This second edition of 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.

Originally published in 1987, this volume examines the ideals and realities of river use in 19th Century Britain and the failure of legal and technological remedies for river pollution. It deals with the involvement of scientists, particularly chemists, in pollution inquiries and considers the effects on the normal workings of the scientific community of scientists’ participation in the adversary forums in which water and sewage policy was made. It discusses 19th ideas of decomposition, disease causation and purification and examines the gap between the abilities of science and the needs of society that developed as the existence of water-borne disease became increasingly clear. It also deals with the politicization of water bacteriology and the emergence of a technology of biological sewage treatment from a political context.

Originally published in 1987, this volume examines the ideals and realities of river use in 19th Century Britain and the failure of legal and technological remedies for river pollution. It deals with the involvement of scientists, particularly chemists, in pollution inquiries and considers the effects on the normal workings of the scientific community of scientists’ participation in the adversary forums in which water and sewage policy was made. It discusses 19th ideas of decomposition, disease causation and purification and examines the gap between the abilities of science and the needs of society that developed as the existence of water-borne disease became increasingly clear. It also deals with the politicization of water bacteriology and the emergence of a technology of biological sewage treatment from a political context.

This second edition of 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.

Originally published in 1987, this volume examines the ideals and realities of river use in 19th Century Britain and the failure of legal and technological remedies for river pollution. It deals with the involvement of scientists, particularly chemists, in pollution inquiries and considers the effects on the normal workings of the scientific community of scientists’ participation in the adversary forums in which water and sewage policy was made. It discusses 19th ideas of decomposition, disease causation and purification and examines the gap between the abilities of science and the needs of society that developed as the existence of water-borne disease became increasingly clear. It also deals with the politicization of water bacteriology and the emergence of a technology of biological sewage treatment from a political context.

Originally published in 1987, this volume examines the ideals and realities of river use in 19th Century Britain and the failure of legal and technological remedies for river pollution. It deals with the involvement of scientists, particularly chemists, in pollution inquiries and considers the effects on the normal workings of the scientific community of scientists’ participation in the adversary forums in which water and sewage policy was made. It discusses 19th ideas of decomposition, disease causation and purification and examines the gap between the abilities of science and the needs of society that developed as the existence of water-borne disease became increasingly clear. It also deals with the politicization of water bacteriology and the emergence of a technology of biological sewage treatment from a political context.