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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.