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John Robinson's Blog – December 2017 Archive (10)
Tougher FDA import rules are aimed at putting strict controls on imports
Added by John Robinson on December 14, 2017 at 4:30am — No Comments
Best Practices in Vendor Risk and Compliance Management
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Added by John Robinson on December 13, 2017 at 4:45am — No Comments
FDA Requirements for ensuring Premarketing Clinical Trial Safety
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Added by John Robinson on December 12, 2017 at 5:08am — No Comments
The FDA's requirements for non-IND Foreign Clinical Studies
The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products…
Added by John Robinson on December 11, 2017 at 5:41am — No Comments
The Investigational New Drug Applications mechanism in the USA
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Added by John Robinson on December 8, 2017 at 5:40am — No Comments
The increasing role of the social media in healthcare
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Added by John Robinson on December 7, 2017 at 6:45am — No Comments
Technical Writing for the Pharma, Device and Biotech Industries
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Added by John Robinson on December 6, 2017 at 5:53am — No Comments
Quality Risk Management in the FDA-Regulated Industry
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Added by John Robinson on December 5, 2017 at 6:08am — No Comments
Export, Import and Trade Compliance Principle – an understanding
Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an…
Added by John Robinson on December 4, 2017 at 4:50am — No Comments
Data Mining and Signal Detection in Pharmacovigilance
A signal is described by the World Health Organization as any information that is reported on a possible or potential causal relationship between a drug and the adverse event it spawns. This relationship can be of virtually any nature, so long as it concerns the drug and the…
Added by John Robinson on December 1, 2017 at 4:35am — No Comments
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