Deze geheel herziene uitgave van het gelijknamige boek uit 2018 biedt nieuwe informatie en visualisaties, gaat in op actuele thema’s en heeft een nog duidelijkere indeling.
This book concerns the EU legal and regulatory framework relating to Chemicals in Food. It is divided in two parts: the first section offers an introduction to the European General Food Law with an analysis of EFSA (the European Food Safety Authority) and a description of main features of food safety-related regulations. Meer
As 1992 looms on the horizon and preparation is made for the completion of the internal market in Europe, the CMR realised the value of addressing some of the issues involved and defining the objectives and achievements of medicines regulations in a number of EEC countries in comparison with Japan and the USA. Meer
This book examines the position of children who provide tissue to potentially save the life of another. It questions whether child donors of all ages have been treated appropriately and whether they are sufficiently protected in acting as tissue donors, and ultimately considers whether a new regulatory response is needed to benefit donor children. Meer
This book focuses on reproductive health rights and assisted reproductive technologies (ART) in sub-Saharan Africa. Each chapter is connected to the other by focusing on different aspects of ART as a means of achieving conception. Meer
Diagnosis of death by neurological criteria (DNC) is a construct which has been part of the British medico-legal landscape for nearly half a century. This book examines the factors behind its emergence, and discusses the various changes that took place in the last few decades that culminated in the current definition and clinical criteria for determining brain-based death. Meer
At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory Authorities are concentrating on improving their efficiency and effectiveness. Meer
The Medicines Act 1968 together with its delegated legislation comprehensively controls the manufacture, packaging, labelling, distribution and promotion of medicines for both human and animal use in the United Kingdom. Meer
Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. Meer
This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. Meer
whether the patient is suffering? Should the ability to think and reason be considered as the most important factor? For instance, should a patient with Amyotrophic lateral sclerosis (ALS) who is mentally alert yet unable to move from the neck down be allowed to refuse medical treatment; and, if so, at what point in her treatment should one consider her life no longer worth living? Meer
This book is the first major work that addresses a core question in biomedical research: the question of acceptable risk. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law, which state that the risk and burden to the participant must be in proportion to potential benefits to the participant, society or science. Meer
First handbook in the market to cover regulatory affairs in Asia. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Meer
Die Medizin verrechtlicht sich vornehmlich auf untergesetzlichem Wege. Parallel hierzu ergehen Leitlinien unterschiedlicher Qualität und unterschiedlicher Institutionen. Meer
Das Buch richtet sich an Chirurgen, die in vertrauter Sprache und Form Antworten auf spezifische juristische Fragen und Probleme suchen. Die gemeinsame Erarbeitung durch einen Juristen und Chirurgen erlauben eine hohe Praxisrelevanz bei gleichzeitiger juristischer Genauigkeit. Meer
Das Buch richtet sich an Gynäkologen, die in vertrauter Sprache und Form Antworten auf spezifische juristische Fragen und Probleme suchen. Die gemeinsame Erarbeitung durch einen Juristen und Gynäkologen erlauben eine hohe Praxisrelevanz bei gleichzeitiger juristischer Genauigkeit. Meer
Der Embryonenschutz gehört zu den Schlüsselproblemen der Bioethik und hat durch die embryonale Stammzellenforschung zusätzliche Aktualität erhalten. Meer
Die Schrift stellt das Recht der Hochschulmedizin in seiner Gesamtheit dar. Der erste Teil geht auf die Grundlagen ein: den Begriff, die Aufgaben, die Entwicklung und das Verfassungsrecht als Ordnungsrahmen der Hochschulmedizin. Meer
Die Schadensregulierung im Bereich der Arzthaftung ist stetig Neuerungen ausgesetzt. Das führt zu erheblichen Problemen bei der Schadensberechnung, insbesondere im Hinblick auf die umfassenden Änderungen im Bereich des Schmerzensgeldes. Meer