Medical product regulatory affairs: pharmaceuticals, diagnostics, medical devices
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Weinheim
Wiley-Blackwell
©2008
|
| Schlagworte: | |
| Online-Zugang: | DE-861 DE-91 DE-473 Volltext |
| Beschreibung: | Includes bibliographical references and index "This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing."--Microbiology Today, May 2009. Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and 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 include CDER, CBER and |
| Beschreibung: | 1 Online-Ressource (xiii, 283 S.) |
| ISBN: | 9783527623037 3527623035 9783527623044 3527623043 1281947105 9781281947109 |
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Datensatz im Suchindex
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| discipline | Rechtswissenschaft Medizin |
| format | Electronic eBook |
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| spelling | Tobin, John J. Verfasser (DE-588)135917131 aut Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices by John J. Tobin and Gary Walsh Weinheim Wiley-Blackwell ©2008 1 Online-Ressource (xiii, 283 S.) txt rdacontent c rdamedia cr rdacarrier Includes bibliographical references and index "This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing."--Microbiology Today, May 2009. Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and 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 include CDER, CBER and Europäische Union (DE-588)5098525-5 gnd rswk-swf Legislation, Drug / Europe Legislation, Drug / United States Device Approval / Europe Device Approval / United States Equipment and Supplies / Europe Equipment and Supplies / United States Legislation, Pharmacy / Europe Legislation, Pharmacy / United States LAW / Medical Law & Legislation bisacsh Drugs / Law and legislation fast Medical instruments and apparatus / Law and legislation fast Pharmacy / Law and legislation fast Recht Drugs / Law and legislation Pharmacy / Law and legislation Medical instruments and apparatus / Law and legislation Arzneimittelrecht (DE-588)4003139-1 gnd rswk-swf Europa USA USA (DE-588)4078704-7 gnd rswk-swf Europäische Union (DE-588)5098525-5 b Arzneimittelrecht (DE-588)4003139-1 s USA (DE-588)4078704-7 g 1\p DE-604 Walsh, Gary Verfasser (DE-588)13591714X aut Erscheint auch als Druck-Ausgabe, Hardcover 3-527-31877-1 https://onlinelibrary.wiley.com/doi/book/10.1002/9783527623037 Verlag URL des Erstveröffentlichers Volltext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Tobin, John J. Walsh, Gary Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices Europäische Union (DE-588)5098525-5 gnd Legislation, Drug / Europe Legislation, Drug / United States Device Approval / Europe Device Approval / United States Equipment and Supplies / Europe Equipment and Supplies / United States Legislation, Pharmacy / Europe Legislation, Pharmacy / United States LAW / Medical Law & Legislation bisacsh Drugs / Law and legislation fast Medical instruments and apparatus / Law and legislation fast Pharmacy / Law and legislation fast Recht Drugs / Law and legislation Pharmacy / Law and legislation Medical instruments and apparatus / Law and legislation Arzneimittelrecht (DE-588)4003139-1 gnd |
| subject_GND | (DE-588)5098525-5 (DE-588)4003139-1 (DE-588)4078704-7 |
| title | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices |
| title_auth | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices |
| title_exact_search | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices |
| title_full | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices by John J. Tobin and Gary Walsh |
| title_fullStr | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices by John J. Tobin and Gary Walsh |
| title_full_unstemmed | Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices by John J. Tobin and Gary Walsh |
| title_short | Medical product regulatory affairs |
| title_sort | medical product regulatory affairs pharmaceuticals diagnostics medical devices |
| title_sub | pharmaceuticals, diagnostics, medical devices |
| topic | Europäische Union (DE-588)5098525-5 gnd Legislation, Drug / Europe Legislation, Drug / United States Device Approval / Europe Device Approval / United States Equipment and Supplies / Europe Equipment and Supplies / United States Legislation, Pharmacy / Europe Legislation, Pharmacy / United States LAW / Medical Law & Legislation bisacsh Drugs / Law and legislation fast Medical instruments and apparatus / Law and legislation fast Pharmacy / Law and legislation fast Recht Drugs / Law and legislation Pharmacy / Law and legislation Medical instruments and apparatus / Law and legislation Arzneimittelrecht (DE-588)4003139-1 gnd |
| topic_facet | Europäische Union Legislation, Drug / Europe Legislation, Drug / United States Device Approval / Europe Device Approval / United States Equipment and Supplies / Europe Equipment and Supplies / United States Legislation, Pharmacy / Europe Legislation, Pharmacy / United States LAW / Medical Law & Legislation Drugs / Law and legislation Medical instruments and apparatus / Law and legislation Pharmacy / Law and legislation Recht Arzneimittelrecht Europa USA |
| url | https://onlinelibrary.wiley.com/doi/book/10.1002/9783527623037 |
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