Whitehall Training’s US GCP course has received a major update – we look at just what has changed since it's last major update, just over two years ago…
To paraphrase ex UK … more
Whitehall pharmaceutical blog
Pharmacovigilance is so much easier within the confines of a clinical trial. Everything is under close medical observation, any concomitant medication is well-known, and cause and effect is fairly … more
With Russia taking up so many column inches in the Western press (not all wanted) it seems a strange time to be investing in clinical trials there. However, a perfect storm of factors including easing … more
One in ten high school seniors in the US admits to abusing prescription painkillers. Painkillers are the second-most popular choice for those using illicit drugs for the first time in the US. Of … more
£1.49 billion is the upper estimate of the cost of fraudulent payroll claims made by agency staff working for the NHS, according to a report published this week. The NHS spends approximately … more
A recent Gallup poll has revealed that the US public takes a dim view of the pharmaceutical industry. Every year, Gallup asks people in the US whether they have positive or negative views of 25 … more
Australia currently accounts for less than 3% of global clinical trials (as logged in https://clinicaltrials.gov) and yet is a unique and attractive location for trials for several reasons. Something … more
The Medicines and Healthcare products Regulatory Agency (MHRA) is assessing the feasibility of conducting stand-alone inspections of pharmacovigilance contract service providers.
The move reflects … more
A judicial review brought by Richmond Pharmacology against the Health Research Authority (HRA), has been upheld by a High Court Judge. The company argued that the HRA had overstepped the law by … more
The UK’s Competition and Markets Authority has released a preliminary report that criticises the massive increase in the price of the epilepsy drug, phenytoin. When the drug was sold by Pfizer … more
The recent Ebola epidemic and the resultant flurry of research activity made me wonder about the ethics of blinded placebo trials when the disease is this lethal. Merck’s trial of rVSV-ZEBOV … more
The European Union (EU) has banned the marketing of around 700 generic medicines because of alleged manipulation of clinical trials conducted by Hyderabad-based GVK Biosciences. The EU-wide suspension … more
The Institute of Economic Affairs (IEA) has published a report arguing that UK government research funding is encouraging “pointless” research and skewing research priorities as … more
I always thought headache pills were white because that makes them cheaper to make – how naïve of me! According to a recent study, people are more likely to believe that … more
The US Food and Drug Administration (FDA) is facing a lawsuit for failing to respond to a freedom of information request covering a trial of two Hepatitis C drugs.
The request covers Gilead … more
Ten of the world's largest drugs manufacturers, including Johnson & Johnson, Pfizer and AstraZeneca, are taking part in a TransCelerate-run project, which aims to create a secure supply chain for … more
The CIA has come in for a lot of public criticism over the last few years, centring on its treatment of prisoners. A fresh argument has reared its head, suggesting that the CIA may have broken the … more
Today, the UK MHRA (Medicines and Healthcare products Regulatory Agency) announced biggest haul of counterfeit and unlicensed medicines in the agency’s history – almost double its total … more
The MHRA is surveying UK healthcare professionals to discover the best ways to keep patients informed when a drug’s risk profile changes.
The survey forms part of initiative, SCOPE - … more
The MERS (Middle East Respiratory Syndrome) virus has not received the same hysterical media coverage as Ebola but it has already killed at least 444 and infected over 1,200. South Korea has the … more
What does the word “imminent” mean to you?
In the case of the start of a trial for a drug to help children with the most severe epilepsy, it means well over a year away with no … more
Apparently, NHS patients admitted to hospital on a Sunday are 16% more likely to die in hospital than those admitted on any other day. This fact nicely demonstrates the danger of … more
India has been vocal about investment in its pharmacovigilance programme over the last year. However, despite being a US$ 3.1 billion market for medical devices, it has no equivalent process for … more
Many paediatric studies depend upon the collection and storage of biological material from children with the condition being investigated. A paper recently published in Nature examines the legal … more
The British Medical Journal has alleged that Novartis has been using some shady practices to hinder trials comparing Lucentis and Avastin for wet age-related macular degeneration.
For many … more
The latest Canadian implementation of Whitehall Training’s sister product, Ethics Review Manager, was officially launched by Clinical Trials Ontario (CTO) earlier this month under the name of … more
Some reports claim that as many as 90% of adverse drug reactions go unreported. Will moves to widen the net of pharmacovigilance fill in the gaps or will it point to previously unsuspected ADRs? … more