Fundamentals of Biologicals Regulation,
Edition 1 Vaccines and Biotechnology Medicines
By Rebecca Sheets, PhD, CAPT (Retired), USPHS

Publication Date: 01 Dec 2017

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.

Key Features

  • 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
About the author
By Rebecca Sheets, PhD, CAPT (Retired), USPHS, Principal Consultant and Subject Matter Expert, Grimalkin Partners, Silver Spring, MD and Adjunct Professor, Catholic University of America
Table of Contents

Section I: Regulatory Process

1. 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 Science

11. 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

Book details
ISBN: 9780128092903
Page Count: 450
Retail Price : £118.00
  • Singh, Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies, Jan 2015, 520 pp, 9780124166035, $200.00
  • Faqi, A Comprehensive Guide to Toxicology in Preclinical Drug Development, Nov 2012, 1024 pp, 9780123878151, $199.95
  • Plitnick, Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics, Jul 2013, 432 pp, 9780123948106, $174.95

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