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Guide to EU and UK Pharmaceutical Regulatory Law
In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unam...
The Impact of Patent Extensions in Access to Pharmaceuticals
This book critically assesses the development of pharmaceutical patent Term Extensions, and their impact; in particular, the practical impact on generic market entry. It focusses on European Supplementary Protection Certificates (SPCs), and the extent and effect on access to cheaper medication in terms of cost and availability. Policy making for pharmaceuticals requires considerations on availability and price. For developing countries, it appears impossible to form policy without promoting generic medicines, which are proven as an effective health care remedy to access and availability. A 20-year maximum patent term is generally recognised by originators to be insufficient. The European Uni...
WIPO ADR Options for Life Sciences Dispute Management and Resolution
This document has been developed by the WIPO Arbitration and Mediation Center (WIPO Center), as part of WIPO’s COVID-19 support package for member states. It takes into account input from WIPO Arbitrators and Mediators specialized in life sciences.
The Law of Off-label Uses of Medicines
This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarif...
The Decade in Tory
In 2020 the United Kingdom reached a bewildering milestone: ten successive years of Conservative rule. In that decade there were three prime ministers, each in turn described as the worst leader we ever had; ministerial resignations by the hundred; and an unrelenting stream of ineffectual, divisive bum-slurry oozing from 10 Downing Street. The Decade in Tory is an inglorious, rollicking and entirely true account of ten years of demonstrable lies, relentless incompetence, epic waste, serial corruption, official police investigations, anti-democratic practices, abuse of power, dereliction of duty and hundreds of thousands of avoidable deaths. With his signature scathing wit, Russell Jones breaks down the government’s interminable failures year by year, covering everything from David Cameron’s pledge to tackle inequality – which reduced UK life expectancy for the first time since 1841 – through the bewildering storm of lies and betrayals that led to Brexit, devastating education cuts, serial mismanagement of the NHS and Boris Johnson’s calamitous response to the Covid-19 pandemic. It will leave you gasping and wondering: can things possibly get any worse?
Guide to EU Pharmaceutical Regulatory Law
In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage...
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Evergreening Patent Exclusivity in Pharmaceutical Products
This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative d...
EU Competition Law and Intellectual Property Rights
This authoritative book from one of the top experts in the field sets out a detailed and practical analysis of the complex and often fraught relationship between EU competition rules and intellectual property rights. It is an essential resource for competition lawyers litigating Tech and Pharma cases and advising companies in those sectors, for in-house counsel within those industries, and for IP lawyers needing to understand the competition aspects of licensing agreements. It is also an indispensable reference for courts, enforcement agencies and national competition authorities, as well as for scholars researching in the field.
