Regulatory - Applied Clinical Trials

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News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry.
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In Vitro to the Rescue
June 1, 2008
Chris Bode, PhD, vice president of corporate development for Absorption Systems, explains the impact of in vitro models relative to the Critical Path Initiative.
EU Imbalances in Risks and Benefits
June 1, 2008
In the European Union, regulators are agonizing over more than just clinical trials.
Health Reformers Seek Effectiveness Data
June 1, 2008
Comparative drug analysis aims to address costs and value as candidates eye curbs on drug spending.
Nigeria's Clinical Trial Scene
June 1, 2008
Low costs, a rich patient base, and strong talent pool characterize Africa's most populated country.
Emerging Market Trends from Europe
June 1, 2008
Survey uncovers current market and future directions for the European clinical trials industry.

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CfPIE's Current Good Laboratory Practices & Current Good Manufacturing Practices—A Basic Primer
Jul 7, 2008 - Jul 9, 2008
Malvern, PA
CfPIE's Reporting Failure Investigations and Process Deviations
Jul 7, 2008 - Jul 9, 2008
Costa Mesa, CA
CfPIE's Overview of FDA Regulatory Compliance For Medical Devices
Jul 10, 2008 - Jul 11, 2008
Costa Mesa, CA
CfPIE's How to Develop an Effective Complaint Handling and Post Market Surveillance Program for Drugs and Devices
Jul 14, 2008 - Jul 15, 2008
Costa Mesa, CA
CfPIE's FDA Inspections of Clinical Data Systems
Jul 17, 2008 - Jul 18, 2008
Costa Mesa, CA
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US
FDA-specific news, columns, and articles.
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EU
Latest news, columns, and articles about EMEA.
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Other Regions
Regulatory updates from worldwide regions
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Octagon Technology platform connects datacollection to submission
Phase Forward Introduces Empirica Signal
The CDISC European Interchange: Upsurge in Standards Implementation and Participation (PDF)
Give Your Input on Impact of EU Clinical Trials Directive
ClinPhone Completes MHRA Inspection
Better Feasibility for Global Clinical Trials
August 8, 2007
Clinical Trials in Russia 1
June 13, 2007
Clinical Trials in Russia 2
June 12, 2007
Costing Methods for Clinical Trials: A Comparison of Activity Based Costing and Traditional Costing
May 31, 2007
7 Total Cost of Ownership Truths to Consider When Deploying an Enterprise Compliance Management System
May 31, 2007
Sage Products voluntary recalls limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product
Novartis changes sections of Myfortic prescribing information
Drugs@FDA Downloadable Data Files (updated)
Public Health Emergency Home Preparation Instructions for Doxycycline
Warning Letter: Travanti Pharma, Inc.
National Drug Code Directory
Last updated on Thu Jul 03 14:05:00 EDT 2008
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