Download or read book An Introduction to EU Pharmaceutical Law written by John Lisman and published by . This book was released on 2005 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book An Atlas of Surgical Exposures of the Upper and lower Extremities written by Raoul Tubiana and published by CRC Press. This book was released on 2000-04-03 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt: This concise volume contains the essential information an orthopaedic surgeon needs for safe access to the internal structures of the limbs for the whole range of orthopaedic operations.
Download or read book Guide to Eu Pharmaceutical Regulatory Law written by Sally Shorthose and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fully revised and updated, this practical book contains information on the processes, legislation, cases and customs that apply to the introduction, marketing and sale of a medicinal product (or medicinal device) in Europe. 00Pharmaceutical regulatory law is becoming ever more complicated, with the need to balance the constitutional requirements of the EU and its constituent Member States. This work, written by and for lawyers, will help you advise your clients on this constantly changing area. 00The new edition provides you with information on the changes to clinical trials, pharmacovigilance and competition law, helping you stay abreast of new legislation. 00Adopting 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, providing you with comprehensive and unambiguous guidance at every stage. 00Comprising three main sections, you’ll find the mainstream medicinal products from cradle to grave; specific regimes which do not fall into those categories; and three standalone chapters, dealing with an overview of what a medical device is, parallel trade, and competition law. 00Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of 15 incisive chapters examines a particular process or subject.
Download or read book Guide to EU and UK Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International B.V.. This book was released on 2023-01-10 with total page 840 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials 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.
Download or read book The Interplay of Global Standards and EU Pharmaceutical Regulation written by Sabrina Röttger-Wirtz and published by Bloomsbury Publishing. This book was released on 2021-08-26 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Navigating European Pharmaceutical Law written by Maria Isabel Manley and published by Oxford University Press, USA. This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book The Challenges of the New EU Pharmaceutical Legislation written by José Luis Valverde and published by IOS Press. This book was released on 2005 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the domain of public policy on pharmaceuticals, protecting public health requires a dual strategy: robust regulation on the one hand and stimulation of competitiveness and innovation on the other. Regulation must be robust to ensure that only medicines meeting exact standards of safety, quality and efficacy are authorised for human and animal use. At the same time competitiveness and innovation must be stimulated. Without innovation in pharmaceuticals, the incurable diseases of today will remain incurable. Competitiveness drives innovation and innovation saves lives. Increased competitiveness of the pharmaceutical sector will not only better protect public health, but will also create high quality jobs and create growth. In this context the implementation of the G10 recommendations, particularly regarding the pricing and reimbursement of medicines by Member States, remains a considerable challenge.
Download or read book Navigating European Pharmaceutical Law written by Maria Isabel Manley and published by . This book was released on 2015 with total page 737 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmaceuticals in the European Union written by Giuditta Savonitto and published by Cambridge Scholars Publishing. This book was released on 2019-04-23 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers the first complete and up-to-date analysis of the European Union’s regulation of medicines. Through a reasoned description ranging from regulatory developments to the jurisprudence of the Court of Justice of the European Union, it delineates the current European pharmaceutical regulation system. Moreover, the economic and social implications caused by the market fragmentation linked to disparities in national pricing and reimbursement schemes of pharmaceuticals are also explored here. In what was theorized to be a patchwork of rules and roles, the potential growth of the pharmaceutical industry is hampered and important inequalities in patient access are growing. What will be the next moves of European Union legislation to address the aging of the population, the higher incidence of some diseases and the growing costs of innovative medicines? Answers to such questions are offered in this book.
Download or read book European Regulation of Medical Devices and Pharmaceuticals written by Nupur Chowdhury and published by Springer Science & Business. This book was released on 2014-04-29 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.
Download or read book EudraBook written by and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 2015 marks the 50th anniversary of pharmaceutical legislation in the EU, which began with Directive 65/65 in 1965 in the wake of the Thalidomide disaster. The EU legal framework for medicinal products for human use guarantees high standards of quality and safety of medicinal products and intends to promote the functioning of the internal market, with measures which encourage innovation and competiveness in Europe. It is based on the principle that medicinal products may be placed on the market only following a marketing authorisation granted by the competent authorities. A large body of legislation has developed around this principle, with the progressive harmonisation of requirements for the granting of marketing authorisations since the 1960s, implemented across the whole European Economic Area. Nowadays, medicinal products may be either authorised centrally by the European Commission or nationally by Member States' competent authorities.^The European Medicines Agency, established in 1995, underpins the centralised authorisation procedure and supports coordination between national competent authorities. The Agency is the hub of a European medicines network comprising over 40 national regulatory authorities guaranteeing a constant exchange and flow of information regarding the scientific assessment of medicinal products in the EU. The EU legal framework is definitely not an area in which the law stands still. Quite the contrary, its history is marked by a constant ambition to improve its functioning or tackling shortcomings in order to guarantee the right balance between early access of patients to new medicines and high standards of quality and safety. Moreover, over the past 50 years science has developed. New technologies and further knowledge about diseases led to the introduction of new concepts or re-shaping of existing medical therapies that were subsequently mirrored in legislation.^The pharmaceutical sector is characterised by an abundance of guidelines intended to help and support the key players in the application of the EU legal framework. Still, the guidance documents would be nothing without the basic legislation on which they build. To understand the EU legal framework for medicinal products it is important to know the applicable provisions of the legislation itself. This E-Book is intended to support readers in this regard by putting together the most recent versions of the key legal instruments on medicinal products for human use. It provides a useful overview for stakeholders, especially the pharmaceutical industry, regulatory authorities, legal practitioners, but also interested citizens, patients and healthcare professionals.
Download or read book New Developments of Pharmaceutical Law in the EU written by J. L. Valverde and published by Ios PressInc. This book was released on 2010-01-01 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book European Union Health Law written by Tamara K. Hervey and published by Cambridge University Press. This book was released on 2015-11-12 with total page 749 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first holistic and thematic study of EU health law, and its implications, through its own internal logics.
Download or read book Eu Pharmaceutical Law written by Peter Bogaert and published by . This book was released on 2003 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Download or read book European Union Pharmaceutical Legislation Handbook written by USA International Business Publications and published by International Business Publications USA. This book was released on 2010-01 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: EU Medical and Pharmaceutical Industry Legislation Handbook. Vol. 4 Legislation on Medical Devices...
Download or read book Competition Law and IP Rights in Pharmaceuticals and Biotechnology written by Björn Lundqvist and published by Oxford University Press, USA. This book was released on 2031-05-30 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive analysis of European competition law and intellectual property law issues affecting the pharmaceutical and biotechnology sectors, offering both theoretical and practical perspectives.
