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Bethesda North Marriott Hotel and Conference Center

2017年10月24日 (火) 午後 1:00 - 2017年10月24日 (火) 午後 4:30

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Course: Combination Product Advanced Case Studies

Instructors

Nancy  Stade, JD

Nancy Stade, JD

Partner, Sidley Austin LLP, United States

Nancy Stade is a partner in the Food, Drug, and Medical Device regulatory practice of Sidley Austin, LLP, where her practice focuses on counseling medical device companies, manufacturers of combination products, life sciences companies, and makers of consumer products used in health and fitness. Nancy previously held a variety of senior positions at the FDA, including Deputy Director for Policy of the Center for Devices and Radiological Health, where she led the development and implementation of FDA’s device regulatory policy.

Rachel  Turow, JD, MPH

Rachel Turow, JD, MPH

Managing Counsel, FDA Regulatory, Walmart, Inc., United States

Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination products and digital health projects. Rachel also serves as head of regulatory policy for the U.S. Previously, Rachel was Director, Regulatory Policy, at Novo Nordisk Inc. Prior to joining Novo Nordisk, Rachel spent five years at FDA. She was a Regulatory Counsel in CDER’s Office of Regulatory Policy and she served as Special Assistant to Jeff Shuren, Director of CDRH. Rachel holds a JD and MPH from the University of Michigan and a BA in Biology from

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