Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Understanding enhanced regulatory science and strategy and translating new discoveries into real-world products can make an enormous difference for individual and population health. However, doing so is fraught with challenges requiring coordinated work across disciplines, sectors and, increasingly, across nations. The new edition of Global Pharmaceutical and Biologics Regulatory Strategy outlines a systematic approach, spanning everything from the earliest stages of research and development to postmarketing, taking into account the challenges and realities of a global strategy to meet the requirements of multiple regulatory systems. Updated by a group of distinguished regulatory experts, this second edition provides the essential elements of an integrated regulatory approach, including the ABCs of regulatory strategy and the whys and wherefores of interacting with regulators. Other chapters cover more technical aspects of the product lifecycle and regulatory oversight, such as preclinical and clinical development, expedited pathways, orphan designation, pediatric products, and product formulation, manufacturing and control.