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Author : Sven Harmsen
Publisher :
ISBN 13 :
Total Pages : 809 pages
Book Rating : 4.:/5 (221 download)
Download or read book Guide to Drug Regulatory Affairs written by Sven Harmsen and published by . This book was released on 2009 with total page 809 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 : Brigitte Friese
Publisher :
ISBN 13 : 9783871933530
Total Pages : 809 pages
Book Rating : 4.9/5 (335 download)
Download or read book Guide to Drug Regulatory Affairs written by Brigitte Friese and published by . This book was released on 2009 with total page 809 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Brigitte Friese
Publisher :
ISBN 13 : 9783871933240
Total Pages : 1103 pages
Book Rating : 4.9/5 (332 download)
Download or read book Guide to Drug Regulatory Affairs written by Brigitte Friese and published by . This book was released on 2007-01 with total page 1103 pages. Available in PDF, EPUB and Kindle. Book excerpt: Z.T. basierend auf dem "Handbuch der EU-Zulassung". Buch und Online-Version (Firmenlizenz auf Anfrage).
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 : Sandy Weinberg
Publisher : John Wiley & Sons
ISBN 13 : 0470456175
Total Pages : 392 pages
Book Rating : 4.4/5 (74 download)
Download or read book Guidebook for Drug Regulatory Submissions written by Sandy Weinberg and published by John Wiley & Sons. This book was released on 2009-02-23 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: Destined to become every regulatory director's essential desktop companion Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including: Meeting Requests Orphan Drug Applications Investigatory New Drug Applications (INDAs) New Drug Applications (NDAs) 505(b)2 NDAs Abbreviated New Drug Applications (ANDAs) Annual Report This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.
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 : Patrick M. Malone
Publisher : McGraw Hill Professional
ISBN 13 : 0071492038
Total Pages : 907 pages
Book Rating : 4.0/5 (714 download)
Download or read book Drug Information written by Patrick M. Malone and published by McGraw Hill Professional. This book was released on 2010-05-12 with total page 907 pages. Available in PDF, EPUB and Kindle. Book excerpt: Extensive coverage of the Internet as a source of and distribution means for drug information, and detailed sections on evaluating medical literature from clinical trials Audience includes Pharmacists, Pharmacy students and Pharmacy schools Updated to include using PDAs for medication information Covers the ethical and legal aspects of drug information management Nothing else like it on the market
Author : John J. Tobin
Publisher : John Wiley & Sons
ISBN 13 : 3527333266
Total Pages : 341 pages
Book Rating : 4.5/5 (273 download)
Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2023-12-04 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.
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 : Bert Spilker
Publisher : Lippincott Williams & Wilkins
ISBN 13 : 9780781774246
Total Pages : 1277 pages
Book Rating : 4.7/5 (742 download)
Download or read book Guide to Drug Development written by Bert Spilker and published by Lippincott Williams & Wilkins. This book was released on 2009 with total page 1277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by one of the foremost authorities on clinical trials, drug development, and regulatory affairs, Guide to Drug Development is a comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products. The book covers many topics not discussed in any other textbook and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards. Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development. Spilker's Guide to Drug Development will be the standard reference text for everyone working on or studying drug discovery or development, in industry, academia, hospitals, government, and independent laboratories.
Author : C. F. Harrison
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781537090740
Total Pages : 66 pages
Book Rating : 4.0/5 (97 download)
Download or read book Pharmaceutical Regulatory Affairs written by C. F. Harrison and published by Createspace Independent Publishing Platform. This book was released on 2016-08-19 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory affairs. If you're finishing your academic career and are looking for a job in biotech or pharmaceuticals, you will have seen a thousand advertisements for regulatory affairs managers. But...what exactly is regulatory affairs? What would I be doing? What sort of skills do I need? What do I need to know before I start? This book answers all these questions and more, providing an introduction to the complex world of regulatory affairs. We cover typical tasks; required skills; the ins and outs of the submission process; vital knowledge you'll need to have; and much more. Lost in a sea of acronyms? We've got you covered. Not really sure how regulatory fits into pharmaceutical development? We explain the process. No idea why your new boss keeps going on about module 3.2.P.7? No problem. Whether you're looking for a job, preparing for an interview, or have just started in the field, this book will give you the foundational knowledge you need to succeed.
Author : John J. Tobin
Publisher : John Wiley & Sons
ISBN 13 : 3527644717
Total Pages : 304 pages
Book Rating : 4.5/5 (276 download)
Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. 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. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Author : Vandana B. Patravale
Publisher : CRC Press
ISBN 13 : 1498730787
Total Pages : 438 pages
Book Rating : 4.4/5 (987 download)
Download or read book Pharmaceutical Product Development written by Vandana B. Patravale and published by CRC Press. This book was released on 2016-05-25 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive
Author : Helene I. Dumitriu
Publisher : CRC Press
ISBN 13 : 9781574910513
Total Pages : 440 pages
Book Rating : 4.9/5 (15 download)
Download or read book Good Drug Regulatory Practices written by Helene I. Dumitriu and published by CRC Press. This book was released on 1997-09-30 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Drug Regulatory Practices offers a series of policies and procedures to assure quality and timely regulatory submissions to national regulatory agencies. This book begins with introductory chapters describing the need for policy documentation, and the philosophy underlying the policies, and presents policies and standards that can be used as presented or adapted to individual situations in your company.
Author : Dr. S. Valarmathi, Dr. Anasuya Patil, Dr. Abhishek Suman, Mr Vinay Kumar Yanmandru, Dr. NARLA SUNITHA, Prof. (Dr.) Varsha Deva
Publisher : Shashwat Publication
ISBN 13 : 8119281241
Total Pages : 452 pages
Book Rating : 4.1/5 (192 download)
Download or read book TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS written by Dr. S. Valarmathi, Dr. Anasuya Patil, Dr. Abhishek Suman, Mr Vinay Kumar Yanmandru, Dr. NARLA SUNITHA, Prof. (Dr.) Varsha Deva and published by Shashwat Publication. This book was released on 2023-08-04 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book structured in TWO different parts. These parts are as follows: Part I emphasizes on GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), USFDA-NDA/ANDA (U S Food and Drug Administrations- New Drug Approval/Abbreviated New Drug Approval) and TQM (Total Quality Management). GCP (Good Clinical Practices) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates. GLP (Good Laboratory Practices) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data. Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory. GMP (Good Manufacturing Practices) Manufacturing relies on the ability to reproduce exactly a single product hundreds, if not thousands, of times. To make this possible, guidelines have been drawn up in most countries that are similar to the FDA ones described here that define GMPs. Diagnostic companies, including those manufacturing and distributing biosensors, cannot sell their products for either public or professional use unless they have been approved on the basis of these guidelines. USFDA-NDA/ANDA (U S Food and Drug Ad
Author : David Mantus
Publisher : CRC Press
ISBN 13 : 1841849197
Total Pages : 402 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 402 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.
