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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 7A: Substantial Evidence and Beyond

Session Chair(s)

Kristina Vlaovic, MPH

Kristina Vlaovic, MPH

Vice President, Regulatory, Safety and Pharmacovigilance

HALOZYME Inc., United States

Substantial Evidence is the cornerstone of regulatory principles, however on a daily basis regulatory professionals are challenged to consider how to utilize other sources of data in a truthful and non-misleading manner. This interactive session will give the participants an opportunity to work through interesting case studies and discuss openly with their peers best practices and considerations for developing compliant materials.

Speaker(s)

Sue E. Duvall, MBA, MPA, RN

Speaker

Sue E. Duvall, MBA, MPA, RN

GoProMo LLC, United States

Leah Palmer, PHARMD

Speaker

Leah Palmer, PHARMD

United States

Consultant, Regulatory Promotion

Lynette Hopkinson

Speaker

Lynette Hopkinson

Vertex Pharmaceuticals Incorporated, United States

Vice President, Commercial Regulatory Affairs, Global Regulatory Affairs

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