Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines, Second Edition serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. In this new edition the book provides additional coverage of Quality by Design, Combination Products, Target Product Profiles, Quality Target Product Profiles, RiskMAPs, Additional pre-IND assignment, Switching from reliance on in vivo to in vitro analytical methods. It also reflects the new developments and processes accelerated by the COVID-19 vaccine experience. New pedagogic elements and case studies have been added to improve learning outcomes for students. This book provides multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. Graduate students will benefit from the new pedagogic features. Regulatory professionals will have in Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines a complete guide to navigate through the approval process.

• Presents new case studies, including development of COVID Vaccines
• Discusses Biosimilars, In Vitro Diagnostics, Medical Devices, and Combination Products
• Covers general regulatory processes as well as CMC, preclinical and clinical development