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September 2017 Blog Posts (60)

Pharmaceutical companies gave $12m to doctors, nurses and pharmacists

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Pharmaceutical companies gave Australian doctors, nurses and pharmacists almost $12m in fees and expenses to attend conferences and give talks between November 2016 and April 2017.

The payments comprised more than $6.5m for travel expenses and accommodation; more than $4.2m in speaking and consultancy fees; and more than $700,000 to cover registration at medical conferences and events.

The drug companies Bristol-Myers Squibb and…

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Added by John Robinson on September 12, 2017 at 6:07am — No Comments

A clear process for compliant laboratory OOS investigations

The core of successful operation by a drug maker is laboratory testing. current Good Manufacturing Practices (cGMP) regulations require a drug manufacturer to use laboratory testing as a tool to validate that everything that goes into a laboratory product, such as in-process materials, finished materials, and containers adhere to set specifications. When all these are done, a major challenge for laboratories is in how to deal with a test that shows an…

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Added by Adam Fleming on September 12, 2017 at 5:59am — No Comments

Education, training and tools for ensuring healthcare frontline food safety

Food technology has been growing at a quick pace, having come under the influence of the twin paradigms of the late 20th century, technology and globalization. As populations keep moving from one part of the world to another in the millions; it is natural that they get influenced by the food behavior of the place to which they move, while also bringing their own influences into it.

It is not just with the itinerant population that food service and movement are paired and…

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Added by Roger Steven on September 11, 2017 at 7:20am — No Comments

The importance of meeting Supplier Management criteria

The importance of meeting Supplier Management criteria

Meeting the supplier management criteria set out by the FDA, the ISO and the QSR regulations is mandatory for the regulated industries. The qualification and assessment of suppliers is binding for the regulated industries. Being in compliance with the requirements for supplier management set out by the FDA and by the ISO…

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Added by John Robinson on September 11, 2017 at 6:18am — No Comments

Psychiatric care is postcode lottery, say medical experts

Psychiatric care is postcode lottery, say medical experts

There are not enough NHS psychiatrists in some parts of the UK and more should be recruited to improve care, says the Royal College of Psychiatrists.

In Scotland, there are 10 consultant psychiatrists per 100,000 people – but only eight for the same number in England and Northern Ireland, and just six in Wales.

London’s tally…

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Added by John Robinson on September 11, 2017 at 6:04am — No Comments

Role of ‘technology’ in home health care

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At present, home-based health care is gaining significant traction and poised for transformation. Once recognized as a fragmented and unorganised sector, it is gaining ground through progressively capturing interest of entrepreneurs and investors.

It is a known fact that there is tremendous pressure on hospitals in delivering services at their facility, especially in Critical Care, something that can be easily outsourced…

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Added by John Robinson on September 8, 2017 at 6:14am — No Comments

How to Recognize the Hazards of Blood Borne Pathogens

Bloodborne pathogens are those microorganisms present in the human blood that carry infection. These infections can cause disease in humans. The major bloodborne pathogens that cause infections in humans are:

o  Hepatitis B (HBV)

o  Hepatitis C (HCV)

o  Human immunodeficiency virus (HIV)

Although these are the main disease causing pathogens; there are many more. So, hospital staffs who deal with patients who are infected by…

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Added by Adam Fleming on September 8, 2017 at 5:46am — No Comments

Complementing MACRA and MIPS with HIPAA brings about better patient engagement

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is a federal Act that regulates the manner in which physicians have to be paid when they treat patients who come to them under Medicare. It modifies and supersedes the earlier legislation on this topic, namely the Balanced Budget Act, which was in force from 1997. 

From the time the Balanced Budget Act linked physician payments to budget cuts and economic growth; it has reduced physician payments by over a fifth. In…

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Added by Roger Steven on September 7, 2017 at 7:32am — No Comments

How to Overcome Regulatory and Compliance Pain Points for Companies? - Just Register for $10 Training

If as organizations in the regulated industries, you had lost hope of how to overcome regulatory and compliance pain points, all that you need to do is register for GlobalCompliancePanel’s $10 training!

