Fundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation

Vaccines and Biotechnology Medicines

1st Edition - December 1, 2017

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  • Author: Rebecca Sheets
  • Paperback ISBN: 9780128092903
  • eBook ISBN: 9780128094433

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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


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

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

Product details

  • No. of pages: 450
  • Language: English
  • Copyright: © Academic Press 2017
  • Published: December 1, 2017
  • Imprint: Academic Press
  • Paperback ISBN: 9780128092903
  • eBook ISBN: 9780128094433

About the Author

Rebecca Sheets

• 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.

Affiliations and Expertise

Principal Consultant and Subject Matter Expert, Grimalkin Partners, Silver Spring, MD; Adjunct Professor, Catholic University of America

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