04 Aug 06
Because of the ever-increasing costs of healthcare provision the world over, many governments are enacting legislation to promote generic prescription in order to keep costs down. With drugs worth $160 billion in sales coming off patent by 2015, it would seem a good time to be in the generics industry. However the generics market is not without challenges.
03 Aug 06
Manufacturing Instructions and Records: Operators are expected to follow manufacturing instructions to produce a product that meets the required specification. Typically these instructions will be written by technical experts, the chemical engineers who were responsible for the technology transfer, the process validation and so on.
PharmiWeb.com Field Reporter: Joanna Hills
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
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