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.
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Table of Contents
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
Authors
Rebecca Sheets Principal Consultant and Subject Matter Expert, Grimalkin Partners, Silver Spring, MD; Adjunct Professor, Catholic University of America. . Currently a board member and Executive Committee Member (Vice President for Human Biologicals) of the International Alliance of Biologicals Standardization. Former Vaccine Scientific and Regulatory Specialist at the National Institute of Allergy and Infectious Diseases
. Served 9 years as a Scientific Reviewer in the Viral Vaccines branch of the Division of Vaccines and Related Products Applications at the Center for Biologics Evaluation and Research at the FDA
. From 2006-2014, served as Co-Chair of the World Health Organization's Study Group on Cell Substrates and as Chair of the Adventitious Agents Sub-committee.
