Regulatory Affairs: Part I: The IND Phase and Part II: The NDA Phase

9 - 12 January 2011, Irvine, United States

Introduction

Learn how to apply regulatory concepts to ensure compliant IND submissions to the FDA. Gain insight into the regulatory background of the NDA, preparing an NDA, and postapproval activities. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics