Items related to Preparation and Maintenance of the IND Application...
Synopsis
Whether you're still filing IND submissions in paper, or have filed electronically for a while, you'll value this just-published book from FDAnews. Author William Sietsema, drawing on his real-world experience with IND submissions - and adding real-world case studies from ZymoGenetics and Epix - offers ready-to-use, expert guidance on the content and structure of all the components of an IND in CTD format with the focus on electronic submissions. Order now for full life-cycle guidance on managing your IND submission, including: · Best practices for converting paper INDs into compliant eCTD submissions · The Structure of eCTD IND applications · How to evaluate an eCTD system · How to manage the life-cycle of eCTD INDs · Specific content and technical requirements of an IND in eCTD Format · How to transition an eCTD IND into an eCTD new drug application · How to avoid common (but costly!) errors with electronic submissions · Secrets for creating an effective eCTD culture · Choosing and using eCTD tools You'll discover exactly what's required at every point in the IND lifecycle to properly submit your IND in eCTD format, avoid resubmissions and accelerate your time to market. And while other companies are struggling to make the transition, you'll already have your systems in place.
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- PublisherFDAnews
- Publication date2008
- ISBN 10 1600040063
- ISBN 13 9781600040061
- BindingPaperback
- LanguageEnglish
- Number of pages256
- EditorWilliam K. Sietsema
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