Guide To Eu Pharmaceutical Regulatory Law

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Guide to EU Pharmaceutical Regulatory Law

Author : Sally Shorthose
Publisher :
ISBN 13 : 9789041128454
Total Pages : 672 pages
Book Rating : 4.1/5 (284 download)

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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 . This book was released on 2010 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: This online version of this title will be shortly available atwww.kluwerlawonline.com.legislation, cases and customs which apply to the introduction, marketing andsale of a medicinal product (or a medical device) in Europe and to providesome clarity around the aforementioned complicated systems. It iswritten by and for lawyers, both in-house and in private practice, who findthemselves having to advise a client or clients on this ever-changing area oflaw, perhaps on the steps needed to bring a product to market including anysupplementary obligations (such as the need to conduct a clinical trial of theproduct for paediatric use), or perhaps when advising on clinical trialagreements, what “normal” rights and obligations of parties shouldbe included in the agreement. We hope the book will also be of interest andassistance to regulatory advisers. Each chapter presents a particularprocess or subject from a Europe-wide perspective. The chapters take thereader through the life of a medicinal product or medical device, fromdevelopment to clinical trials to product launch and afterwards, and weprovide guidance in matters where regulatory law is used as an instrument oflife-cycle management. With the exception of the advertising chapter,this book deals primarily with the European level of legislation. Where thereare significant national deviations or differences in interpretation, we havebeen able to take advantage of the breadth of Bird & Bird experience in anumber of major jurisdictions: ;UK, ;France, ;Germany, ;Spain, ;Belgium, ;TheNetherlands, ;Italy and ;Sweden tocreate national variations charts that appear at the end of certainchapters. These charts provide information on how the subject matter of thechapter is implemented in those eight major Member States, and they also serveto illustrate how implementation of the EU regulations varies between MemberStates. We have only included relevant or significant information so thelength of these appendices varies, and for some subjects, such as paediatrics,the legislation is so new and pan-European that we decided that no localvariation needed to be included. In addition, at the end of eachchapter we have included a list of guidelines/publications which will directthe readers to sources of additional information. European legislation ispeppered with acronyms. For help keeping them all straight, we included a listof the most commonly used ones in the pharmaceutical area, in addition tothose that appear in each chapter. This online version of this title will be shortly available atwww.kluwerlawonline.com.

Guide to EU and UK Pharmaceutical Regulatory Law

Author : Sally Shorthose
Publisher : Kluwer Law International B.V.
ISBN 13 : 9403530235
Total Pages : 840 pages
Book Rating : 4.4/5 (35 download)

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Book Synopsis Guide to EU and UK Pharmaceutical Regulatory Law by : Sally Shorthose

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.

The Interplay of Global Standards and EU Pharmaceutical Regulation

Author : Sabrina Röttger-Wirtz
Publisher : Bloomsbury Publishing
ISBN 13 : 1509943005
Total Pages : 417 pages
Book Rating : 4.5/5 (99 download)

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Book Synopsis The Interplay of Global Standards and EU Pharmaceutical Regulation by : Sabrina Röttger-Wirtz

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 417 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.

Navigating European Pharmaceutical Law

Author : Maria Isabel Manley
Publisher : Oxford University Press, USA
ISBN 13 : 9780198717997
Total Pages : 0 pages
Book Rating : 4.7/5 (179 download)

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Book Synopsis Navigating European Pharmaceutical Law by : Maria Isabel Manley

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

EU Pharmaceutical Regulation

Author : Govin Permanand
Publisher : Manchester University Press
ISBN 13 : 9780719072727
Total Pages : 272 pages
Book Rating : 4.0/5 (727 download)

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Book Synopsis EU Pharmaceutical Regulation by : Govin Permanand

Download or read book EU Pharmaceutical Regulation written by Govin Permanand and published by Manchester University Press. This book was released on 2006-09-05 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an analysis of European Union pharmaceutical regulation from a policy-making perspective. The focus is on how the often conflicting agendas of the pharmaceutical industry, the EU member states, the European Commission, and consumer interests are reconciled within the context of regulatory outcomes having to serve public health, healthcare and industrial policy needs within the single market. In providing a unique perspective on how and why EU pharmaceutical policy is made, the book will be of interest to academics, students and policy-practitioners interested in EU policy-making, regulation and public policy analysis.

Navigating European Pharmaceutical Law

Author : Maria Isabel Manley
Publisher :
ISBN 13 : 9780191027888
Total Pages : 737 pages
Book Rating : 4.0/5 (278 download)

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Book Synopsis Navigating European Pharmaceutical Law by : Maria Isabel Manley

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.

The Challenges of the New EU Pharmaceutical Legislation

Author : José Luis Valverde
Publisher : IOS Press
ISBN 13 : 9781586035211
Total Pages : 154 pages
Book Rating : 4.0/5 (352 download)

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Book Synopsis The Challenges of the New EU Pharmaceutical Legislation by : José Luis Valverde

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.

