Fundamentals of Biologicals Regulation

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. This book will provide 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 numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals.

• Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond
• Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different
• Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated
• Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products

Graduate students and professors in biotechnology, pharmaceutical science and regulatory science programs, regulatory officials, industry professionals

Section I: Regulatory Process

1. Introduction
2. Discovery and Development of Biologicals
3. International Harmonization
4. Pre-IND Profess, Guidance from Regulators in Advance of a Clinical Trials Application
5. Clinical Trials Approvals and Investigational New Drug Applications
6. Marketing Authorization Processes
7. Special Regulatory Programs
8. Post-Marketing Changes to an Approved Application or Variations
9. Compliance and Inspections
10. Good "X" Practices

Section II: Regulatory Science

11. Preclinical Safety and Toxicology
12. Preclinical Proof-of-Concept and Pharmacology, Animal Use Ethics
13. Genetically Modified Organisms and Institutional Biosafety Committees
14. Risk Assessments
15. Chemistry, Manufacturing, and Controls Information (CMC) and Process Validation
16. Analytics, Analytical Validation, Lot Release, and National Control Laboratories
17. Regulatory Aspects of Clinical Trials
18. Ethics of Clinical Trials and the Informed Consent Process
19. Institutional Review Board Processes (Ethics Committees)
20. Biosimilars
21. In Vitro Diagnostics
22. Regulatory Policy and Public Health Policy