Full Description
The impact of regulation on drug development provides the reader with a basic understanding of the evolution of global regulatory standards relevant to the research and development process of medicinal products and the role regulatory science plays, i.e. the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of regulated products. This book provides practical guidance on how to obtain such advice efficiently and how it is incorporated in global regulatory planning and strategies.
Contents
Developing effective medicines - a contribution to public health; Evolution and maintenance of global regulatory standards; Current regulatory issues of research and development pipelines; The value chain from discovery to post-authorisation research; Health authorities provide scientific (and regulatory) advice; Strategic regulatory plans and planning.
