Full 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.
Contents
SECTION I REGULATORY PROCESS
1. Introduction to the Regulatory Process for Biologicals
2. International Regulatory Convergence
3. Quality by Design (QbD) Approach to Discovery and Development
4. Communications and Formal Meetings With Regulators: Focusing on the Process Before Clinical Trial
5. Clinical Trial Authorization and investigational New Drug Applications
6. Marketing Authorization
7. Alternative Regulatory Pathways and Special Programs
8. Variations or Changes to an Approved Application
9. Good "X" Practices
10. Audits and Regulatory Compliance inspections
SECTION II REGULATORY SCIENCE
PART I PRECLINICAL
11. Preclinical Safety and Toxicology
12. Preclinical Pharmacology , Proof-of-Principle
13. Institutional Biosafety Committees and Regulation of Genetically Modified Organisms
14. Risk Assessments
PART II PRODUCT
15. Product Construction, Manufacture, and Process Validation
16. Analytical Method Development and Validation Leading to Control Strategy and Lot Release
PART Ill CLINICAL
17. Regulatory Aspects of Clinical Trials
18. Pharmacovigilance and RiskMAPs
19. Clinical Trial Ethics, Human Subjects Protections, and the Informed Consent process
20. Independent Ethics Committees and Institutional Review Boards
SECTION Ill PRODUCT-SPECIFIC REGULATORY PROCESSES
21. Biosimilars
22. In Vitro Diagnostics and Biotech Medical Devices
23. Combination Products
24. Regulatory Policy and Public Health Policy
