viernes, 29 de septiembre de 2017

FDA Law Blog: FDLI’s Introduction to U.S. Biologics and Biosimilars Law and Regulation

FDA Law Blog: FDLI’s Introduction to U.S. Biologics and Biosimilars Law and Regulation



Posted: 28 Sep 2017 12:23 PM PDT
Hyman, Phelps & McNamara, P.C.’s Mark I. Schwartz will be presenting on the Regulation of Biological Manufacturing at the Food and Drug Law Institute's (“FDLI’s”) Introduction to U.S. Biologics and Biosimilars Law and Regulation course, which is scheduled to take place from October 4-5, 2017 in Washington, DC.  A copy of the conference agenda is available here.

FDLI’s course is designed for new legal and regulatory professionals as well as seasoned professionals new to the topic or wanting a refresher.  The program explores the regulation of biological products, including biotechnology–derived therapeutic proteins, human tissue, gene, and cell products. Attendees will learn about the abbreviated pathway to market for biosimilar biological products and associated intellectual property issues, including exclusivity and biologics patent litigation. Case studies, hypotheticals, and ample time for Q&A are provided.

To learn more and to register for the conference, visit www.fdli.org/programs. Use discount code “save15”  to save 15% off your registration fee.


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