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Added by John Robinson on December 13, 2017 at 4:45am —
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Added by John Robinson on December 12, 2017 at 5:08am —
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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…
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Added by John Robinson on December 11, 2017 at 5:41am —
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Added by John Robinson on December 8, 2017 at 5:40am —
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Added by John Robinson on December 7, 2017 at 6:45am —
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Added by John Robinson on December 6, 2017 at 5:53am —
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Added by John Robinson on December 5, 2017 at 6:08am —
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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…
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Added by John Robinson on December 4, 2017 at 4:50am —
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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…
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Added by John Robinson on December 1, 2017 at 4:35am —
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There are various core components of a financial audit program. First, an understanding of a financial audit:
- A financial audit is a regular exercise carried out by qualified professionals from within or outside, to check the financial health of an organization
- It involves having to verify, examine and analyze the various data…
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Added by John Robinson on November 30, 2017 at 5:37am —
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Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.
Logistics and supply chain management is emerging as a…
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Added by John Robinson on November 29, 2017 at 4:53am —
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The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action.
The adverse event reporting system may be understood as being a database…
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Added by John Robinson on November 28, 2017 at 5:43am —
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The internal audit checklist for HIPAA is one of the primary elements of HIPAA implementation. The passage of the Health Insurance Portability and Accountability Act (HIPAA) by the U.S. Congress in 1996 was aimed at regulating the way and process by which healthcare institutions across the country reveal the medical information of their patients.
The Department of…
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Added by John Robinson on November 24, 2017 at 4:45am —
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The most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark.
In a very broad sense, the potential areas of risk management include all areas of a business, because simply…
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Added by John Robinson on November 23, 2017 at 4:41am —
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With over four million employed directly or in allied sectors and catering to the world’s largest market and research area, biotech and pharma is a fast growing industry. Its courses are designed to prepare individuals for this giant industry.
Biotech and pharmaceutical courses are much sought after by aspiring…
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Added by John Robinson on November 22, 2017 at 5:09am —
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Auditing Quality Management Systems is a core requirement for ensuring that Quality Management Systems – defined as “…a set of policies, processes and procedures required for planning and execution” in the core business area of an organization, meaning those that impact the ability of the organization to meet…
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Added by John Robinson on November 21, 2017 at 5:20am —
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Good Manufacturing Practices (GMPs) constitute one of the core components that go into the manufacture and distribution of foods, drugs and other pharmaceutical products. Good Manufacturing Practices are prescribed by regulatory agencies from around the world, the FDA and the EMA being among them.
The guidelines set out by these regulatory…
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Added by John Robinson on November 20, 2017 at 5:22am —
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Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and…
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Added by John Robinson on November 17, 2017 at 5:22am —
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Forward, the San Francisco-based startup that’s looking to refashion healthcare services in Apple’s image, is…
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Added by John Robinson on November 16, 2017 at 5:07am —
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Business News | 20 hours ago | Erica Apodaca
Arizona has a serious doctor shortage. The state is a “Designated Health Professional Shortage Area” and according to the latest numbers from the Health Resources &…
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Added by John Robinson on November 15, 2017 at 5:20am —
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