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Washington Marriott Wardman Park

18 feb 2015 8:00 a.m. - 19 feb 2015 5:00 p.m.

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

Marketing Pharmaceuticals 2015: Drug/Device Marketing in an Evolving Environment

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Session 3: Scientific Exhange

Session Chair(s)

Mark Gaydos

Mark Gaydos

Head of Labeling and Advertising & Promotion, Global Regulatory Science

Moderna, United States

Scientific exchange is a broadly defined concept that continues to be hotly debated and widely interpreted within the pharmaceutical industry. In recent years, activity in this area has intensified with important court decisions and increased pressure on FDA to clarify its position on the scope of activities and communications that fall within the scope of scientific exchange. Our session will examine these recent developments, including the evolving legal and regulatory landscape, as well a medical perspective given the key role this function has traditionally played in this area.

Speaker(s)

Mark Gaydos

Scientific Exchange: A Regulatory Overview

Mark Gaydos

Moderna, United States

Head of Labeling and Advertising & Promotion, Global Regulatory Science

Torrey Cope, JD

Changing Regulatory & Legal Landscape: What Does it Mean for Scientific Exchange?

Torrey Cope, JD

Sidley Austin LLP, United States

Partner

Lisa C. Dykstra

DOJ’s Stance on Scientific Exchange

Lisa C. Dykstra

Morgan Lewis, United States

Partner

Ira B Steinberg

Medical Affairs: The Science Behind Scientific Exchange

Ira B Steinberg

Boston Biomedical Pharma, Inc., United States

Vice President, Medical Affairs

Panel Discussion

Panel Discussion

All Session Speakers, United States

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