Whitehall pharmaceutical blog
Click to receive updates & special offers
In August, the FDA issued final guidance on using a risk-based approach in clinical investigations. These should not only raise the standards of monitoring but save money too! The new guidelines … more
This month sees the commercial launch of an invention that could make the detection of counterfeit drug that bit simpler.
The guidance under GDP for recognising fake medicines ranges from the … more
The Whitehall Training course platform was designed with flexibility and ease of learning in mind. Now, we have produced three, illustrated user guides to help new administrators and learners get … more
Around 50% of the drugs approved for adults in the US are being used in children, even though their safety and effectiveness had not been established for this use. Last week, FDA announced further … more
Japan is the second-largest pharmaceutical market in the world. It stands to reason that its clinical research regime is also one of the most highly developed and tightly regulated. … more
Last month, I wrote about the publication of full trial data and specifically, whether selective publication is ever justified. The debate rages on thanks to a "leaked" memo and a UK newspaper… … more
On 11th March 2012, “mild-mannered” Staff Sgt Robert Bales shot and killed 16 Afghan citizens and wounded a further six – in what is now dubbed “The Kandahar massacre.” … more
It’s easy to focus on the aspects of GDP that control the complex journey from manufacturer to patient. But a recent US court case highlights the role GDP should play in protecting patients … more
Consultation on the European Medical Association’s draft policy on the publication and access to trial data ends on 30th September. What will it mean if the policy comes into force in January … more
The European Union's GDP (Good Distribution Practice) guidelines will pass into law on 8th September 2013. Are you prepared for the changes?
Whether you are operating within the EU or … more
The Q&A session at the MHRA Pharmacovigilance symposium on 26th March highlighted a lot of uncertainty over off-label usage. There is even confusion over what “off-label” actually … more
At the Pharmacovigilance symposium held in London on 26th March, a delegate asked how the MHRA would recommend that small companies assess the effectiveness of training. The response was clear: … more
Is the US no longer a safe harbor?
Opinions are polarised over the actions taken by US NSA whistleblower/criminal Edward Snowden. Should he be hailed as a hero or branded a … more
ICH-GCP Online Training Course Adapted for Germany in German
Germany has a vibrant clinical trials sector – home to around 7% of the world’s studies, and 1.2% of its population. … more
Are You Prepared For The FDA’s Upcoming Sunshine Act?
The US FDA has measures in the pipeline that aim to ensure clinical trials are carried out ethically and for the right reasons. Under the … more
Download our self-assessment audit checklist
The recently-revised European pharmacovigilance regulations shift the emphasis of the audit process to the marketing authorisation holder. Now you must … more
What is Pharmacovigilance?
Pharmacovigilance and drug safety were developed to prevent another Thalidomide disaster. The present day approach to drug safety and adverse event reporting … more
