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Author: Maria Isabel Manley
Publisher:
ISBN: 9780191027888
Category :
Languages : en
Pages : 737
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Book Description
An authoritative and comprehensive analysis of EU pharmaceutical law and the most controversial legal issues within the innovative industry, supported by case studies and practical guidance.
Author: Maria Isabel Manley
Publisher:
ISBN: 9780191027888
Category :
Languages : en
Pages : 737
Get Book Here
Book Description
An authoritative and comprehensive analysis of EU pharmaceutical law and the most controversial legal issues within the innovative industry, supported by case studies and practical guidance.
Author: Maria Isabel Manley
Publisher: Oxford University Press, USA
ISBN: 9780198717997
Category : Law
Languages : en
Pages : 0
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Book Description
Patents / Dominic Adair, Greg Bacon, and Vanessa Rieu -- Clinical trials / Helen Middleton -- Procedures for obtaining a marketing authorisation and legal bases for application / Maria Isbel Manley and Libby Amos -- Pricing, reimbursement, and health technology appraisals (market access) / Maria Isabel Manley and Maria Georgiou -- Paediatrics / Georgia Gavriilidou -- Orphan drugs / Maria Isabel Manley and Chris Boyle -- Biological medicinal products and biosimilars / Dev Kumar and Lauren Wilks -- Regulatory data protection / Maria Isabel Manley and Grant Strachan -- Supplementary protection certificates / Maria Isabel Manley and Marina Vickers -- Maximisation of regulatory IP rights / Maria Isabel Manley and Marina Vickers -- The interaction between intellectual property law and competition law / Pat Treacy -- Access to information / Vincenzo Salvatore -- Litigating decisions of regulatory authorities / Kelyn Bacon, QC and Hugo Leith -- Pharmacovigilance / Maria Isabel Manley abd Edward Bray -- Data protection / Hazel Grant -- The promotion of medicinal products in the EU / Maria Isabel Manley and Libby Amos -- Borderline products / Maria Isabel Manley and Joanna Hook -- Product liability : the UK perspective / Mark Brown -- Pharmaceutical licensing and collaboration agreements : key consideration from the licensee's perspective / Jerry Temko -- Trade mark protection and enforcement in the pharmaceutical field / Sally Dunstan
Author: Sabrina Röttger-Wirtz
Publisher: Bloomsbury Publishing
ISBN: 1509943013
Category : Law
Languages : en
Pages : 288
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Book Description
This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.
Author: Wolf Sauter
Publisher: Edward Elgar Publishing
ISBN: 1802204415
Category : Law
Languages : en
Pages : 325
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Book Description
This timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control. It carefully considers the balance between competition and innovation, as well as between competition and regulation, and concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed.
Author: Pat Treacy
Publisher: Edward Elgar Publishing
ISBN: 178100689X
Category : Law
Languages : en
Pages : 555
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Book Description
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.
Author: Georgia A. Roussou
Publisher: Edward Elgar Publishing
ISBN: 1035309963
Category : Law
Languages : en
Pages : 267
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Book Description
This book explores whether the judicial developments related to the Supplementary Protection Certificate (SPC) regulation correspond to the objectives of the European legislator. Examining the role of SPCs for medicinal products in the European patent system, it highlights both the jurisprudence of the Court of Justice of the European Union and the respective judgements of the member states’ national courts.
Author: Frantzeska Papadopoulou
Publisher: Bloomsbury Publishing
ISBN: 1509950303
Category : Law
Languages : en
Pages : 368
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Book Description
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 developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.
Author: John Geigert
Publisher: Springer Nature
ISBN: 3031319095
Category : Science
Languages : en
Pages : 597
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Book Description
Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Author: Maurizio Borghi
Publisher: Taylor & Francis
ISBN: 1000830357
Category : Law
Languages : en
Pages : 370
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Book Description
This edited collection seeks to map the landscape of contemporary informational interests, to evaluate a range of recognised and putative rights and wrongs associated with modern information societies, and to consider how law, regulation, and governance should be deployed in response. New technologies and new applications constantly disrupt our values, our framing of our world, and our sense of where we are and who we are. In our ‘information societies’, we entertain mixed hopes and expectations, as well as significant fears and concerns. At the root of these, there are a number of informational interests, on the basis of which certain rights are claimed and particular wrongs denounced. This book addresses these interests, considering them as relating primarily to the integrity of the informational ecosystem, to the accessibility, accuracy, and authenticity of public information, and to our individual ability to control the outward and inward flows of information that relates directly to ourselves. Covering a wide range of subjects, the book’s interrogation of our contemporary information society is oriented around two questions: first, whether the information society in which we live is the kind of society that we think it should be and, second, if not, what we can reasonably expect law, regulation, and governance to do in providing the basis for improving it. This book will be of considerable interest to those working at the intersection of law and technology, as well as others concerned with the legal, political, and social aspects of our information society.
Author: Ilaria de Lisa
Publisher: Springer Nature
ISBN: 3030512061
Category : Law
Languages : en
Pages : 332
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Book Description
This book addresses Synthetic Biology (SynBio), a new and promising biotechnology that has attracted much interest from both a scientific and a policy perspective. Yet, questions concerning the patentability of SynBio inventions have not been examined in detail so far; as a result, it remains unclear whether these inventions are patentable on the basis of current norms and case law. The book addresses this question, focusing especially on the subject matter’s eligibility and moral criteria. It provides an overview of the legislation and decisions applicable to SynBio patents and examines this new technology in view of the ongoing debate over the patentability of biotechnologies in general. The legal analysis is complemented by the practical examination of several patent applications submitted to the European and US patent offices (EPO and USPTO), and by an assessment of the patent issues that are likely to be raised by future SynBio developments.
