Regulatory - Applied Clinical Trials

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Regulatory Zone
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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Conducting Trials in Croatia
November 1, 2009
As a part of Europe, but not the European Union, trials in Croatia can encounter special challenges
Safety Requirements Slow New Drug Approvals
November 1, 2009
FDA reviewers strive to assess new postmarketing programs while also evaluating applications.
Great Expectations: CROs Face Change in Italy
November 1, 2009
How Italy's new quality-driven regulations will ask more of CROs conducting activities in the country.
Health Issues Raise EU's Regulatory Profile
November 1, 2009
Health concerns require EU regulators to become more involved in the politics of health care.
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.

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How to Audit Regulatory Affairs and Clinical Trials
Dec 11, 2009
London, UK
Latin America - Understanding Regulatory Compliance Requirements
Jan 11, 2010 - Jan 12, 2010
Costa Mesa, CA
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
Jan 13, 2010 - Jan 14, 2010
Costa Mesa, CA USA
FDA Inspections of Clinical Data Systems
Feb 8, 2010 - Feb 9, 2010
Malvern, PA USA
Overview of FDA Regulatory Compliance for Medical Devices
Mar 22, 2010 - Mar 23, 2010
Dublin, Ireland
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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Business and People Update
Schulman Associates IRB Establishes Itself in Canada
European Medicines Agency Implements Internal Reorganization
Pressure Mounts for ICH GCP Revisions
Business and People Update
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