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: | FRO01 TUM01 UBG01 URL des Erstveröffentlichers |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| 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 |