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Wednesday, June 21 • 2:00pm - 3:15pm
#339: Off-Label Communications to Health Care Providers and Consumers

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-517-L04-P; CME 1.25; IACET 1.25; RN 1.25

Preparing for new FDA policies on off-label communication to health care providers and consumers in light of FDA, court, and other developments.

Learning Objectives

Discuss the newest developments at FDA and industry recommendations for changes in FDA off-label policies.

Chair

John Kamp

Speaker

Scientific Exchange in the Digital Age
Todd M. Hobbs, DrMed

Panelist
Kellie B. Combs, JD

Beyond the Product Label
James M. Spears, JD



Moderators
avatar for John Kamp

John Kamp

Executive Director, Coalition For Healthcare Communication
Dr. John F. Kamp is Executive Director of the Coalition for Healthcare Communication, a medical marketing trade association with offices in New York City and Washington, DC. He is also Consulting Counsel with the law firm Wiley Rein LLP, and is a widely respected advocate for Fir... Read More →

Speakers
avatar for Kellie Combs

Kellie Combs

Partner, Ropes & Gray LLP
Kellie Combs is a Partner in the Washington, DC office of Ropes and Gray, where she advises pharmaceutical, biotech, and medical device companies on a range of FDA regulatory issues, including promotional compliance, lifecycle management, and regulation of clinical research. She... Read More →
avatar for Todd Hobbs

Todd Hobbs

Vice President, Chief Medial Officer, Novo Nordisk A/S
Todd Hobbs, MD, is vice president and chief medical officer for Novo Nordisk in North America, where he leads the organization’s focus on the implications of diabetes for the patient, healthcare system and healthcare professionals. Dr. Hobbs provides overall medical guidance to... Read More →
avatar for John Kamp

John Kamp

Executive Director, Coalition For Healthcare Communication
Dr. John F. Kamp is Executive Director of the Coalition for Healthcare Communication, a medical marketing trade association with offices in New York City and Washington, DC. He is also Consulting Counsel with the law firm Wiley Rein LLP, and is a widely respected advocate for Fir... Read More →
avatar for James Spears

James Spears

Consultant
James M. (Mit) Spears is a Washington DC-based lawyer specializing in biopharmaceutical regulation, competition and communications. A former Executive Vice President and General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA) with over 35 years of expe... Read More →


Wednesday June 21, 2017 2:00pm - 3:15pm
N229 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616