Ter gelegenheid van zijn pensionering medio 2025 is in Quod non! een geheel nieuwe, actuele selectie opgenomen van door Oswald Nunes wekelijks gepubliceerde blogs.
Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. 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
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
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
The general scope of the book is the patentability and morality of human embryonic stem cell research in US, EU and China. The book observes fraudsters operate unsafe human embryonic stem cell therapies and officialdom turns a blind eye to the immoral human embryonic stem cell research in China. Meer
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Meer