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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

A Comparison of Study Startup Regulations and Timelines in Several Major Emerging Markets and the Decision Process for Selection

Session Chair(s)

David  Passov, MBA

David Passov, MBA

SVP, Strategic Advisory Partner

PRA Health Sciences, United Kingdom

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.

Learning Objective : Describe what defines an emerging market; Discuss the advantages and challenges of conducting clinical trials in emerging markets; Explain how several major markets compare in study startup regulations, timelines, and the decision process for country selection.

Speaker(s)

Ori  Ben-Yehuda, MD, FACC

Panelist

Ori Ben-Yehuda, MD, FACC

Cardiovascular Research Foundation, United States

Executive Director, Clinical Trials Center

Robert A. Baughman, PharmD, PhD

Panelist

Robert A. Baughman, PharmD, PhD

MannKind Corporation, United States

Senior Vice President, Clinical Sciences

Nancy  Widener, MS

Panelist

Nancy Widener, MS

Bristol-Myers Squibb Company, United States

Executive Director, Clinical Science and Operations

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