IND Submissions: A Primer
| Author | : | |
| Rating | : | 4.74 (509 Votes) |
| Asin | : | 0578007002 |
| Format Type | : | paperback |
| Number of Pages | : | 530 Pages |
| Publish Date | : | 2017-03-29 |
| Language | : | English |
DESCRIPTION:
Five Stars Dudley Smith Well organized.. A good reference book for regulatory professionals I came across "IND Submission: A Primer" as a text book for a class taught by the author, Meredith Brown-Tuttle. Since taking the class the red book has become my favorite reference book.A Primer is a step by step guide that covers a wide range of topics for IND submissions, starting from style guides, submission planning to publishing. IND submission process starts with a pre IND meeting with the FDA. The writing and compilation of various sections of the IND follows. There is also a section on writing amendments to an IND. Each step includes a list of guidance d. A must have book This book is right for persons at all levels. If you just want to know what regulatory affairs about, you will get the idea easily by scanning through the book; if you want to file a IND, that is fine, this book guides you step by step to do this job. In addition, this books comes will a CD which covers almost every aspect of IND filings for your reference. On the other hand, if you are a veterans in this field, this book is still useful to you, as it not only be a fantastic reference book at your desk, it also include various technical helps for IND filing, inclu
Brown-Tuttle also teaches about regulatory submissions, intelligence, strategy, and agency interactions for the Regulatory Affairs Certificate program at UC Santa Cruz. . Meredith Brown-Tuttle, RAC, is a regulatory consultant whose background incorporates all aspects of drug, device, and biologics development including clinical research, data management, medical writing, and regul
This 600-page, spiral-bound, hardcover book is easy to use, providing step-by-step instructions on how to plan, write, and submit regulatory documents. Specific topics include: * Regulations and guidance document references. Each chapter (62 in total) is divided by easy-to-read tabs. * Where to pull, re-use, or start as a basis for information needed in a submission. * Different perspectives on how a submission can be approached. Included with the book is a CD filled with electronic examples. IND Submissions: A Primer provides a hands-on approach that teaches re
. She served for six years on the Board of Editors for the Regulatory Affairs Professional Society s journal, Focus, and has published numerous articles, edited books and book chapters, and presented at professional meetings on a variety of clinical research and regulatory topics. Brown-Tuttle also teaches about regulatory submissions, intelligence, strategy, and agency interactions for the Regulatory Affairs Certificate program at UC Santa Cruz. About the Author Meredith Brown-Tuttle, RAC, is a regulatory consultant whose background incorporates all aspects of drug, device, and biologics development including clinical research, data management, medical writing, and regulatory affairs. Ms