Description
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
Table of Contents
SECTION I REGULATORY PROCESS1. Introduction to the Regulatory Process for Biologicals2. International Regulatory Convergence3. Quality by Design (QbD) Approach to Discovery and Development4. Communications and Formal Meetings With Regulators: Focusing on the Process Before Clinical Trial5. Clinical Trial Authorization and investigational New Drug Applications6. Marketing Authorization7. Alternative Regulatory Pathways and Special Programs8. Variations or Changes to an Approved Application9. Good "X" Practices10. Audits and Regulatory Compliance inspectionsSECTION II REGULATORY SCIENCE PART I PRECLINICAL11. Preclinical Safety and Toxicology12. Preclinical Pharmacology , Proof-of-Principle13. Institutional Biosafety Committees and Regulation of Genetically Modified Organisms14. Risk AssessmentsPART II PRODUCT15. Product Construction, Manufacture, and Process Validation16. Analytical Method Development and Validation Leading to Control Strategy and Lot ReleasePART Ill CLINICAL17. Regulatory Aspects of Clinical Trials18. Pharmacovigilance and RiskMAPs19. Clinical Trial Ethics, Human Subjects Protections, and the Informed Consent process20. Independent Ethics Committees and Institutional Review BoardsSECTION Ill PRODUCT-SPECIFIC REGULATORY PROCESSES21. Biosimilars22. In Vitro Diagnostics and Biotech Medical Devices23. Combination Products24. Regulatory Policy and Public Health Policy
