Rebecca Sheets, Kathryn C Zoon, Mark Schenerman, Susan Neadle, Christopher Hamlin, Ivana Knezevic, Mehmet Tosun

Fundamentals of Biologicals Regulation

Vaccines and Biotechnology Medicines

• Broschiertes Buch

Produktbeschreibung

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. In this new edition the book provides more in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans and REMS, and switching from reliance on in vivo to in vitro analytical methods. This new edition also reflects the new developments and processes accelerated by the COVID-19 vaccine experience, including emergency use authorizations and conditional marking authorizations. New pedagogic elements and case studies have been added to improve learning outcomes for students. This book provides 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 emphasis on the European Medicines Agency and the U.S. Food and Drug Administration. Graduate students will benefit from the new pedagogic features. Regulatory professionals will have in Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines a complete guide to navigate through the approval process.

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Produktdetails

• Verlag: Elsevier Science
• 2nd edition
• Seitenzahl: 450
• Erscheinungstermin: 1. Juli 2025
• Englisch
• ISBN-13: 9780443219887
• ISBN-10: 0443219885
• Artikelnr.: 72066601

Autorenporträt

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.

Inhaltsangabe

SECTION I REGULATORY PROCESS 1. Introduction to the Regulatory Process for
Biologicals 2. International Regulatory Convergence 3. Quality by Design
(QbD) Approach to Discovery and Development 4. Communications and Formal
Meetings With Regulators: Focusing on the Process Before Clinical Trial 5.
Clinical Trial Authorization and investigational New Drug Applications 6.
Marketing Authorization 7. Alternative Regulatory Pathways and Special
Programs 8. Variations or Changes to an Approved Application 9. Good "X"
Practices 10. Audits and Regulatory Compliance inspections SECTION II
REGULATORY SCIENCE PART I PRECLINICAL 11. Preclinical Safety and Toxicology
12. Preclinical Pharmacology , Proof-of-Principle 13. Institutional
Biosafety Committees and Regulation of Genetically Modified Organisms 14.
Risk Assessments PART II PRODUCT 15. Product Construction, Manufacture, and
Process Validation 16. Analytical Method Development and Validation Leading
to Control Strategy and Lot Release PART Ill CLINICAL 17. Regulatory
Aspects of Clinical Trials 18. Pharmacovigilance and RiskMAPs 19. Clinical
Trial Ethics, Human Subjects Protections, and the Informed Consent process
20. Independent Ethics Committees and Institutional Review Boards SECTION
Ill PRODUCT-SPECIFIC REGULATORY PROCESSES 21. Biosimilars 22. In Vitro
Diagnostics and Biotech Medical Devices 23. Combination Products 24.
Regulatory Policy and Public Health Policy