CAPT Sheets (Retired)

Fundamentals of Biologicals Regulation (eBook, ePUB)

Vaccines and Biotechnology Medicines

• Format: ePub

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. 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.

• 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

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Produktdetails

• Verlag: Elsevier Science & Techn.
• Seitenzahl: 450
• Erscheinungstermin: 1. Dezember 2017
• Englisch
• ISBN-13: 9780128094433
• Artikelnr.: 50407091

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 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