Healthcare Regulatory Compliance

If a healthcare organization has to be compliant with regulatory requirements, it has to put the right policies, procedures and processes that help it to carry out important functions such as outlining the expected conduct, training its staff, and ensuring that these are monitored on a regular basis. Areas such as billing, patient care, managed care OSHA, HIPAA privacy and security, and reimbursement are just some of the areas that come under healthcare compliance.

A Tour of Health Canada

Health Canada is to Canada what the FDA is the US. It is Canada's regulatory body which regulates all aspects of medical and pharmaceutical products. A tour of Health Canada is to survey its purview of work more...


European Regulatory Procedures - a brief introduction

Biosimilars are being considered the next major phenomenon to hit the US pharma market. This is because they offer a viable and relatively cheaper alternative to drugs, many of which carry extremely steep price labels. more...


European Union regulatory issues for cosmetic products - the EU Regulation 1223/2009

Tasked with regulating a huge market consisting of half a billion consumers and generating about a third of the world's total economic output; the European Union (EU) has quite an unenviable task on its hands. Cosmetic products are among the primary areas of European Union regulatory issues, because they account for a huge market. more...


Filing Variations in the European Union

Whenever the European Union requires a drug manufacturer to make changes into the product be they minor, substantial or major; there are rules within the European Union about how to report these changes. These changes could be in relation to the quality of the drug, its safety or to its indications. These are what are called filing variations in the European Union, because the manufacturer has to file for these variations more...


Food Microbiology is a vital area in ensuring food integrity

Food microbiology is a fairly large field of the science of food. Any food, no matter from which source it is derived, which part of the world it is grown in, and what it contains, is prone to attracting microorganisms. These microorganisms, found freely in nature, inhabit food. Although not all microorganisms are necessarily bad, bad ones among these microorganisms can have an impact on food. Their nature and inhabitation in food call for a separate topic of biology, namely food microbiology. more...


GMPs for OTC and Cosmetic Products

Over the Counter (OTC) and personal care or cosmetic products constitute a very huge market in the US and the EU. Since they are in very wide usage in these huge markets; they are regulated. more...


Business Process Management in Healthcare helps reduce inefficiencies

For many years before the advent of automation and computerization ,healthcare processes, such as billing, admissions, and many elements of care were carried out manually. Although it was a capable method to quite an extent, it relied on the use of the manual process or the human method. This was always prone to mistakes and errors, because humans are prone to committing errors that can creep in even with the best of intentions, as a result of which the healthcare industry ended up losing billions of dollars that could otherwise have gone into meaningful forms of investment. more...


Japanese Institutions and Regulatory Authorities

Japanese institutions and regulatory authorities are organized in a rather complex way, with a few institutions and regulatory authorities being responsible for the oversight of regulating pharmaceuticals, and a few others, purely for developing pharmaceuticals. more...


Bringing about Healthcare Process Improvement

With healthcare changing at a breakneck speed it is necessary for healthcare providers to keep pace with it. Healthcare activities keep changing at the drop of a hat, making it imperative for healthcare providers to come up with action plans for being prepared to absorb all the changes. For this to happen, they need to put a healthcare process improvement plan in place. Implementing a process driven approach is of paramount importance, because no other system works as well. A healthcare process improvement plan is essentially about putting processes in place in the healthcare chain, so that even in the absence of particular individual or with a change in the system; the process goes about unaffected. more...


The Healthcare Simulation Process

Simulation is one of the defining factors of any automated environment. Simulation is commonly understood as the method by which an action is replicated or imitated with the help of tools and technologies. Offering a near-natural, real-life kind of feel of a product or service is where simulation helps. more...


Understanding an HPLC system

In analytical chemistry, a High Performance Liquid Chromatography (HPLC) system is used for the purpose of separating, identifying, and the quantifying each of the various components that make up a mixture. A pressurized liquid solvent that contains the sample mixture uses pipes to pass through a column filled that is with a solid adsorbent material. An HPLC system is built in such a fashion that each component that goes into the sample has its own way of interacting with the adsorbent material. Each of these could be slightly different, as a result of which different components have different flow rates. As a result, components are separated in the process of flowing out of the column. more...


Regulatory Filing Requirements for medical devices in Japan

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 relatively less complex than those of the US and Europe and other markets more...


What is risk-based monitoring?

Sponsors of clinical studies adapt many methods that are aimed at reducing the complexity of clinical trials. They also look for methods by which they can increase the efficacy of the results, while keeping the costs low. Risk-based monitoring is one of these methods. more...


The increasing role of the social media in healthcare

With the social media having moved beyond being a platform for sharing personal information its role in healthcare has nearly exploded of late. This is mainly because the growth of the social media has more or less coincided with that of the electronic records in healthcare. more...

Copyright © 2017 GlobalCompliancePanel. All rights reserved. Netzealous