Description
This second edition of Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines 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 more in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans and REMS, and switching from reliance on in vivo to in vitro analytical methods. This new edition also reflects the 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 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 with emphasis on the European Medicines Agency and the U.S. Food and Drug Administration. 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.• 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• More in-depth coverage on Quality by Design, Quality Target Product Profiles, and Pharmacovigilance• Chapters focusing on the principles in regulating Biosimilars, In Vitro Diagnostics, Advanced Therapy Medicinal Products, and Combination Products• Covers general biologicals development and authorization regulatory processes as well as scientific principles for CMC, preclinical and clinical development• Also covers ethical considerations for use of laboratory animals and human subjects protections, as well as genetically modified organisms used in or as medicines
Table of Contents
About the authorsForewordPrefaceHow to obtain documents from ICH and USSECTION I: Regulatory process1 Introduction to the regulatory process for biologicals and to international regulatory convergence2 Discovery and development3 Communications and formal meetings with regulators4 Clinical trial authorization and investigational new drug applications5 Marketing authorization6 Alternative regulatory pathways and special programs7 Variations or changes to an approved application8 Good "X" Practices9 Audits and regulatory compliance inspectionsWritten assignments exerciseAssignment Scenarios SECTION II: Regulatory science10 Preclinical safety and toxicology11 Preclinical pharmacology, proof‑of‑principle12 Institutional biosafety committees and regulation of genetically modified organisms13 Risk assessments14 Quality by design and product design, construction, development, manufacture, and process validation15 Lot release, analytics, and analytical validation16 Regulatory aspects of clinical trials17 Pharmacovigilance, safety reporting, and risk minimization18 Clinical trial ethics, human subjects protections, and the informed consent process19 Independent ethics committees and institutional review boards SECTION III: Specific product types20 Biosimilars21 Cell and gene therapies22 In vitro diagnostics and biotech medical devices23 Combination productsGlossaryIndex
