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Walter E. Washington Convention Center

Jun 14, 2015 2:30 PM - Jun 18, 2015 6:45 PM

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

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Regulation of Combination Products in the 21st Century

Session Chair(s)

Michelle Taylor McMurry-Heath, MD, PhD

President and CEO

BIO, United States

This forum will focus on the regulatory challenges facing combination product development and pending US legislative proposals to address them. Panelists will explore the influence of and impact on global regulatory policy for combination products.

Learning Objective : Describe the current and future environment for regulating combination products in the United States and potential global influence; Discuss the US legislative proposals’ ability to address the challenges of today and the goals of future combination product technologies; Assess the current regulatory risks and future opportunities when determining the value of developing combination products.

Speaker(s)

US Legislative Developments on Combination Products

Wade Ackerman, JD

Covington & Burling LLP, United States

Partner

Taiwan Regulatory Perspective

Li-Ling Liu

TFDA, Taiwan

Director, Division of Medicinal Products

FDA Perspective

Robert M. Califf, MD

FDA, United States

Commissioner

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