Fundamentals of EU Regulatory Affairs, 9th Edition PDF Download
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Author: Gloria Hall
Publisher:
ISBN: 9781947493438
Category :
Languages : en
Pages :
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Author: Gloria Hall
Publisher:
ISBN: 9781947493438
Category :
Languages : en
Pages :
Get Book Here
Book Description
Author: Raps
Publisher:
ISBN: 9780982932100
Category : Biologicals
Languages : en
Pages : 372
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Book Description
Author: Mujadala Abdul-Majid
Publisher:
ISBN: 9780982932018
Category : Biologicals
Languages : en
Pages : 414
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Book Description
Author: Frank Nellen
Publisher: Kluwer Law International B.V.
ISBN: 9403523441
Category : Law
Languages : en
Pages : 661
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Book Description
Parties to cross-border disputes arising anywhere in the vast Portuguese-speaking world – a community of more than 230 million in a space that offers a wide array of investment opportunities across four continents – increasingly seek Portugal as their preferred seat of arbitration. A signatory to all relevant international conventions, Portugal has proven to be an ‘arbitration-friendly’ jurisdiction. This volume is the first and so far only book in English that provides a thorough, in-depth analysis of international arbitration law and practice in Portugal. Its contributing authors are among the most highly regarded legal names in the country, including scholars, arbitrators, and practitioners. The authors describe how international arbitration proceedings are conducted in Portugal, what cautions should be taken, and what procedural strategies may be suitable in particular cases. They provide insightful answers to questions such as the following: What matters can be submitted to arbitration under Portuguese law? What are the validity requirements for an arbitration agreement? How do the State courts interact with arbitration proceedings and what is the attitude of such courts toward international arbitration? What are the rules governing evidentiary matters in arbitration? How is an arbitration tribunal constituted? How are arbitrators appointed? How may they be challenged? How can an international arbitral award be recognized and enforced? How does the Portuguese legal system address the issue of damages and what specific damages are admitted? How are the costs of arbitration proceedings estimated and allocated? The book includes analyses of arbitration related to specific fields of the law, notably sports, administrative, tax, intellectual property rights (especially regarding reference and generic medicines), and corporate disputes. Each chapter provides, for the topics it addresses, an examination of the applicable laws, rules, arbitration practice, and views taken by arbitral tribunals and state courts as well as those of the most highly considered scholars. As a detailed examination of the legal framework and of all procedural steps of an arbitration in Portugal, from the drafting of an arbitration agreement to the enforcement of an award, this book constitutes an invaluable resource for parties involved in or considering an international arbitration in this country. The guidance that it seeks to provide in respect of any problem likely to arise in this context can be useful to arbitrators, judges, academics, and interested lawyers.
Author: Javed Ali
Publisher: Academic Press
ISBN: 0128222239
Category : Medical
Languages : en
Pages : 287
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Book Description
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
Author: Stephen F. Amato
Publisher: Elsevier
ISBN: 0857099205
Category : Technology & Engineering
Languages : en
Pages : 203
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Book Description
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. - Addresses global regulations and regulatory issues surrounding biomaterials and medical devices - Especially useful for smaller companies who may not employ a full time vigilance professional - Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
Author: Pieter Jan Kuijper
Publisher: Kluwer Law International B.V.
ISBN: 9041154124
Category : Law
Languages : en
Pages : 1251
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Book Description
The Law of the European Union is a complete reference work on all aspects of the law of the European Union, including the institutional framework, the Internal Market, Economic and Monetary Union and external policy and action. Completely revised and updated, with many newly written chapters, this fifth edition of the most thorough resource in its field provides the most comprehensive and systematic account available of the law of the European Union (EU). Written by a new team of experts in their respective areas of European law, its coverage incorporates and embraces many current, controversial, and emerging issues and provides detailed attention to historical development and legislative history of EU law. Topics that are constantly debated in European legal analysis and practice are touched on in ways that are both fundamental and enlightening, including the following: .powers and functions of the EU law institutions and relationship among them; .the principles of equality, loyalty, subsidiarity, and proportionality; .free movement of persons, goods, services, and capital; .mechanisms of constitutional change – treaty revisions, accession treaties, withdrawal agreements; .budgetary principles and procedures; .State aid rules; .effect of Union law in national legal systems; .coexistence of EU, European Convention of Human Rights (ECHR), and national fundamental rights law; .migration and asylum law; .liability of Member States for damage suffered by individuals; .competition law – cartels, abuse of dominant position, merger control; .social policy, equal pay, and equal treatment; .environmental policy, consumer protection, public health, cultural policy, education, and tourism; .nature of EU citizenship, its acquisition, and loss; and .law and policy of the EU’s external relations. The fifth edition embraces many new, ongoing, and emerging European legal issues. As in the previous editions, the presentation is notable for its attention to how the law relates to economic and political realities and how the various policy areas interact with each other and with the institutional framework. The many practitioners and scholars who have relied on the predecessors of this definitive work for years will welcome this extensively revised and updated edition. Those coming to the field for the first time will instantly recognize that they are in the presence of a masterwork that can always be turned to with profit and that helps in understanding the rationale underlying any EU law provision or principle.
Author: David Mantus
Publisher: CRC Press
ISBN: 1841849200
Category : Medical
Languages : en
Pages : 401
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Book Description
FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
Author: John Geigert
Publisher: Springer
ISBN: 3030137546
Category : Medical
Languages : en
Pages : 446
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Book Description
Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
Author: Gloria Hall
Publisher:
ISBN: 9781947493032
Category :
Languages : en
Pages :
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Book Description
