Whitehall pharmaceutical blog
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A new report accuses pharma companies of using FDA’s risk evaluation rules to unfairly block generic competition.
In June, I blogged about accusations that French drug distribution … more
Boehringer Ingelheim launched a flurry of twitter activity to counter last week’s UK news report claiming regular blood tests would reduce the risk of severe bleeding among Pradaxa patients. … more
The task of matching patients with clinical trials can be made much more efficient by using automated eligibility screening, according to a study published this month in The Journal of The American … more
FedEx has been summoned to appear in San Francisco's federal court a week today to answer charges over the distribution of illegal medicines.
Last Thursday, FedEx and its subsidiaries were … more
The National Medical Device Curriculum is a set of four fictitious case studies intended to help academic institutions and medtech companies understand FDA’s medical device regulatory processes. … more
Whitehall Training’s sister product, ReDA Research Manager, is widely used to run and administer multiple research projects and plays a critical role in leading hospitals, research … more
There is something endearingly old-fashioned about the FDA’s draft guidance on the use of social media. The intention is to provide welcome direction on ways to present risk benefit … more
“Antimicrobial resistance is widely considered to pose one of the greatest risks to modern medicine faced by this generation.” The opening sentence of yesterday’s House of Commons … more
GlaxoSmithKline has recently apologised and sacked its marketing agency for its plan to use a blog to promote clinical trials as a way to fund graduates through unpaid internships.
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French pharmaceutical distribution has been under the spotlight for the last 18 months. Back in December, the French Competition Authority (FCA) published the results of its 10-month investigation … more
I have written somewhat gloomily about the counterfeit drug trade several times and specifically about the widely held belief that whatever steps the industry takes, the pirates seem to be one or two … more
Infonetica products have been accepted onto “G-cloud 5”- the latest version of the UK Government’s digital procurement platform. To be listed on the CloudStore, suppliers need to … more
Safety testing of drugs can be a contentious issue – testing of non-pharmaceuticals is even more so. Opinions are especially polarised where the test systems are live animals. Understandably, … more
This week marked the end of the latest global purge against drug counterfeiters. The international effort resulted in the shutting down of over 10,000 websites, 237 arrests and the seizing of over … more
New “Right to Try” laws aim to bring greater access to new treatments to those with terminal illness in the US – will they work and is this actually a good thing?
The … more
Whitehall Training’s Learning Management System can now be used to create and securely manage your own in-house training.
Whitehall Training has a strong reputation for the quality of … more
TV ads often tell you why one brand is better than the others. Whether it is cheaper, better looking, longer-lasting or simply more effective. Even adverts for painkillers and other OTC drugs will … more
Pharmaceutical pricing has long been a contentious issue. Research is undeniably expensive and shareholders need their pound of flesh too, but are recent price hikes pushing the ethical boundaries? … more
In March, the “I’m In” campaign was launched to encourage African, Asian and Hispanic Americans to participate in US clinical trials. Since then, several states have shown their … more
The regulation of Medical Devices is a tricky area. I have blogged before about the registration process and its critics. Now the FDA is stepping in to fund a project that aims to bring greater … more
The FDA has proposed rules to speed up access to high-risk medical devices that are designed to treat or diagnose serious conditions in patients with whose medical needs are unmet by current … more
A controversial new pharmaceutical vending machine was unveiled in the US last week. It is climate-controlled to keep the contents at peak condition and is designed only to dispense when an … more
Sometimes it seems that researchers need to be reminded that patient safety is the primary consideration of Good Clinical Practice. A heated ethical debate is raging in India over the deaths … more
Do you need a reason for a thorough and transparent pharmacovigilance process… how about nine billion reasons?
A US court has slapped Takeda and Eli Lilly with record damages of $9 … more
Two stories recently caught my eye – very different but with a common message that forms the very core of all good science. Volume is everything.
How many times has the mainstream press run … more
The NHS is either excellent at preventing fraud or rather poor at estimating it.
Official figures put NHS fraud at £229 million – less than one-twentieth of the average level … more
The MHRA’s annual inspections report reveals multiple serious issues involving data protection and even one lethal overdose.
The MHRA’s GCP inspectorate has just published its … more
The UK is to introduce a “fast-track” scheme allowing seriously ill patients who have exhausted other treatments to be given drugs whilst they are still in the trials stage.
The … more
Today, the journal “Vaccine” published an article that could overturn one of the key principles of Good Distribution Practice – that vaccines must be kept cold.
The … more
It’s less than a week since 2014’s Rare Disease Day, an annual event held to raise awareness for rare diseases and improve access to treatment and medical representation for individuals … more
Our best-selling US GCP course has a chapter devoted to draft FDA guidance. There have been several changes since we last updated it in 2013 so it is time to bring it bang up to date. … more
Everyone agrees that pharmacovigilance is a good thing. However, it seems that opinions differ on how much it should cost. Last week, the EU agreed a draft plan to charge fees to cover … more
At Whitehall Training we appreciate that you need to know your training reflects the most recent version of legislation possible. This is why we have a continuous programme of monitoring and … more
In the first of a new regular series, we ask our authors for their opinion on the key issues affecting their area of expertise. In this case, we have spoken with Dr Laura Brown who is Course Director … more
There were two interesting stories in yesterday’s FiercePharmaManufacturing, one showing what can happen when manufacturers feel the wrath of the FDA and the other, lamenting the still large … more
I have blogged several times about the campaign for the full publication of trials results. However, a recent story about sharing confidential data caught my eye. This time, the catalyst was not … more
With clinical R&D spend approaching €5 billion, France is the third-largest trials market in Europe (just behind the UK and Germany). To put this into perspective, 2011 domestic drug … more
Earlier this week, the BBC Radio Four programme “Face the Facts” highlighted the scandalous state of the medical device sector. Their report centred on women who had experienced extreme … more
A recent US case reveals just how important acceptance checks are when receiving deliveries of pharmaceuticals. The case revolves around the import and sale of misbranded Viagra and Cialis.
A … more
Medical devices are incredibly diverse – from the lowliest disposable hypodermic needle to the most sophisticated imaging equipment – but they all have one thing in common. They are all … more
Today, Whitehall Training has launched a new online GCLP course. The course was written by Louise Handy – Chairperson of the Research Quality Association (formerly BARQA – who published … more
According to the current EU Clinical Trials Directive, sponsors must ensure that “provision has been made for the insurance or indemnity to cover the liability of the investigator and … more
The EMA has just concluded its year-long review of Roche’s drug portfolio following its discovery of missing safety data, amounting to tens of thousands of adverse event reports.
The … more
In late October, MEPs (Members of the European Parliament) backed proposals for tighter rules to safeguard patients using medical devices. The rules would not only affect pre-market but … more
Almost half of biotech, pharma and device companies believe that the sophistication of modern counterfeiters is growing faster than the countermeasures used to fight them, according to the 2013 … more
With the publication of Whitehall training’s new course on Device Safety & Vigilance, it is a good time to look at the sector and the strong parallels with pharmacovigilance.
The … more
At the last count, medical trials in India were worth well over half a billion dollars and could pass $1 billion in the next three years. How does this stack up with the recent reports of a freeze … more
The US shutdown has been well publicised and commented on throughout the world. I’m not going to get political about the rights and wrongs of the situation – but what effect, if any, does … more
From last Monday, those wishing to carry out drug research in the UK have been required to register their trials in a publicly-accessible database as a condition of receiving ethics committee … more
Whilst looking for a subject for my Pharmacovigilance blog I stumbled across several internet articles associated with the phrase “death by medicine.” Many of these … more
