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Grand Hyatt Washington at Washington Center

Feb 19, 2013 1:30 PM - Feb 19, 2013 5:00 PM

1000 H Street, NW, , Washington, DC 20001-4310 , 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.

Paul  Savidge, JD, MBA

Paul Savidge, JD, MBA

Senior Regulatory Counsel, Spark Therapeutics, Inc., United States

Paul Savidge is senior regulatory counsel at Spark Therapeutics, a leading gene therapy company, where he provides counsel on a broad range of issues, including those related to drug development and commercialization. Prior to joining Spark, Paul was senior vice president and deputy general counsel at Bristol-Myers Squibb and led the legal groups assigned to the company’s global commercial and research organizations. Prior to BMS, Paul held positions in the U.S. and European legal departments at Merck. Paul received his JD from Washington & Lee University, an MBA from the Kellogg School of Management at Northwestern University and a BSFS from Georgetown University’s School of Foreign Service.

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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