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Eu Law And Life Sciences
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Book Synopsis Eu Law and Life Sciences by : Peter Bogaert
Download or read book Eu Law and Life Sciences written by Peter Bogaert and published by . This book was released on 2014 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume comprises 12 chapters authored by Covington & Burling lawyers. These chapters cover key areas of EU law that impact the life sciences industry, including the specific regulatory obligations that apply to life sciences companies, EU competition rules, EU data protection rules and the laws governing bribery. Each chapter is authored by one or several leading specialists of the subject matter discussed. EU Law and Life Sciences aims at providing in house counsel in life sciences firms, regulators, and lawyers with a comprehensive view of the complex set of rules that affect the business of life sciences companies. It combines theoretical insights with practical advice.
Book Synopsis The Life Sciences in European Union Law by : Sophie Bisson
Download or read book The Life Sciences in European Union Law written by Sophie Bisson and published by . This book was released on 2017-09-24 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: In just a few decades the life sciences sector has witnessed considerable advances that have made 'life' accessible, tangible, and available for use in increasingly diversified forms, for ever more sophisticated applications in the research and development context or outside the laboratory. Whether they went out the lab door a long time ago or not, these various forms now share the particularity of being handled, transformed or otherwise valued in highly regulated environments; a common feature deserving consideration in the light of European Union law since many of its rules in the sector have themselves proven malleable enough to embrace both the multi-faceted, transnational challenges of technological change and its huge potential. The present book endeavours to explain how, and to what extent, the European integration process has been, and still is, able to provide a flexible basis for overcoming these challenges in a multi-level system of governance. With a vision resolutely turned toward the future, it also leaves space for reflection about the possible paths European lawyers could take in what is now a technologically open world. This book is intended for lawyers who are specialising in EU law and in international law, or who wish to open up new horizons in their respective fields of specialisation. It could be of particular interest to the younger generations of lawyers, to which the author herself belongs. It is also aimed at all scientific students, life scientists and any other persons who are already familiar with the intricacies of EU law.
Book Synopsis A User's Guide to Intellectual Property in Life Sciences by : Paul England
Download or read book A User's Guide to Intellectual Property in Life Sciences written by Paul England and published by Bloomsbury Publishing. This book was released on 2021-04-08 with total page 877 pages. Available in PDF, EPUB and Kindle. Book excerpt: Life Sciences is one of the most innovative and complex areas of law. It is currently undergoing a period of intense transformation, with companies facing an ever-increasing level of regulation as well as strict cost management in order to remain competitive and profitable. The latest in "A User's Guide to..." series it covers life sciences in relation to: - patents - copyright - trade marks; and - data protection The book covers UK law with references to significant EPO cases. A key part of the book is the coverage of case law. Case studies and detailed analysis of the key cases, eg the Kymab mouse case, the human genome sciences case, and the pregabalin case feature heavily helping to put this often complex area of law into context. Where appropriate and for comparison purposes, approaches of key foreign jurisdictions are summarised and for ease of use there are clearly signposted. A key text for practitioners specialising in life sciences and intellectual property in general and patents officers dealing with life sciences applications.
Book Synopsis LIFE SCIENCES AND INTELLECTUAL PROPERTY. by : BIRD & BIRD. LLP
Download or read book LIFE SCIENCES AND INTELLECTUAL PROPERTY. written by BIRD & BIRD. LLP and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Intellectual Property Rights and the Life Science Industries by : Graham Dutfield
Download or read book Intellectual Property Rights and the Life Science Industries written by Graham Dutfield and published by World Scientific. This book was released on 2009 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a highly readable and entertaining account of the co-evolution of the patent system and the life science industries since the mid-19th century. The pharmaceutical industries have their origins in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, as have the lobbying activities of the firms involved and their supporters in the legal profession. In turn, patent law has impacted on the life science industries. Compared to the first edition, which told this story for the first time, the present edition focuses more on specific businesses, products and technologies, including Bayer, Pfizer, GlaxoSmithKline, aspirin, penicillin, monoclonal antibodies and polymerase chain reaction. Another difference is that this second edition also looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology, which promises to enable scientists to OC inventOCO life forms from scratch.
Book Synopsis Big Data in the Health and Life Sciences by : Timo Minssen
Download or read book Big Data in the Health and Life Sciences written by Timo Minssen and published by . This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The relevance of big data is not limited to applications in the information technology sector but extends to other important technological fields, such as the increasingly data-driven health and life sciences. Timo Minssen and Jens Schovsbo introduce some of the challenges resulting from the intersection between big data and competition law in health and life sciences. With a focus on European competition law, they describe the increasing relevance of big data and the protection of data in health and life sciences, how these developments relate to European competition law, and what and where the main challenges are. Minssen and Schovsbo consider imperative that the legal issues raised by big data and artificial intelligence are given the highest priority by the European Commission, and they welcome that the Commission devotes efforts and resources to address competition aspects of big data and privacy in order to test whether its jurisdictional criteria are still adequate.
