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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
Duke University School of Medicine, United States
Instructor, Medicine
注册方法
Registration override should work.