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.

Dr. Rebecca Sheets is currently the Vice President for the International Alliance of Biologicals Standardization, North American affiliate. She is the former Vaccine Scientific and Regulatory Specialist at the National Institute of Allergy and Infectious Diseases. Dr. Sheets 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, she served as Co-Chair of the World Health Organization's Study Group on Cell Substrates and as Chair of the Adventitious Agents Sub-committee, as well as authoring several WHO guidelines and publications over the past two decades. She also taught for a decade at the Catholic University of America. Before retirement, she was the Principal Consultant at Grimalkin Partners from 2013-2021.

Section I: Regulatory Process1. Introduction2. Discovery and Development of Biologicals3. International Harmonization4. Pre-IND Profess, Guidance from Regulators in Advance of a Clinical Trials Application5. Clinical Trials Approvals and Investigational New Drug Applications6. Marketing Authorization Processes7. Special Regulatory Programs8. Post-Marketing Changes to an Approved Application or Variations9. Compliance and Inspections10. Good "X" Practices Section II: Regulatory Science11. Preclinical Safety and Toxicology12. Preclinical Proof-of-Concept and Pharmacology, Animal Use Ethics13. Genetically Modified Organisms and Institutional Biosafety Committees14. Risk Assessments15. Chemistry, Manufacturing, and Controls Information (CMC) and Process Validation16. Analytics, Analytical Validation, Lot Release, and National Control Laboratories17. Regulatory Aspects of Clinical Trials18. Ethics of Clinical Trials and the Informed Consent Process19. Institutional Review Board Processes (Ethics Committees)20. Biosimilars21. In Vitro Diagnostics22. Regulatory Policy and Public Health Policy