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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REMs: Battling the Unknowns
October 22, 2009
Why knowing a drug's risk and preparing for a risk evaluation mitigation strategy early on will considerably benefit a drug's development.
Keys to Drug Development in Latin America
October 1, 2009
The region and its regulatory agencies try to keep up with the rapidly growing clinical trials market.
Working Toward a Better Future
October 1, 2009
The EU struggles to get over its regulatory hurdles in an effort to further R&D success.
FDA Promotes Integrity and Compliance
October 1, 2009
Stiffer enforcement of research standards aims to restore the public's confidence in agency actions.
Global Development Challenges Sponsors
September 1, 2009
International health crises expand testing of new vaccines and drug treatments for third-world diseases.

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Regulatory Strategy for Medical Devices
Nov 9, 2009 - Nov 10, 2009
St. Paul, MN

Medical Device Submission & Compliance Strategy for the US Market
Nov 9, 2009 - Nov 10, 2009
Brussels, Belgium

13th Bio/Pharmaceutical and Medical Device Registries and Post-Approval Studies Congress
Sep 21, 2010 - Sep 23, 2010
Philadelphia, PA

Articles By Category
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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Schulman Associates IRB Establishes Itself in Canada
European Medicines Agency Implements Internal Reorganization
Pressure Mounts for ICH GCP Revisions
Business and People Update
BSI Launches New CE-Dedicated FastTrack Program
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