Fundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines, Second Edition serves as an introduction to the international regulatory arena in which biologicals are developed, offering an overview of processes and insights into the scientific concepts underpinning global regulations. This edition provides in-depth coverage of Quality by Design, Combination Products, Risk Management Plans, REMS, and switching from reliance on in vivo to in vitro analytical methods. It reflects new developments and processes accelerated by the COVID-19 vaccine experience, including emergency use authorizations and conditional marking authorizations. New pedagogic elements and case studies have been added to improve learning outcomes. This book provides multiple levels of readership, with guidance on basic concepts, a detailed look at regulatory challenges, and practical insights into how regulators consider regulatory science and regulatory process issues across various regions, with an emphasis on the European Medicines Agency and the U.S. Food and Drug Administration.

• Features new chapters on Advanced Therapy Medicinal Products (including cell and gene therapies), Combination Products, and Pharmacovigilance
• Presents new and updated case studies, including lessons learned from the development of COVID Vaccines
• Provides more in-depth coverage on Quality by Design, and Pharmacovigilance
• Focuses on the principles in regulating Biosimilars, In Vitro Diagnostics, Advanced Therapy Medicinal Products, and Combination Products
• Covers general biologicals' development, authorization, regulatory processes, and scientific principles for CMC, preclinical, and clinical development