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Washington Marriott Wardman Park

Feb 17, 2015 1:30 PM - Feb 17, 2015 5:00 PM

2660 Woodley Road, NW, , Washington, DC 20008 , USA

OPDP/APLB and Compliance 101: A Primer

Speakers

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.

Felecia  Ettenberg, JD

Felecia Ettenberg, JD

Executive Director, Promotion Integrity, Bristol-Myers Squibb, United States

Felecia Ettenberg heads up BMS' promotion regulatory group known as Promotion Integrity which has responsibility for all US marketed products. She is an attorney and has been with BMS since 2001 in various roles of increasing responsibility including BMS' litigation group and legal commercial/regulatory group. Prior to joining BMS, Felecia worked at private law firms working on product liability litigation representing various pharmaceutical companies. Felecia received a BA, magna cum laude, from Cornell University and a JD from Boston University.

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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