Yes, $10 is all it costs to overcome regulatory and compliance pain points for companies. Just register for GlobalCompliancePanel’s $10 training, and you are done. How does a company every…

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Added by John Robinson on September 7, 2017 at 6:39am — No Comments

CURE Pharmaceutical Launches New Academic Partnership Program Providing the Company’s Proprietary CureFilm™ for More Humane and Effective Animal Research

OXNARD, Calif., Sept. 06, 2017 (GLOBE NEWSWIRE) — CURE Pharmaceutical (OTCQB:CURR), (“CURE”), a leading disruptive drug delivery technology…

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Added by John Robinson on September 7, 2017 at 5:54am — No Comments

US pharmaceutical company expands Dublin presence

US pharmaceutical company expands Dublin presence

PTC Therapeutics, a US pharmaceutical company, plans to expand its European headquarters in Dublin to 40 staff.

The Dublin site of the company is responsible for finance, quality assurance, legal and a raft of other back office roles.

“We currently employ 30 people in the…

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Added by John Robinson on September 7, 2017 at 5:51am — No Comments

Navigating the nuances of the Internet of Medical Things

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Earlier this year, Gartner released a forecast for the Internet of Things (IoT)predicting that 8.4 billion connected things will be in use worldwide in 2017 and that total spending on endpoints and services will reach almost $2 trillion this year. This forecast is certainly encouraging, but due to the prevalence and influence of the Internet of Things in almost all business arenas, it’s not…

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Added by John Robinson on September 6, 2017 at 6:53am — No Comments

What is the legal language of the FDA form 1572 or Device equivalent?

Form FDA 1572 is one of the primary documents needed when carrying out a clinical trial. Also called the Statement of Investigator; Form FDA 1572, called just 1572 informally, is a contract between the Principal Investigator (PI) and the FDA. This form contains all details of the subjects, as well as commitments from the PI.

It is a contract in which the Principal Investigator, the person who is…

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Added by Adam Fleming on September 6, 2017 at 6:11am — No Comments

OSHA Proposes Extending Compliance Deadline for Crane Operator Certification Requirements to 2018

OSHA Proposes Extending

The Occupational Safety and Health Administration (OSHA) today issued a Notice of Proposed Rulemaking to extend the employer’s responsibility to ensure crane operator competency and enforcement for crane operator certification to Nov. 10, 2018.

OSHA…

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Added by John Robinson on September 5, 2017 at 7:29am — No Comments

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

 

Most pharmaceutical biofilms, especially those in water systems, suffer from one major flaw: misconceptions. Strict and rigid rules for design and operations, especially when they are built on…

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Added by John Robinson on September 4, 2017 at 6:34am — No Comments

How to Achieve the best Outcome in an Audit

An internal audit, as we all know, is carried out for a number of specific purposes, the main one among which is to assess the adherence to the industry guidelines for quality and processes. Helping the organization meet the requirements of processes and standards, which are usually issued by regulatory agencies and other relevant bodies and boards, is the main aim…

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Added by Adam Fleming on September 4, 2017 at 5:36am — No Comments

HIPAA’s guidelines need to be understood to prepare for, prevent, respond and recover ransomware

Ransomware is dangerous and malicious software that infects the operating systems of computers that are vulnerable. It blocks access to files, and demands a ransom for releasing it. After the ransom is paid, usually in the form of virtual cash, through means such as Bitcoin, the block may be released. Many ransomware attacks, like ransom seekers in real life, blackmail and harass the victim for prolonged periods of time. Sometimes, ransomware can block the user’s access to the entire…

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Added by Roger Steven on September 1, 2017 at 7:47am — No Comments

cGMP Data Integrity is of Critical Importance

Of late, the FDA has been turning on the heat on manufacturers in the FDA-regulated industries that violate its regulations. It has a penchant for going after manufacturing facilities that show laxity in implementing current Good Manufacturing Practices (cGMP). This ardor is understandable. cGMP violations affect the quality of the product; hence the strictness, considering that it is patients who consume these products.

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There are ways of ensuring that the product…

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Added by Adam Fleming on September 1, 2017 at 6:05am — No Comments

Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research.

The Value and Importance of Health Information Privacy

Ethical health research and privacy protections both provide valuable benefits to society. Health research is vital to improving human health and health care. Protecting patients involved in research from harm and preserving their rights is essential to ethical…

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Added by John Robinson on September 1, 2017 at 5:42am — No Comments

Hipaa—Should I Be Worried?

This ongoing column is dedicated to providing information to our readers on managing legal risks associated with medical practice. We invite questions from our readers. The answers are provided by PRMS, Inc.  a manager of medical professional liability insurance programs with services that include risk management consultation, education and onsite risk management audits, and other resources…

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Added by John Robinson on September 1, 2017 at 5:41am — No Comments

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