Medical Product Regulatory Affairs

Author : John J. Tobin
Publisher : John Wiley & Sons
ISBN 13 : 3527688986
Total Pages : 341 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Medical Product Regulatory Affairs by : John J. Tobin

Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2023-08-29 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.

Guide to EU Pharmaceutical Regulatory Law

Author : Sally Shorthose
Publisher : Kluwer Law International B.V.
ISBN 13 : 9041170022
Total Pages : 589 pages
Book Rating : 4.0/5 (411 download)

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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.

EU Law of Competition and Trade in the Pharmaceutical Sector

Author : Pablo Figueroa
Publisher : Edward Elgar Publishing
ISBN 13 : 1785362615
Total Pages : 758 pages
Book Rating : 4.7/5 (853 download)

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Book Synopsis EU Law of Competition and Trade in the Pharmaceutical Sector by : Pablo Figueroa

Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa and published by Edward Elgar Publishing. This book was released on 2019 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.

Pharmaceutical Regulation in Europe

Author : Panos Kanavos
Publisher :
ISBN 13 :
Total Pages : 56 pages
Book Rating : 4.:/5 (1 download)

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Book Synopsis Pharmaceutical Regulation in Europe by : Panos Kanavos

Download or read book Pharmaceutical Regulation in Europe written by Panos Kanavos and published by . This book was released on 2002 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Rules and Guidance for Pharmaceutical Distributors (Green Guide) 2017

Author : Medicines and Healthcare products Regulatory Agency
Publisher :
ISBN 13 : 9780857112866
Total Pages : 352 pages
Book Rating : 4.1/5 (128 download)

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Book Synopsis Rules and Guidance for Pharmaceutical Distributors (Green Guide) 2017 by : Medicines and Healthcare products Regulatory Agency

Download or read book Rules and Guidance for Pharmaceutical Distributors (Green Guide) 2017 written by Medicines and Healthcare products Regulatory Agency and published by . This book was released on 2017-01-06 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: A single source of guidance to, and legislation for, the distribution of medicines in Europe and UK.

Pharmacy Law and Practice

Author : Jon Merrills
Publisher : Academic Press
ISBN 13 : 0123946182
Total Pages : 570 pages
Book Rating : 4.1/5 (239 download)

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Book Synopsis Pharmacy Law and Practice by : Jon Merrills

Download or read book Pharmacy Law and Practice written by Jon Merrills and published by Academic Press. This book was released on 2013-04-19 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fifth edition of Pharmacy Law and Practice provides a straightforward and useable guide for students, practitioners, academics and others interested in pharmacy law and practice in the United Kingdom. This multi-dimensional book includes discussions of socio-political influences on legal developments to provide greater insight to the reader. It clearly sets out the background to regulatory issues together with simple and practical statements of what a pharmacist has to do to obey the law. As in previous editions, this book discusses topics thematically rather than by statute. It is a unique and reader-friendly guide that boils down the complex or difficult language of the law, describes the reasons behind it, and illustrates the application to pharmacy practice. Thoroughly updated to reflect regulatory and legal developments in areas including employment law, online transactions and internet pharmacies, non-medical prescribing and more Takes an intuitive, problem-solving approach and discusses topics thematically rather than by statute to show how all of the larger pieces fit together The electronic version of this book contains valuable links to provide readers with the most current information in a rapidly changing subject area

The Interplay of Global Standards and EU Pharmaceutical Regulation

Author : Sabrina Röttger-Wirtz
Publisher : Bloomsbury Publishing
ISBN 13 : 1509943013
Total Pages : 288 pages
Book Rating : 4.5/5 (99 download)

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Book Synopsis The Interplay of Global Standards and EU Pharmaceutical Regulation by : Sabrina Röttger-Wirtz

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.

Fundamentals of EU Regulatory Affairs

Author : Raps
Publisher :
ISBN 13 : 9780982932100
Total Pages : 372 pages
Book Rating : 4.9/5 (321 download)

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Book Synopsis Fundamentals of EU Regulatory Affairs by : Raps

Download or read book Fundamentals of EU Regulatory Affairs written by Raps and published by . This book was released on 2002-06-30 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Global Pediatric Development of Drugs, Biologics, and Medical Devices

Author : Jocelyn Jennings
Publisher :
ISBN 13 : 9781947493735
Total Pages : pages
Book Rating : 4.4/5 (937 download)

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Book Synopsis Global Pediatric Development of Drugs, Biologics, and Medical Devices by : Jocelyn Jennings

Download or read book Global Pediatric Development of Drugs, Biologics, and Medical Devices written by Jocelyn Jennings and published by . This book was released on 2021-11-26 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2022

Author : Medicines and Healthcare Products Regulatory Agency
Publisher :
ISBN 13 : 9780857114396
Total Pages : 1140 pages
Book Rating : 4.1/5 (143 download)

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Book Synopsis Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2022 by : Medicines and Healthcare Products Regulatory Agency

Download or read book Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2022 written by Medicines and Healthcare Products Regulatory Agency and published by . This book was released on 2022-03-07 with total page 1140 pages. Available in PDF, EPUB and Kindle. Book excerpt: