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This updated and revised 2nd edition of Drug Benefits and Risks is an inclusive reference exploring the scientific basis and practice of drug therapy. The key concept is to look at the balance between the benefits and risks of drugs, but in this context also highlighting the social impact which drugs have in modern societies. Taking an evidence-based approach to the problem, the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world is examined. For this purpose the book covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases; the book gives guidance on how doctors should act so that drugs can be used effectively and safely; and it encourages the rational use of drugs in society. This publication brings together a large amount of excellent content that will be invaluable for anyone working within, or associated with, the field of clinical pharmacology and pharmacotherapy - undergraduates, postgraduates, regulatory authorities and the pharmaceutical industry.
This book develops a theoretical framework for examining and assessing the regulatory arrangements for medical products. Since the first half of the 20th century, the regulation of pharmaceuticals, medical devices and, more recently, biologicals have been controlled in many jurisdictions by specific regulatory regimes and agencies. Their regulatory mandates are similar – to ensure the quality, safety and efficacy of medical products. This book provides a timely and relevant assessment of the complexities of medical regulatory regimes, by drawing on a particular theory of political legitimacy. In this respect, the book adopts a ‘dialogic’ approach – according to which a shared set of ...
This cutting-edge book considers the functional inseparability of risk and innovation within the context of environmental law and governance. Analysing both ‘hard’ and ‘soft’ innovation, the book argues that approaches to socio-ecological risk require innovation in order for society and the environment to become more resilient.
In A Shot in the Arm, MIT Professor Yossi Sheffi recounts the extraordinary journey to deliver Covid-19 vaccines: from scientific advancements to candidate vaccines and mass vaccination. It is a story of bold innovation, risk-taking, and teamwork as scientists, engineers, supply chain experts, manufacturers, and governments collaborated on the greatest product launch in history. The book also highlights the breathtaking potential of revolutionary mRNA technology and the vital lessons for combating other global challenges, including climate change.
As the focus on pharmaceuticals has broadened from concern for their cost and effectiveness to their real and potential risks and benefits, a critical question has been raised: whose responsibility is it to improve drug safety? In April 1990, this question became the theme for a conference at Wolfsberg, Switzerland, near the shores of Lake Constance. Called an "international dialogue conference" by its organizers, the meeting brought together leaders from the pharmaceutical industry, regulatory authorities, academia, medicine, consumer organizations and the media. Opening addresses were given by representatives of the Council for International Organizations of Medical Sciences (CIOMS), the I...
This book provides new insights into how new biology, and the emergence of "translational" policies to drive the health bioeconomy, is reshaping the innovation ecosystem for new therapies. A key argument is that a broader definition of value (beyond the economic aspects) is needed to understand health innovation in the twenty-first century.
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On the backdrop of the institutionalisation of corporate social responsibility (CSR) and sustainability, and the emergence of multi-stakeholder-driven voluntary regulation, this timely collection places special emphasis on India and explores its international voluntary sustainability standards. The authors analyse the adoption and implementation of voluntary governance initiatives across a range of industries, offering insightful sectoral discussion and evaluation of voluntary sustainability standards as forms of transnational private regulation. This book will be of interest to anyone researching CSR, sustainability and supply chain management in emerging markets.