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John Robinson's Blog – December 2017 Archive (10)

Tougher FDA import rules are aimed at putting strict controls on imports

Tougher FDA import rules are aimed at putting strict controls on imports 3 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/tougher-fda-import-rules-are-aimed-at-putting-strict-controls-on-imports-3.jpg?w=1400 1400w,…

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Added by John Robinson on December 14, 2017 at 4:30am — No Comments

Best Practices in Vendor Risk and Compliance Management



Best Practices in Vendor Risk and Compliance Management.jpg https://globalcompliancepaneltraining.files.wordpress.com/2017/12/best-practices-in-vendor-risk-and-compliance-management.jpg?w=838 838w,…

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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



FDA Requirements for ensuring Premarketing Clinical Trial Safety 2 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/fda-requirements-for-ensuring-premarketing-clinical-trial-safety-2.jpeg?w=844&h=562 844w,…

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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…

The FDA's requirements for non-IND Foreign Clinical Studies 2

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Added by John Robinson on December 11, 2017 at 5:41am — No Comments

The Investigational New Drug Applications mechanism in the USA



The Investigational New Drug Applications mechanism in the USA.jpg https://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-investigational-new-drug-applications-mechanism-in-the-usa.jpg?w=866&h=650 866w,…

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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



Technical Writing for the Pharma, Device and Biotech Industries 3 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/technical-writing-for-the-pharma-device-and-biotech-industries-3.jpg?w=690&h=660 690w,…

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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…

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Added by John Robinson on December 4, 2017 at 4:50am — No Comments

Data Mining and Signal Detection in Pharmacovigilance

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…

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Added by John Robinson on December 1, 2017 at 4:35am — No Comments

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