Therapeutic Product Development: A Regulatory Overview

Catalog description

Examines every step of the biotherapeutic development and regulation process within the U.S. FDA's Center for Biologic Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). Enrolled students receive didactic instruction from product formulation, product development, and preclinical testing perspectives through postmarketing adverse experience reporting. Offers students an opportunity to study FDA standards for nonclinical testing-quality assurance issues and good laboratory practice, investigational new drug (IND) applications, therapeutic market applications and review processes designed to speed therapeutic product review, as well as current good manufacturing practice and operations management regulations.