Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
Three Reasons to Adopt Automated Validation in Quality Management Systems
August 10th 2012My daughter has been learning how to ride a bike for the past year. She’s actually become quite adept at it, and for someone who loves to cycle, I am certainly proud. But there were certain obstacles to overcome to get to this point. We started simply with the tricycle – learning to pedal.
EC Investigates Lundbeck for Potential Pay-to-Delay Agreements
July 27th 2012The European Commission has issued a statement of objections against Lundbeck and several other pharmaceutical companies with the preliminary view that Lundbeck formed agreements with generic-drug companies to prevent the market entry of cheaper versions of its antidepressant, citalopram.
UK Mulls Access to Unlicensed Medicines
July 24th 2012The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently launched a 12-week public consultation for a national scheme that will look at the possibility of providing seriously ill patients with access to unlicensed medicines still in Phase III, or possibly even Phase II, clinical trials
EMA Investigates Roche for Deficiencies in Safety Reporting
June 28th 2012The European Medicines Agency has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.
EFPIA Calls for Urgent Action on German Pricing
June 14th 2012The European Federation of Pharmaceutical Industries and Associations has called for the German government to take "urgent action" regarding its pricing system, which is perceived as hindering the market entry of new, innovative medicines in the country.
Parallel Trade Fuels UK Drug Shortages
May 22nd 2012A bill has recently been in discussion in the US that contains measures to strengthen the ways in which drug shortages are dealt with. The US FDA is also taking action by asking companies to alert them as to possible drug shortages so that it can prepare back ups.