Industry guidances and drafts by organizations like FDA, ICH, EMEA, USP & IPEC. Harmonization. Government policy. Validation, inspection, CGMP, imports & safety. Quality by Design (QbD), process analytical technology.
March 11, 2010
ePT--the Electronic Newsletter of Pharmaceutical Technology
FDA Published The International Conference on Harmonization S9 Guideline; ISPE Released A New Good Practice Guide On Manufacturing Execution Systems.
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March 11, 2010
By:Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology
The World Health Organization released new guidelines this week for the treatment of malaria and the first-ever guidelines on procuring safe and efficacious antimalarial drugs.
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March 11, 2010
ePT--the Electronic Newsletter of Pharmaceutical Technology
Exelixis And XenoPort Announce Job Cuts; GSK Dedicates India Facility; And More.
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March 11, 2010
By:Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology
The Pharmaceutical Research and Manufacturers of America, along with eight other pharmaceutical, business, and trade organizations, are calling on Russian authorities to consider policy changes concerning clinical-trial regulation and intellectual property.
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March 11, 2010
By:Erik Greb
ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.
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March 9, 2010
By:Timothy Lozier
In this paper, we will examine a real-world example of how using a risk assessment model in a quality management system can identify critical adverse events, mitigate the risk, and prevent re-occurrence of these events.
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March 4, 2010
By:Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration and the European Medicines Agency are implementing a streamlined process to help regulators better identify and share information regarding orphan-drug and biologic products.
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March 4, 2010
ePT--the Electronic Newsletter of Pharmaceutical Technology
Astellas Pharma Makes Bid for OSI Pharmaceuticals; Ringo Retiring From Pfizer; And More.
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March 4, 2010
By:Erik Greb
ePT--the Electronic Newsletter of Pharmaceutical Technology
Last week, the US Food and Drug Administration and the National Institutes of Health unveiled plans to establish a Joint Leadership Council to address important public-health issues.
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