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US Regulatory and Compliance Considerations

Increase your understanding of regulations and guidance around the dissemination of information about drug products in the US.

Authors

Ellen  Whipple, PharmD

Ellen Whipple, PharmD

Owner/Principal Writer, EW Associates, LLC, United States

Ellen is the co-owner of Scientific Content Solutions, LLC and the sole proprietor of EW Associates, LLC. She was previously a director of medical communications with an agency. Ellen has experience with medical information-related documents (e.g., standard letters, FAQs, dossiers, escalated inquiries), continuing education articles, primary author publications, promotional review, payer materials, and advisory board meeting reports. As a member of AMCP Format Executive Committee, Ellen contributed to AMCP Format 4.1. She serves as a Clinical Assistant Professor at the University of Georgia College of Pharmacy. Since 2000, Ellen has been a Medical Advisor for the MS Foundation.

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