Seems you have not registered as a member of localhost.saystem.shop!
You may have to register before you can download all our books and magazines, click the sign up button below to create a free account.
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...
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...
Drugs Law and Legal Practice in Southeast Asia
Drugs Law and Legal Practice in Southeast Asia investigates criminal law and practice relevant to drugs regulation in three Southeast Asian jurisdictions: Indonesia, Singapore and Vietnam. These jurisdictions represent a spectrum of approaches to drug regulation in Southeast Asia, highlighting differences in practice between civil and common law countries, and between liberal and authoritarian states. This book offers the first major English language empirical investigation and comparative analysis of regulation, jurisprudence, court procedure, and practices relating to drugs law enforcement in these three states.
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.
Take Pride: How to Build Organisational Success Through People
In the UK, only one in three employees say they love their jobs and as many don’t give a damn. Sheila Parry, strategic communications consultant to some of the world's best-known brands, aims to change that. This book launches her PRIDE model, a methodology based around five key motivators: Purpose, Reputation, Integrity, Direction and Energy. Building pride at work delivers higher performance, improves brand reputation and strengthens customer loyalty. It also increases innovation, quality, productivity and profit. And those who are more fulfilled at work tend to achieve more and lead happier, healthier lives. Take Pride distills forty years of experience into a practical business philosophy: it is the perfect toolkit for leaders and influencers who have the imagination to think and desire to think differently about work.
Law and Economics of Public Procurement Reforms
Appropriate laws and regulations are essential tools to direct the action of procurers toward the public good and avoid corruption and misallocation of resources. Common laws and regulations across regions, nations and continents potentially allow for the further opening of markets and ventures to newcomers and new ideas to satisfy public demand. Law and Economics of Public Procurement Reforms collects the original contributions related to the new European Union Directives approved in 2014 by the EU Parliament. They are of both economists and lawyers, and have been presented in a manner that allows for exchanges of views and "real time" interaction. This book features, for each section, an i...
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...
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?
