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Sheraton Silver Spring

Oct 10, 2018 1:30 PM - Oct 10, 2018 5:00 PM

8777 Georgia Ave, Silver Spring, MD 20910

Short Course: How the MDR will Affect Combination Products

Instructors

Colleen  Heisey

Colleen Heisey

Partner, Jones Day, United States

Colleen Heisey is a Partner at Jones Day in Washington, DC, where her practice focuses on food and drug law, particularly regulatory and compliance counseling on pre- and post-marketing obligations applicable to product manufacturers. She is a problem-solver for the pharmaceutical and medical devices industries, putting her 15+ years of products-oriented regulatory and legal experience to use in developing practical, business-oriented solutions within the permissible regulatory framework. She’s a go-to attorney for clients dealing with post-marketing obligations, from addressing advertising and promotional issues to managing FDA inquiries, inspections, 483s, enforcement matters, and recall situations.

Ian  Pearson

Ian Pearson

Associate, Jones Day, United States

Ian Pearson focuses on FDA regulatory matters, with an emphasis on medical devices, combination products, and the evolving digital health sector. Before joining Jones Day, Ian served for more than seven years in the U.S. Food and Drug Administration's Office of Chief Counsel. During that time he was responsible for providing FDA with legal advice on a wide range of regulatory matters across multiple sectors, and was a member of the device counseling, combination products, and information disclosure teams. In recent years, Ian was an FDA lead in the area of digital health and worked on numerous issues pertaining to mobile medical applications, health information technology, clinical decision support software, and genetic testing.

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