Book Synopsis Digital Finance in Europe: Law, Regulation, and Governance by : Emilios Avgouleas
Download or read book Digital Finance in Europe: Law, Regulation, and Governance written by Emilios Avgouleas and published by Walter de Gruyter GmbH & Co KG. This book was released on 2021-12-20 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: Global finance is in the middle of a radical transformation fueled by innovative financial technologies. The coronavirus pandemic has accelerated the digitization of retail financial services in Europe. Institutional interest and digital asset markets are also growing blurring the boundaries between the token economy and traditional finance. Blockchain, AI, quantum computing and decentralised finance (DeFI) are setting the stage for a global battle of business models and philosophies. The post-Brexit EU cannot afford to ignore the promise of digital finance. But the Union is struggling to keep pace with global innovation hubs, particularly when it comes to experimenting with new digital forms of capital raising. Calibrating the EU digital finance strategy is a balancing act that requires a deep understanding of the factors driving the transformation, be they legal, cultural, political or economic, as well as their many implications. The same FinTech inventions that use AI, machine learning and big data to facilitate access to credit may also establish invisible barriers that further social, racial and religious exclusion. The way digital finance actors source, use, and record information presents countless consumer protection concerns. The EU’s strategic response has been years in the making and, finally, in September 2020 the Commission released a Digital Finance Package. This special issue collects contributions from leading scholars who scrutinize the challenges digital finance presents for the EU internal market and financial market regulation from multiple public policy perspectives. Author contributions adopt a critical yet constructive and solutions-oriented approach. They aim to provide policy-relevant research and ideas shedding light on the complexities of the digital finance promise. They also offer solid proposals for reform of EU financial services law.
Book Synopsis Research Handbook on Intellectual Property and the Life Sciences by : Duncan Matthews
Download or read book Research Handbook on Intellectual Property and the Life Sciences written by Duncan Matthews and published by Edward Elgar Publishing. This book was released on 2017-06-30 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Intellectual property (IP) is a key component of the life sciences, one of the most dynamic and innovative fields of technology today. At the same time, the relationship between IP and the life sciences raises new public policy dilemmas. The Research Handbook on Intellectual Property and the Life Sciences comprises contributions by leading experts from academia and industry to provide in-depth analyses of key topics including pharmaceuticals, diagnostics and genes, plant innovations, stem cells, the role of competition law and access to medicines. The Research Handbook focuses on the relationship between IP and the life sciences in Europe and the United States, complemented by country-specific case studies on Australia, Brazil, China, India, Japan, Kenya, South Africa and Thailand to provide a truly international perspective.
Book Synopsis Protecting and Enforcing Life Science Inventions in Europe by : Bernd Allekotte
Download or read book Protecting and Enforcing Life Science Inventions in Europe written by Bernd Allekotte and published by Nomos Verlagsgesellschaft. This book was released on 2015-01-30 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dieses Handbuch, das speziell auf die Informationsbedurfnisse des Patentanmelders zugeschnitten ist, stellt in englischer Sprache Moglichkeiten, Reichweite und Verfahren des Schutzes und der Durchsetzung von Erfindungen im Sektor Biotechnologie/Life Sciences dar. Zum Verstandnis erforderliche naturwissenschaftliche Grundlagen werden speziell im Zusammenhang mit der Schutzfahigkeit fundiert miterlautert. Die reichhaltigen Fallbeschreibungen und anderen Materialien tragen dazu bei, dass das Werk in seinem Bereich unentbehrlich ist.
Book Synopsis Guide to EU Pharmaceutical Regulatory Law by : Sally Shorthose
Download or read book Guide to EU Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International B.V.. This book was released on 2017-02-17 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and ‘essential similarity’; - paediatric use and the requisite additional trials; - biologicals and ‘biosimilars’; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Book Synopsis An Introduction to Genetic Engineering, Life Sciences and the Law by : George Wei
Download or read book An Introduction to Genetic Engineering, Life Sciences and the Law written by George Wei and published by NUS Press. This book was released on 2002 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: The moral, social, economic and legal issues raised by work in the life sciences are immense. These include the legal issues that concern the use and abuse of genetic information. This book is an introductory survey of the relations between the life sciences and the law.
Book Synopsis European Company Law by : Andrea Vicari
Download or read book European Company Law written by Andrea Vicari and published by Walter de Gruyter GmbH & Co KG. This book was released on 2021-03-08 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book provides students of European company law courses, scholars and practitioners with an overview. Although company law remains mainly regulated at the level of national laws, it has become important to obtain a systematic view of the main directives in the field of company law, the EU Court of Justice’s jurisprudence, the European Model Company Act and the state of implementation of these directives in the member states of the Union. The book therefore contains, in addition to the illustration of the law laid down by EU legislative bodies and the related soft laws, detailed references to the most important domestic legislations and case laws, in order to make them known and usable as much as possible. Moreover, the book allows identifying the most relevant current legislative trends and the main historical reasons for divergences.
