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Author : Gloria Hall
Publisher :
ISBN 13 : 9781947493636
Total Pages : pages
Book Rating : 4.4/5 (936 download)
Download or read book Fundamentals of International Regulatory Affairs, Fifth Edition written by Gloria Hall and published by . This book was released on 2021-06-25 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Salma Michor
Publisher :
ISBN 13 : 9780989802802
Total Pages : pages
Book Rating : 4.8/5 (28 download)
Download or read book Fundamentals of International Regulatory Affairs, Second Edition written by Salma Michor and published by . This book was released on 2013-09-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Reference book of laws, standards and regulations applicable to healthcare product manufacture on the international market.
Author :
Publisher :
ISBN 13 : 9780978700652
Total Pages : 222 pages
Book Rating : 4.7/5 (6 download)
Download or read book Fundamentals of International Regulatory Affairs written by and published by . This book was released on 2010 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 : 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 : Zeeshaan Arshad
Publisher :
ISBN 13 : 9780996949194
Total Pages : 440 pages
Book Rating : 4.9/5 (491 download)
Download or read book Fundamentals of International Regulatory Affairs written by Zeeshaan Arshad and published by . This book was released on 2017 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: Laws and regulations governing healthcare product marketing submissions in multiple geographies.
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 : 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 : 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 :
Publisher :
ISBN 13 :
Total Pages : 540 pages
Book Rating : 4.:/5 (13 download)
Download or read book Fundamentals of US Regulatory Affairs written by and published by . This book was released on 2013 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 : 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 : 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 : 9780967311562
Total Pages : 282 pages
Book Rating : 4.3/5 (115 download)
Download or read book Fundamentals of EU Regulatory Affairs written by and published by . This book was released on 2004 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 : P. Michael Dubinsky
Publisher : John Wiley & Sons
ISBN 13 : 1118949595
Total Pages : 554 pages
Book Rating : 4.1/5 (189 download)
Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
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.
