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IND Submissions: A Primer
Cambridge Healthtech Institute, Feb 2009, Pages: 600
An in-depth guide to writing, editing, tracking, and submitting the original IND and applicable IND amendments
The book provides a “hands-on” approach that will teach Regulatory professionals -- novice and veteran alike -- to work with regulations, guidance documents, content templates, style guides, the necessary information needed to write the document and provide writing tips to produce a range of U.S. drug and biologics submissions that comply with the requirements and are clear to read.
The 600-page, spiral-bound, hardcover book is easy to use that outlines step-by-step on how to plan, write, and submit regulatory documents. Each chapter (62 in total) is divided by easy-to-read tabs and includes a CD filled with electronic examples. It is the ideal resource for new professionals entering the field, a useful training guide, and a valuable reference for the experienced professional.
In this comprehensive 'how-to' guide, the following details are contained:
- Regulations and guidance document references
- Overview and background of why the submission is required
- Structure of the submission itself
- Details on who should contribute to the submission
- Where to pull, re-use or start as a basis for information contained in submission
- Tips and lessons learned from the author''s experience
- Different perspectives on how a submission can be approached
- Paper Publishing Tips
- Applicable FDA Form 1571 information for each submission
- Where applicable, the sections of the electronic CTD section items will be slotted
- Real life examples taken from the press and approved NDAs when available
- Electronic examples and content templates to utilize so that an RA professionals can begin immediately working on the submission
* To view the detailed table of contents, please see the link below*
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