Needham, MA (PRWEB) February 25, 2009
IND Submissions: A Primer provides a "hands-on" approach that teaches regulatory professionals - novice and veteran alike - to work with the regulations, guidance documents, content templates, contributing authors, and style guides necessary to write an IND. The book's writing tips show regulatory professionals how to produce a range of U.S. drug and biologics submissions that comply with the requirements and are also clear to read. Included with the book is a CD filled with electronic examples.
The 600-page, spiral-bound, hardcover book is easy to use, providing step-by-step instructions on how to plan, write, and submit regulatory documents. Each chapter (62 in total) is divided by easy-to-read tabs.
IND Submissions: A Primer is the ideal resource for new professionals entering the field, a useful training guide, and a valuable reference for the experienced professional. This comprehensive "how-to" guide contains:
- 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 needed in a submission
- Tips and lessons learned from the author's experience
- Different perspectives on how a submission can be approached
- Applicable FDA Form 1571 information for each submission
- Paper publishing tips
- Electronic CTD publishing sections for each submission, where applicable
- Real life examples taken from the press and approved NDAs when available
- Electronic examples and content templates to utilize so that an RA professional can begin immediately working on a submission
IND Submissions: A Primer is available for $295 per copy by calling 800-856-2556, or by ordering online at http://www.barnettinternational.com. Estimated shipping date is February 27, 2009.
About the author:
IND Submissions: A Primer was written by Meredith Brown-Tuttle, RAC, a regulatory consultant whose background incorporates all aspects of drug, device, and biologics development including clinical research, data management, medical writing, and regulatory affairs. 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. Ms. Brown-Tuttle also teaches about regulatory submissions, intelligence, strategy, and agency interactions for the Regulatory Affairs Certificate program at UC Santa Cruz.
About Cambridge Healthtech Institute
Cambridge Healthtech Institute (CHI) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI's portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners and Cambridge Healthtech's Media Group, which includes numerous e-newsletters as well as Bio-IT World magazine.
Founded in 1992, Cambridge Healthtech Institute strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments. Basic research related to commercial implications is covered, with heavy emphasis placed on end-user insights into new products and technology as well as coverage on the strategy behind the business.
About Barnett International
Founded in 1979, Barnett International is widely recognized for its superior consulting services and its targeted education and training programs. Barnett helps clients get the most out of their research and development dollars by managing change effectively, improving organizational performance, and enhancing staff knowledge. The Barnett approach is a unique combination of strategy development and practical, hands-on implementation. The "Barnett Difference" is evident in our deep understanding of the clinical research process and in the rapid and tangible performance improvements we deliver.
We help pharmaceutical, biotechnology and medical device companies maximize the speed and quality of their product development efforts. With an international presence and with many staff members working from the client site for increased benefits, Barnett is able to apply a global expertise to its projects.
Our services include educational programs and products and consulting.
The source of our expertise:
- Exclusively focused on the pharmaceutical/biopharmaceutical industry for more than 20 years
- A team of talented professionals (150+) with deep-rooted industry insight and expertise
- An in-depth understanding of different cultures and unique organizations
- Experience working with major pharmaceutical companies around the world
- Global resources with offices in the US and Europe
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