All Blog Posts Tagged 'in' (71)

After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.

The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement…

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Japan is the world's third largest market for medical devices, after the US and Europe. Ironically, many of the world's medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are…

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Nanotechnology, a part of Quantum Physics (QP), is growing fast and has myriad uses. Nanotechnology is all about size and self-assembly. While QP deals with subatomic particles and waves; Nano relates to the atomic and molecular level. Atomic behavior and properties get dramatically changed at the Nano level. Of note are properties such as color change due to refraction of light. Gold, packaging and chemistry are some of the well-known areas into which…

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It is important to ensure food safety in hospitals

Hospitals being what they are – where patients of almost all kinds visit or stay – are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination…

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Workplace Safety Regulations :

Workplace safety is a matter of grave importance to any organization. Ensuring the safety of workers is a primary goal of most countries, no matter which kind of political system or setup they have. This is because almost no workplace is free from some or another kind of hazard. These workplaces could be as varied as hospitals, construction sites, engineering plants or agriculture and many more.

Governments the world…

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Implementation of Regulatory Aspects of Clinical Research is critical

One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other…

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Understanding Medical Identity Theft and ways of preventing it

Medical Identity Theft is a common phenomenon in today's situation, where most health records are digitized. Although a lot of precaution goes into the security and protection of these records, Medical Identity Theft is a cause for worry.

The most common types of data that are stolen are Social Security Number (SSN), name and the Medicare number, the most potent tools with which to…

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Primary care physicians (PCPs) have been marginalized by Medicare for decades with low reimbursement rates for routine office visits which has led to the 15-20 minute office visit with 10-12 minutes of actual “face time” and a panel of patients that well exceeds 2000. 

Is there a good solution to the Medicare cost and quality issues? Setting aside either the…

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The following was an invited post on Harvard Busines Review web site last Friday.



We have grown accustomed to scientific research producing major medical advances such as those I wrote about in The Future of Medicine — Megatrends in Healthcare. But there are now some very disruptive changes coming in how medical care will be delivered by your doctor or hospital.



Some examples:



Team-based care for chronic illness. The combination of an aging population and… Continue

The following was an invited post on the Harvard Business Review at http://blogs.hbr.org/cs/2010/04/is_technology_a_cost_driver_or.html



Pharmaceutical, biotechnology, and medical-device and equipment companies have been extremely effective at producing innovations that have created major benefits for medical care. But the cost of new patented drugs and devices (pacemakers, defibrillators, stents,… Continue

Recently Conrad Cyburn posted a note about the approach of Kaiser to keep costs down while quality high. They do a good job of avoiding the variations in care that exist across the country and which are part of thereason that caare is both expensive and not as good as it could or should be. There are wide variations in care expenditures from geographic region to region. One might assume that those regions with higher expenditures reap better health but that is simply not the case.… Continue