company, and until the recent acquisition by PRA, held the position of President & CEO. He has 17 yrs experience in contract research. He completed a basic science research tenure, received medical training & earned an MBA from Northeastern.
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SPEAKER
(S):
Ori Ben-Yehuda, MD,FACC (SPKSUP), Professor of Clinical Medicine; Director, Coronary Care Unit, University of California, San Diego, United States
Robert A. Baughman,
PharmD,PhD (SPKNON), Senior Vice President, Clinical Sciences,
MannKind Corporation, United States
Dr. Baughman's responsibilities include the design and conduct of clinical trials evaluating investigational drug products. These trials were conducted at clinical sites throughout Europe, Eastern Europe, Latin America and North America.
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Nancy Widener,
MS (SPKNON), Executive Director, Clinical Science and Operations,
Bristol-Myers Squibb Company, United States
Nancy is currently Executive Director Clinical Science and Operations at Bristol Myers Squibb. In this role she is responsible for all aspects of clinical operations, including outsourcing for all early phase assets.
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Description
The panel will explore conventional definitions of emerging markets; critique advantages and challenges of conducting trials in these markets; and examine study startup regulations/timelines and the decision-making process for entering these markets.