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Author : Gloria Hall
Publisher :
ISBN 13 : 9781947493124
Total Pages : pages
Book Rating : 4.4/5 (931 download)
Download or read book Fundamentals of EU Pharmaceutical and Biologics Regulations written by Gloria Hall and published by . This book was released on 2018-04-23 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 : 9780989802888
Total Pages : pages
Book Rating : 4.8/5 (28 download)
Download or read book Global Pharmaceutical and Biologics Regulation written by and published by . This book was released on 2014-05-23 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Compilation of pharmaceutical and biologics chapters from Fundamentals of EU Regulatory Affairs Sixth Edition, Fundamentals of Canadian Regulatory Affairs Fourth Edition and Fundamentals of Japanese Regulatory Affairs First Edition.
Author : Zeeshaan Arshad
Publisher :
ISBN 13 : 9780997769739
Total Pages : 252 pages
Book Rating : 4.7/5 (697 download)
Download or read book Fundamentals of International Pharmaceutical and Biologics Regulations written by Zeeshaan Arshad and published by . This book was released on 2017 with total page 252 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 : Gloria Hall
Publisher :
ISBN 13 : 9781947493216
Total Pages : pages
Book Rating : 4.4/5 (932 download)
Download or read book Fundamentals of International Pharmaceutical and Biologics Regulations written by Gloria Hall and published by . This book was released on 2018-09-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Regulatory Affairs Professionals Society
Publisher :
ISBN 13 : 9781947493865
Total Pages : 0 pages
Book Rating : 4.4/5 (938 download)
Download or read book Fundamentals of Pharmaceutical and Biologics Regulations: a Global Perspective written by Regulatory Affairs Professionals Society and published by . This book was released on 2023-05 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Pamela A. Jones
Publisher :
ISBN 13 : 9781947493315
Total Pages : pages
Book Rating : 4.4/5 (933 download)
Download or read book Fundamentals of Pharmaceutical and Biologics Regulations written by Pamela A. Jones and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Gloria Hall
Publisher :
ISBN 13 : 9781947493698
Total Pages : pages
Book Rating : 4.4/5 (936 download)
Download or read book Fundamentals of Pharmaceutical and Biologics 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 : Syed Rizwanuddin Ahmad
Publisher :
ISBN 13 : 9781947493018
Total Pages : pages
Book Rating : 4.4/5 (93 download)
Download or read book Fundamentals of US Pharmaceutical and Biologics Regulations written by Syed Rizwanuddin Ahmad and published by . This book was released on 2017-08 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Laws and regulations governing pharmaceutical and biologics products manufacture and marketing in the US.
Author :
Publisher :
ISBN 13 : 9780989802864
Total Pages : pages
Book Rating : 4.8/5 (28 download)
Download or read book Global Pharmaceutical and Biologics Regulation written by and published by . This book was released on 2014-05-23 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Compilation of the pharmaceutical and biologics chapters from Fundamentals of US Regulatory Affairs Eighth Edition and Fundamentals of International Regulatory Affairs Second Edition,
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 : 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 : 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 : 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 : Sally Shorthose
Publisher :
ISBN 13 : 9789041128454
Total Pages : 672 pages
Book Rating : 4.1/5 (284 download)
Download or read book Guide to EU Pharmaceutical Regulatory Law written by Sally Shorthose and published by . This book was released on 2010 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: This online version of this title will be shortly available atwww.kluwerlawonline.com.legislation, cases and customs which apply to the introduction, marketing andsale of a medicinal product (or a medical device) in Europe and to providesome clarity around the aforementioned complicated systems. It iswritten by and for lawyers, both in-house and in private practice, who findthemselves having to advise a client or clients on this ever-changing area oflaw, perhaps on the steps needed to bring a product to market including anysupplementary obligations (such as the need to conduct a clinical trial of theproduct for paediatric use), or perhaps when advising on clinical trialagreements, what “normal” rights and obligations of parties shouldbe included in the agreement. We hope the book will also be of interest andassistance to regulatory advisers. Each chapter presents a particularprocess or subject from a Europe-wide perspective. The chapters take thereader through the life of a medicinal product or medical device, fromdevelopment to clinical trials to product launch and afterwards, and weprovide guidance in matters where regulatory law is used as an instrument oflife-cycle management. With the exception of the advertising chapter,this book deals primarily with the European level of legislation. Where thereare significant national deviations or differences in interpretation, we havebeen able to take advantage of the breadth of Bird & Bird experience in anumber of major jurisdictions: ;UK, ;France, ;Germany, ;Spain, ;Belgium, ;TheNetherlands, ;Italy and ;Sweden tocreate national variations charts that appear at the end of certainchapters. These charts provide information on how the subject matter of thechapter is implemented in those eight major Member States, and they also serveto illustrate how implementation of the EU regulations varies between MemberStates. We have only included relevant or significant information so thelength of these appendices varies, and for some subjects, such as paediatrics,the legislation is so new and pan-European that we decided that no localvariation needed to be included. In addition, at the end of eachchapter we have included a list of guidelines/publications which will directthe readers to sources of additional information. European legislation ispeppered with acronyms. For help keeping them all straight, we included a listof the most commonly used ones in the pharmaceutical area, in addition tothose that appear in each chapter. This online version of this title will be shortly available atwww.kluwerlawonline.com.
Author : John Geigert
Publisher : Springer
ISBN 13 : 3030137546
Total Pages : 426 pages
Book Rating : 4.0/5 (31 download)
Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer. This book was released on 2019-05-08 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Joanne S. Hawana
Publisher :
ISBN 13 :
Total Pages : 185 pages
Book Rating : 4.:/5 (112 download)
Download or read book Promotion of FDA-regulated Medical Products written by Joanne S. Hawana and published by . This book was released on 2018 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promotion of FDA-Regulated Medical Products is the update of the 2013 publication, FDA requirements for prescription drug promotion, by John Driscoll.
