Abstract
Abstract This book focuses on the science and regulatory policy and law surrounding the discovery, development, and marketing of new medicines. It reviews consumer protection and intellectual property laws that are applicable to the development and commercialisation of medicinal products. It also provides a deeper understanding of the scientific and technical issues for lawyers and legal issues for those involved with regulatory policy and decision-making, such as senior executives in the pharmaceutical industry. The book covers the European and UK legislation on medicines and healthcare products together with the UK implementing legislation and instruments, and key case law. It discusses the structure and function of the regulatory authorities, applications to carry out clinical trials, intellectual property issues, product liability issues, and litigation.
Published Version
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