02 Aug 06
Every sponsor or CRO can expect their country’s regulatory agency to arrive on their premises periodically to conduct routine inspections. In the UK, for instance, the Medicines and Healthcare products Regulatory Agency (MHRA) conducts routine periodic inspections approximately every three years. Apart from these, the MHRA also conducts “for cause” and “follow up” inspections, and they also take part in the third-country inspection program. Because all inspections may be either announced or unan
01 Aug 06
Dr Mark Ballard, the Medical Director of Respiratory and Dermatology Therapeutic Areas at the Novartis Pharmaceuticals Corporation answers our questions about their eczema cream Elidel.
01 Aug 06
Doctors taking part in a survey on Alzheimer’s Disease (AD) management have called for clear and consistent guidelines on diagnosis and treatment of the condition to be drawn up as a matter of urgency. The survey was sponsored by Eisai Europe Ltd and Pfizer Inc, who market the cholinesterase inhibitor Aricept (donepezil), and was presented during the International Conference on Alzheimer’s Disease and Related Disorders.
Olwen Glynn Owen – Pharmiweb Field Reporter
31 Jul 06
The Treasury is aware of a growing trend, which has recently moved into the pharmaceutical sector, for staff to be provided to clients through “umbrella” or “composite” companies. These companies promise a golden scenario of reduced costs to their clients and greater take-home pay to the individuals who work through them.
31 Jul 06
Atrial fibrillation (AF) is the most common form of arrhythmia, or irregular heartbeat, with an estimated nine million sufferers worldwide. Although safe, effective treatment for AF is critical, historically there has been little R&D investment and little innovation in the AF market. However, this may be about to change, with the AF market expected to triple by 2015.
25 Jul 06
Cognitive behaviour therapy (CBT) combines two very effective kinds of psychotherapy delivered face to face by medical therapists
Jim Melling - PharmiWeb Field Reporter
25 Jul 06
In the last report we analysed part of an SOP control system for inefficiencies and opportunities for error, by mapping the system and asking ‘what if?’ at each stage. But, as we mentioned previously, documentation systems (or, indeed, any type of control system) rarely operate in isolation. So let’s look at some of the inputs and outputs there might be on a typical site, using the same process as before.
Joanna Hills - PharmiWeb Field Reporter
21 Jul 06
PowderMed has submitted an application to UK regulators seeking to conduct human trials of its avian influenza vaccine. Developing an effective vaccine against the next influenza pandemic is a challenging task, but one many companies are taking on. However, until a virus able to cause a pandemic emerges, no one knows for certain which product will be most effective.
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