Book Synopsis Commercial Issues for the Life Sciences Company by : Paul M. Taylor
Download or read book Commercial Issues for the Life Sciences Company written by Paul M. Taylor and published by . This book was released on 2000 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tackles the main commercial and legal issues that a bioscience company could face in its lifetime. This title takes the business manager through issues and events within a company and in the day-to-day running of the business. It is intended as a hands-on guide.
Book Synopsis Intellectual Property in the Life Sciences by : Paul England
Download or read book Intellectual Property in the Life Sciences written by Paul England and published by Globe Law and Business Limited. This book was released on 2011 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: It uniquely satisfies two practical needs: a global reach that reflects the worldwide markets within which the life sciences industry now operates, and a sector-based approach addressing the issues that those in the business face. Written by a team of the world's leading specialists in the field, including Lewis Ho from Simmons & Simmons, Joachim Feldges from Field Fisher Waterhouse, Miquel Montana from Clifford Chance and Pravin Anand from Anand and Anand, this accessible guide provides an overview of the key international and European IP legislation, complementing the book's central theme of monopoly protection. In addition, the book features coverage from 15 jurisdictions of the most important and topical life sciences issues on which intellectual property has an impact.
Book Synopsis Protecting and Enforcing Life Science Inventions in Europe by : Franz-Josef Zimmer
Download or read book Protecting and Enforcing Life Science Inventions in Europe written by Franz-Josef Zimmer and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis European Union Law and Forms of Life by : Loïc Azoulai
Download or read book European Union Law and Forms of Life written by Loïc Azoulai and published by Hart Publishing. This book was released on 2020-08-06 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: A shift is taking place in the self-description of the European integration project. There is a notion that the Union is more than an elaborate institutional machinery. This shift responds to a particular context : the Union is currently facing an "existential crisis". Given this, it is vital to consider European integration as a way to structure or deconstruct modes of existence and modes of coexistence. How do we grasp existential Europe? How do we explore the social practices, individual dispositions, sentiments and beliefs lying beyond the institutional façade of the European Union's crises? This volume will address these questions by understanding European law, and EU law in particular, as one of the main social practices which forms our lives in Europe. It will seek to examine the ways in which European law shapes and interconnects with the individual's relationship to Europe, political forms and social forms. This thoughtful and reflective book offers an important response to the current upheavals in the EU and EU law.
Book Synopsis Legal Capital in Europe by : Marcus Lutter
Download or read book Legal Capital in Europe written by Marcus Lutter and published by Walter de Gruyter. This book was released on 2006 with total page 716 pages. Available in PDF, EPUB and Kindle. Book excerpt: Europe has known very different systems of company laws for a long time. These differences do not only pertain to the board structures of public companies, where single-tier and two-tier structures can be distinguished, they also pertain to the principles of fixed legal capital. Fixed legal capital is not a traditional ingredient of English and Irish company law and had to be incorpo-rated into these legal systems (only) for public limited companies according to the Second European Company Law Directive of 1976. Both jurisdictions have never really embraced these rules. Against this background, the British Accounting Standards Board (ASB) and the Company Law Centre at the British Institute of International and Comparative Law (BIICL) have initiated and supported a study of the benefits of this legal system by a group of experts led by Jonathan Rickford. The report of this group has been published in 2004. Its result was that legal capital was costly and superfluous; hence, the Second Directive should be repealed. The British government has adopted this view and wants the European Commission to act accordingly. Against this background a group of German and European company law experts, academics as well as practitioners, have come together to scrutinise sense and benefits of fixed legal capital and all its specific elements guided by the following questions: What is the relevant legal concept supposed to achieve? What does it achieve in reality? What criticisms are there? Which proposals or alternatives are available? From the outset the group of experts has endeavoured to cooperate with foreign colleagues, which resulted in very fruitful and pleasant exchanges. This volume contains, besides an executive summary of the results, 16 essays on specific aspects of legal capital in Germany covering also neighbouring fields of law (e.g. accounting, insolvency);7 reports on fixed legal capital in other jurisdictions (France, Great Britain, Italy, the Netherlands, Poland, Spain and the U.S.A.) addressing the same questions as the essays on German law. The British initiative disapproves of the Second Directive. The Directive does only deal with public limited companies in Europe, which is reflected in the analysis presented here. It is only concerned with the fixed legal capital of public limited companies, not with capital issues of private companies. The study has arrived at a result that differs completely from that of the Rickford group. It verifies the usefulness of the concept of fixed legal capital and wishes to convince the European Commission of the benefits of the Second Company Law Directive.