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Gaylord Palms Resort & Convention Center

Mar 21, 2016 1:00 PM - Mar 23, 2016 4:30 PM

6000 West Osceola Parkway, Kissimmee, FL 34746

Medical Affairs and Scientific Communications 2016 Annual Forum

Cross-functional forum spotlights topics related to medical communication, medical science liaison, medical call center, and medical writing professionals.

Back to Agenda

Core Curriculum Session 1 - Part 1: An Introduction to the US Regulatory Environment and Medical Communications Practices

Session Chair(s)

Kristin Fox Goettner, PharmD

Senior Director, Medical Information and Knowledge Integration

Janssen Scientific Affairs, LLC, United States

This presentation will describe how the US regulatory environment impacts medical communications within the pharmaceutical industry. An introduction to key concepts in medical communications practice based on FDA statutes, regulations, policies, and guidance will be provided. In addition, useful regulatory resources that are accessible in the public domain will be shared.