Articles on FDA, regulatory policy, compliance, biosimilars/follow-on biologics - BioPharm International

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GMPs & Validation
What you need to know about regulatory compliance, good manufacturing practices (GMPs), and validation, including evolving regulatory policy and developments in biosimilars.

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FDA Seeks Active System for Monitoring Adverse Events
August 1, 2008
A Rational Approach for Setting & Maintaining Specs for Biological & Biotechnology–Derived Products—Part 3
August 1, 2008
GMPs in Phase 1: Take 2
August 1, 2008
Medicare Drug Coverage Under Fire
July 18, 2008
FDA Launches E-Filing Initiative
July 10, 2008
2008 PDA/FDA Joint Regulatory Conference
Sep 8, 2008 - Sep 12, 2008
Washington, DC
Biosimilars Conference
Sep 10, 2008 - Sep 11, 2008
Berlin, Germany
ISPE Conference on Product and Process Quality
Sep 15, 2008 - Sep 18, 2008
Manchester, United Kingdom
bioLOGIC Europe
Sep 16, 2008 - Sep 19, 2008
Geneva, Switzerland
4th Annual Global Pharma Manufacturing Summit
Sep 22, 2008 - Sep 24, 2008
Chicago, IL
Addition Vessels
Bioengineering AG
Cleaning Validation: On-Site Trials of SpotView(R)
September 3, 2008
Fermentation Process Monitoring II: Mammalian Cell Culture
September 3, 2008
Fermentation Process Monitoring: Dissolved Carbon Dioxide
September 3, 2008
Global Biochemical Profiling for Bioprocessing Optimization
August 26, 2008
Final Bulk Inspection of Solid-Dose Pharmaceuticals
August 20, 2008
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