FDA and USDA Regulatory Essentials for Pharmaceutical Importers

Thursday 19th March, 12:00 EDT

Importers of pharmaceutical products face strict import requirements not only from CBP, but also from FDA and USDA/APHIS. In addition, FDA only has limited pathways for importing approved drugs and drugs for investigational use. This webinar will lay out these agencies regulatory framework for pharmaceuticals, describe their import requirements, and provide participants with practical knowledge for ensuring imports have the right data and documentation to facilitate smooth clearance without delays.

Elizabeth Lomax has over twenty five years of experience in the trade compliance field. She is the founder and president of Lomax Associates, Inc., a boutique trade consulting practice focusing on the pharmaceutical and biotech industries. Elizabeth's other experience includes the position of Head of Global Trade Compliance for Novartis Pharma AG in Basel, Switzerland. Prior to the global role, Elizabeth was responsible for trade compliance for Novartis' U.S. pharmaceuticals business located in New Jersey. Elizabeth also worked in the customs and trade compliance group at Ernst & Young in New York and in the international trade practice of the law firm of Katten Muchin Zavis in Chicago. She began her career in trade in international purchasing at the V. Mueller division of Baxter Healthcare in Chicago.

Elizabeth is a licensed customs broker and holds a Certificate of Purchasing and Inventory Management (CPIM) from APICS. She holds a B.A. in International Studies and German from Miami University in Oxford, Ohio and an MBA in Finance from Indiana University in Bloomington, Indiana.