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Author : Syed Rizwanuddin Ahmad
Publisher :
ISBN 13 : 9780997769777
Total Pages : pages
Book Rating : 4.7/5 (697 download)
Download or read book Fundamentals of US Regulatory Affairs written by Syed Rizwanuddin Ahmad and published by . This book was released on 2017-07 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Peggy Berry
Publisher :
ISBN 13 : 9780978700621
Total Pages : 464 pages
Book Rating : 4.7/5 (6 download)
Download or read book Fundamentals of US Regulatory Affairs, Sixth Edition written by Peggy Berry and published by . This book was released on 2009-08 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 : 9781947493339
Total Pages : 740 pages
Book Rating : 4.4/5 (933 download)
Download or read book Fundamentals of US Regulatory Affairs written by and published by . This book was released on 2019 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Douglas J. Pisano
Publisher : CRC Press
ISBN 13 : 1040061974
Total Pages : 466 pages
Book Rating : 4.0/5 (4 download)
Download or read book FDA Regulatory Affairs written by Douglas J. Pisano and published by CRC Press. This book was released on 2008-08-11 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Author : Javed Ali
Publisher : Academic Press
ISBN 13 : 0128222239
Total Pages : 287 pages
Book Rating : 4.1/5 (282 download)
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
Author : Alix E. Alderman
Publisher :
ISBN 13 : 9780982932063
Total Pages : 552 pages
Book Rating : 4.9/5 (32 download)
Download or read book Fundamentals of US Regulatory Affairs, Eighth Edition written by Alix E. Alderman and published by . This book was released on 2013-06-30 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Gloria Hall
Publisher :
ISBN 13 : 9781947493513
Total Pages : pages
Book Rating : 4.4/5 (935 download)
Download or read book Fundamentals of Pharmaceutical and Biologics Regulations, Third Edition written by Gloria Hall and published by . This book was released on 2020-07-29 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Stephen F. Amato
Publisher : Elsevier
ISBN 13 : 0857099205
Total Pages : 203 pages
Book Rating : 4.8/5 (57 download)
Download or read book Regulatory Affairs for Biomaterials and Medical Devices written by Stephen F. Amato and published by Elsevier. This book was released on 2014-10-27 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : David Mantus
Publisher : CRC Press
ISBN 13 : 1841849200
Total Pages : 401 pages
Book Rating : 4.8/5 (418 download)
Download or read book FDA Regulatory Affairs written by David Mantus and published by CRC Press. This book was released on 2014-02-28 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Jack Wong
Publisher : CRC Press
ISBN 13 : 1000440516
Total Pages : 806 pages
Book Rating : 4.0/5 (4 download)
Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Author : Raps
Publisher :
ISBN 13 : 9780982932100
Total Pages : 372 pages
Book Rating : 4.9/5 (321 download)
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:
Author : Gloria Hall
Publisher :
ISBN 13 : 9781947493490
Total Pages : 726 pages
Book Rating : 4.4/5 (934 download)
Download or read book Fundamentals of Medical Device Regulations, Third Edition written by Gloria Hall and published by . This book was released on 2020-07-29 with total page 726 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fundamentals of Medical Device Regulations is a compilation of history, medical device and in vitro diagnotic (IVD) medical device information from RAPS' regional publications: Fundamentals of US Regulatory Affairs, Eleventh Edition; Fundamentals of Canadian Medical Device Regulations; Fundamentals of EU Regulatory Affairs, Ninth Edition; Fundamentals of International Regulatory Affairs, Fourth Edition."--Foreword.
Author : Cass R. Sunstein
Publisher : Simon and Schuster
ISBN 13 : 1476726612
Total Pages : 272 pages
Book Rating : 4.4/5 (767 download)
Download or read book Simpler written by Cass R. Sunstein and published by Simon and Schuster. This book was released on 2013-04-09 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Simpler government arrived four years ago. It helped put money in your pocket. It saved hours of your time. It improved your children’s diet, lengthened your life span, and benefited businesses large and small. It did so by issuing fewer regulations, by insisting on smarter regulations, and by eliminating or improving old regulations. Cass R. Sunstein, as administrator of the most powerful White House office you’ve never heard of, oversaw it and explains how it works, why government will never be the same again (thank goodness), and what must happen in the future. Cutting-edge research in behavioral economics has influenced business and politics. Long at the forefront of that research, Sunstein, for three years President Obama’s “regulatory czar” heading the White House Office of Information and Regulatory Affairs, oversaw a far-reaching restructuring of America’s regulatory state. In this highly anticipated book, Sunstein pulls back the curtain to show what was done, why Americans are better off as a result, and what the future has in store. The evidence is all around you, and more is coming soon. Simplified mortgages and student loan applications. Scorecards for colleges and universities. Improved labeling of food and energy-efficient appliances and cars. Calories printed on chain restaurant menus. Healthier food in public schools. Backed by historic executive orders ensuring transparency and accountability, simpler government can be found in new initiatives that save money and time, improve health, and lengthen lives. Simpler: The Future of Government will transform what you think government can and should accomplish.
Author : Gloria Hall
Publisher :
ISBN 13 : 9781947493674
Total Pages : pages
Book Rating : 4.4/5 (936 download)
Download or read book Fundamentals of Medical Device Regulations, Fourth Edition written by Gloria Hall and published by . This book was released on 2021-07-23 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : David A. Moss
Publisher : The Tobin Project
ISBN 13 : 0982478801
Total Pages : 169 pages
Book Rating : 4.9/5 (824 download)
Download or read book New Perspectives on Regulation written by David A. Moss and published by The Tobin Project. This book was released on 2009 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: As an experiment in reconnecting academia to the broader democracy, this work is designed to invigorate public policy debate by rededicating academic work to the pursuit of solutions to society's great problems.
Author : Pamela Anne Jones
Publisher :
ISBN 13 : 9781947493179
Total Pages : 502 pages
Book Rating : 4.4/5 (931 download)
Download or read book Fundamentals of International Regulatory Affairs written by Pamela Anne Jones and published by . This book was released on 2018 with total page 502 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Frank Nellen
Publisher : Kluwer Law International B.V.
ISBN 13 : 9403523441
Total Pages : 643 pages
Book Rating : 4.4/5 (35 download)
Download or read book Fundamentals of EU VAT Law written by Frank Nellen and published by Kluwer Law International B.V.. This book was released on 2020-08-19 with total page 643 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
