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Bethesda North Marriott Hotel and Conference Center

Mar 02, 2016 1:30 PM - Mar 02, 2016 5:00 PM

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

Tutorial: OPDP/APLB 101: A Primer Based on Today’s Changing Environment

Instructors

Lucy  Rose, MBA

Lucy Rose, MBA

President, Lucy Rose and Associates, United States

Lucy graduated as a physician assistant, earned an MBA, and worked for seven years in sales and sales training with Bristol-Myers Squibb prior to serving as the Director of the Division of Drug Marketing, Advertising, and Communications and the Office of Training and Communications at FDA. For the last 18 years she has consulted with numerous pharmaceutical companies on promotional regulations/strategy, drug development and regulatory strategy, health policy, and has enjoyed training many professionals on advertising/promotional regulations.

Michele  Sharp, PharmD

Michele Sharp, PharmD

Senior Director, Global Regulatory Affairs, Eli Lilly and Company, United States

Michele Sharp joined Lilly in 1995 where her career has included assignments in Medical and Regulatory Affairs. Her experience in Regulatory includes labeling development, working with a product team and the FDA to obtain regulatory approvals, and for the last 13 years leading a team who advise the US business on advertising and promotion for marketed products.

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