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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
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in
Dieser Band gehört zur bekannten Wiley-Reihe 'Current Toxicology Series' und befasst sich ausführlich mit der Pestizidtoxikologie. Untersucht werden Pestizide nach Gruppen (z. B. Insektizide und Fungizide), ihre Rückstände in Lebensmitteln sowie die Metabolisierung von Pestiziden. Darüber hinaus werden berufsbezogene Aspekte und die Behandlung von Vergiftungserscheinungen umfassend diskutiert. "Pesticide Toxicology" ist das erste einbändige Werk zum Thema Pestizide, das spezialisierte und dennoch umfassende Informationen sowohl für Experten als auch für Doktoranden bereit hält. Herausgeber Timothy Marrs ist ein international anerkannter Experte in der Pestizidforschung und genießt großes Ansehen auf dem Gebiet der Toxikologie. Geschrieben wurde der Band von einem Team international renommierterToxikologen.
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.
FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
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.
The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS
How has the regulation of business shifted from national to global institutions? What are the mechanisms of globalization? Who are the key actors? What of democratic sovereignty? In which cases has globalization been successfully resisted? These questions are confronted across an amazing sweep of the critical areas of business regulation--from contract, intellectual property and corporations law, to trade, telecommunications, labor standards, drugs, food, transport and environment. This book examines the role played by global institutions such as the World Trade Organization, World Health Organization, the OECD, IMF, Moodys and the World Bank, as well as various NGOs and significant individuals. Incorporating both history and analysis, Global Business Regulation will become the standard reference for readers in business, law, politics, and international relations.
Regulation of Functional Foods and Nutraceuticals: A Global Perspective offers a comprehensive resource for information on regulatory aspects of the growing and economically important functional food industry. Regulatory systems and definitions of key terms-food, supplement, drug, etc-vary from country to country. A thorough understanding of laws and regulation within and among key countries with regard to functional foods, herbal extracts or drugs, and nutritional supplements is critical to the direction of food companies that are developing products for these markets. International experts with legal and/or scientific expertise address relevant topics from quality issues, to organic foods to labeling. Innovative product development within the framework of existing regulations will be addressed in individual chapters. Overview chapters will discuss global principles, inter-country trading issues, and present a comparison of the laws and regulations within different countries graphically. A "must-have" handbook for research professionals, management, and marketing strategists in the worldwide functional foods/nutritional supplements business. Food technicians and engineers responsible for manufacturing quality in this industry should add it to their library to ensure that they have a thorough knowledge of the applicable legal requirements. The book will also serve as an indispensable shelf reference for lawyers in the food industry and government health professionals with regulatory responsibilities.