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Renaissance Washington DC Dupont Circle Hotel

Oct 24, 2016 1:30 PM - Oct 24, 2016 5:00 PM

Formerly Renaissance M Street Hotel, 1143 New Hampshire Avenue, NW, , Washington, DC 20037 , USA

Course: Digital Health Technologies for Combination Products and Beyond: Development and Regulation

Instructors

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

Wade  Ackerman, JD

Wade Ackerman, JD

Partner, Covington & Burling LLP, United States

Wade Ackerman is a partner in Covington’s Food, Drug, and Device practice. Until June 2016, Mr. Ackerman served as Senior FDA Counsel to the U.S. Senate Health Education, Labor & Pensions Committee where he was involved in legislative initiatives, oversight hearings, and other Senate activities concerning the FDA and the Federal Food, Drug, and Cosmetic Act. He worked with the FDA and other stakeholders as Congress examined legislative reforms in key areas, including drug and device innovation, diagnostics, health software, and combination products. Through private practice and roles at the FDA and on the Hill, Mr. Ackerman developed a unique insight into the legal and regulatory issues surrounding the marketing of FDA-regulated products.

Christina  Kuhn, JD

Christina Kuhn, JD

Partner, Covington & Burling LLP, United States

Christina Kuhn is a senior associate in Covington’s Washington, DC office, where she advises clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, but also includes advising on pharmaceuticals and biotechnical products. She regularly works clients across the spectrum of medical devices technologies, including eHealth products, diagnostics, and combination products. She counsels companies on clinical development and premarket regulatory strategies as well as on postmarket compliance requirements and responses to enforcement actions. She is also a regular contributor to Covington’s InsideMedicalDevices blog.

Pat  Baird, MBA, MSc

Pat Baird, MBA, MSc

Global Head of Software Standards, Philips, United States

Pat Baird recently joined Philips as the Head of Global Software Standards, responsible for actively participating in the development of software standards and translating those standards into usable business processes. Previously he was Director of Risk Management at Baxter Healthcare. Drawing on 20 years’ experience in product development, he has published and presented over 50 papers on topics such as software development, change management, stakeholder management, and risk management. In addition to an MBA, he has a Masters in Healthcare Quality and Patient Safety from Northwestern University.

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