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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

Of Counsel, FDA Regulatory , Skadden, United States

A former regulatory counsel at FDA, Ms. Turow also served as in-house counsel at multinational developers and sellers of highly regulated products. Her experience spans cosmetics, dietary supplements, food, over-the-counter and prescription drugs, medical devices and combination and digital health products. Prior to joining Skadden, Ms. Turow oversaw regulatory strategy and compliance in various in-house counsel roles, including at major pharmaceutical manufacturers. Most recently, she led the regulatory legal team at one of the world’s largest retailers. She directed a team of lawyers focused on a variety of regulatory issues related to consumer products, reduced legal risks across diverse product categories, developed policies and p

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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