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.
1. Introduction - p. 3 2. Chapter 1: Introduction to the Regulatory Process for Biologicals - p. 3 3. Chapter 2: Discovery and Development - p. 18 4. Chapter 3: International Regulatory Convergence - p. 27 5. Chapter 4: Communications and Formal Meetings With Regulators: Focusing on the Process Before Clinical Trial Authorization (AKA PRE-IND) - p. 40 6. Chapter 5: Clinical Trial Authorization and Investigational New Drug Applications - p. 59 7. Chapter 6: Marketing Authorization - p. 77 8. Chapter 7: Alternative Regulatory Pathways and Special Programs - p. 98 9. Chapter 8: Variations or Changes to an Approved Application - p. 117 10. Chapter 9: Audits and Regulatory Compliance Inspections - p. 128 11. Chapter 10: Good “X” Practices - p. 143 12. Written Assignments Exercise - p. 159 13. Assignment Scenarios - p. 163 14. Section II: Regulatory Science - p. 166 15. Part I: Preclinical - p. 166 16. Chapter 11: Preclinical Safety and Toxicology - p. 166 17. Chapter 12: Preclinical Pharmacology, Proof-of-Principle - p. 196 18. Chapter 13: Institutional Biosafety Committees and Regulation of Genetically Modified Organisms - p. 208 19. Chapter 14: Risk Assessments - p. 218 20. Part II: Product - p. 229 21. Chapter 15: Product Construction, Manufacture, and Process Validation - p. 229 22. Chapter 16: Lot Release, Analytics, and Analytical Validation - p. 255 23. Part III: Clinical - p. 275 24. Chapter 17: Regulatory Aspects of Clinical Trials - p. 275 25. Chapter 18: Clinical Trial Ethics, Human Subjects Protections, and the Informed Consent Process - p. 316 26. Chapter 19: Independent Ethics Committees and Institutional Review Boards - p. 334 27. Section III: Product Specific - p. 341 28. Chapter 20: Biosimilars - p. 341 29. Chapter 21: In Vitro Diagnostics and Biotech Medical Devices - p. 358 30. Chapter 22: Regulatory Policy and Public Health Policy - p. 363 31. Glossary - p. 375 32. International Biologicals Regulation: Vaccines, Biotechnology Medicines By Rebecca L. Sheets Compilation of Weblinks - p. 391 33. Index - p. 415
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.
1. Introduction - p. 3 2. Chapter 1: Introduction to the Regulatory Process for Biologicals - p. 3 3. Chapter 2: Discovery and Development - p. 18 4. Chapter 3: International Regulatory Convergence - p. 27 5. Chapter 4: Communications and Formal Meetings With Regulators: Focusing on the Process Before Clinical Trial Authorization (AKA PRE-IND) - p. 40 6. Chapter 5: Clinical Trial Authorization and Investigational New Drug Applications - p. 59 7. Chapter 6: Marketing Authorization - p. 77 8. Chapter 7: Alternative Regulatory Pathways and Special Programs - p. 98 9. Chapter 8: Variations or Changes to an Approved Application - p. 117 10. Chapter 9: Audits and Regulatory Compliance Inspections - p. 128 11. Chapter 10: Good “X” Practices - p. 143 12. Written Assignments Exercise - p. 159 13. Assignment Scenarios - p. 163 14. Section II: Regulatory Science - p. 166 15. Part I: Preclinical - p. 166 16. Chapter 11: Preclinical Safety and Toxicology - p. 166 17. Chapter 12: Preclinical Pharmacology, Proof-of-Principle - p. 196 18. Chapter 13: Institutional Biosafety Committees and Regulation of Genetically Modified Organisms - p. 208 19. Chapter 14: Risk Assessments - p. 218 20. Part II: Product - p. 229 21. Chapter 15: Product Construction, Manufacture, and Process Validation - p. 229 22. Chapter 16: Lot Release, Analytics, and Analytical Validation - p. 255 23. Part III: Clinical - p. 275 24. Chapter 17: Regulatory Aspects of Clinical Trials - p. 275 25. Chapter 18: Clinical Trial Ethics, Human Subjects Protections, and the Informed Consent Process - p. 316 26. Chapter 19: Independent Ethics Committees and Institutional Review Boards - p. 334 27. Section III: Product Specific - p. 341 28. Chapter 20: Biosimilars - p. 341 29. Chapter 21: In Vitro Diagnostics and Biotech Medical Devices - p. 358 30. Chapter 22: Regulatory Policy and Public Health Policy - p. 363 31. Glossary - p. 375 32. International Biologicals Regulation: Vaccines, Biotechnology Medicines By Rebecca L. Sheets Compilation of Weblinks - p. 391 33. Index - p. 415
