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Medical Device Development: Regulation and Law |
Sep 2009 |
$195.00 |
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Medical Device Development: Regulation and Law, 2009 Edition, is the ''must-have'' resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical
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Published by: Barnett Educational Services
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2
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PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2009/2010 |
Jun 2009 |
$425.00 |
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PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2009/2010 is the leading resource for statistics, trends, and proprietary market intelligence and analysis on the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analysis, the Sourcebook provides
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Published by: Barnett Educational Services
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3
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Good Clinical Practice: A Question & Answer Reference Guide 2009 |
May 2009 |
$45.00 |
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Expanded and Updated for 2009!
For CRAs, investigators/sites, auditors, compliance, legal, and other clinical professionals...
"This book should be mandatory reading for every person involved in clinical research."
Munish Mehra, Ph.D., Managing Director,
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Published by: Barnett Educational Services
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4
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IND Submissions: A Primer |
Mar 2009 |
$295.00 |
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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
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Published by: Barnett Educational Services
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5
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Glossary Acronyms for Clinical Research Professionals |
Feb 2009 |
$19.95 |
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Recently updated in 2009 due to popular demand!
Do you ever wish you had the quickly-evolving terminology of our industry at your fingertips? This easy to use "back-pocket" reference guide helps you to navigate
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Published by: Barnett Educational Services
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6
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The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors |
Oct 2008 |
$45.00 |
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The 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors...Shipping in October, 2008!
This year alone, well over 20,000 clinical investigators from around the globe will complete the mandatory Form FDA 1572-Statement of
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Published by: Barnett Educational Services
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7
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The US Drug Approval Trends and Yearbook 2008/2009 |
Jul 2008 |
$295.00 |
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Finally a comprehensive source for the very latest performance metrics and trend analysis on every key aspect of the new drug approval process--The US Drug Approval Trends and Yearbook 2008/2009!
Building on last year's
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Published by: Barnett Educational Services
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8
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U.S. Regulatory Reporter |
Jul 2008 |
$395.00 |
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This publication, the U.S. Regulatory Reporter Newsletter, is a monthly newsletter providing regulatory information for the pharmaceutical, medical and allied industries, and has been the primary source of FDA news for hundreds of regulatory and
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Published by: Barnett Educational Services
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9
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PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2008/2009 |
Jun 2008 |
$425.00 |
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PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2008/2009 is packed with more cutting-edge and proprietary intelligence and analyses not available anywhere else--for example:
New proprietary analyses on US clinical trial starts, now segmented for the first
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Published by: Barnett Educational Services
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10
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New Drug Development: A Regulatory Overview (8th Edition) |
Jan 2008 |
$145.00 |
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Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments
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Published by: Barnett Educational Services
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11
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State-by-State Clinical Trial Requirements Reference Guide 2007 |
Sep 2006 |
$49.95 |
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Today's US-based clinical trials must meet not just federal requirements, but an increasingly complex array of state-specific requirements as well. In fact, many areas critical to clinical studies--age of consent, drug dispensing, genetic testing, and
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Published by: Barnett Educational Services
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12
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Expediting Drug and Biologics Development: A Strategic Approach 2006 |
Feb 2006 |
$145.00 |
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Using a unique "reverse-engineering" approach, dozens of leading experts with extensive experience in all disciplines of drug and biologic development show how careful planning and a sharp focus on the end-goals can be used to
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Published by: Barnett Educational Services
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13
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Biologics Development: A Regulatory Overview 3rd Edition |
Mar 2004 |
$145.00 |
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Biologics Development: A Regulatory Overview 3rd Edition (2004) is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era! Completely revised and updated to address the transfer of therapeutic biological products to
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Published by: Barnett Educational Services
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14
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Part 11 and Drug Development: A Q&A Reference Guide |
Mar 2004 |
$24.95 |
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Part 11 requirements have now taken their place alongside longstanding regulations such as GCP and GLP as standards critical to those developing new drugs. As computer technology, the Internet, email, and other technological advances have
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Published by: Barnett Educational Services
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15
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HIPAA and Human Subjects Research: A Question & Answer Reference Guide |
Mar 2003 |
$24.95 |
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(March 2003)This publication, HIPAA and Human Subjects Research: A Question & Answer Reference Guide (March 2003), by Mark Barnes and Jennifer Kulynych of Ropes & Gray, quickly and conveniently access all of the essential clinical
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Published by: Barnett Educational Services
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16
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Medical Device Development: A Regulatory Overview |
Mar 2000 |
$145.00 |
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Now there is a practical reference guide to help you succeed in the new era of device regulation — Medical Devices Deployment: A Regulatory Overview is the most comprehensive and up-to-date reference for today's medical
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Published by: Barnett Educational Services
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17
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Partnerships in Clinical Trials: Pharmaceutical and Managed Care Alliances |
Feb 1998 |
$135.00 |
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As the competitive landscape shifts, pharmaceutical companies have most recently turned to managed care organizations (MCOs) as a partner in conducting clinical trials. Partnering with MCOs provides pharmaceutical companies with the opportunity to focus on
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Published by: Barnett Educational Services
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18
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Global Biotechnology Product Registration: E.U., U.S., and Japan |
Mar 1997 |
$245.00 |
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Like major pharmaceutical firms, today's biotechnology companies must leverage their development programs internationally and penetrate global markets to remain competitive. To maximize market penetration, most biologics developers are targeting the largest international markets for new
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Published by: Barnett Educational Services
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19
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The Global GCP Compliance Report 2006: US, EU, and Japan |
periodical |
$95.00 |
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As clinical trials are becoming more global in nature and standards for clinical trial conduct are becoming more harmonized, this just-released report presents a first-of-its kind, systematic study of GCP compliance in the world's major
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Published by: Barnett Educational Services
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