30 Aug 06
In an earlier field report, we looked at some of the issues surrounding manufacturing process instructions (MPIs) and manufacturing process records (MPRs). I want to look at the issue of recording data in MPRs in more detail, as the format of your MPR has a huge impact on its usability and therefore the error rate.
PharmiWeb.com Field Reporter: Jo Hills
23 Aug 06
Paul Hawkins, the General Secretary for the Health and Beauty Association, tells us his philosophy for career progression and how the H&BA’s new website will help them to progress. The website itself promotes HBA’s attempt to bring Health and Beauty companies together in debating and discussing how to develop and adapt the industry to meet changing customer and consumer needs. Paul hopes the move towards e-business will do just that.
22 Aug 06
You may not exactly be breaking into the gold vaults at Fort Knox, scaling the heights of MI5 à la James Bond or hacking into The Pentagon security system, but you want to enter the pharmaceutical industry, which can be nearly as difficult.
18 Aug 06
With overall healthcare spending set to continue rising, payers are implementing cost containment measures, increasing the importance of developing a robust and flexible pricing and reimbursement (P&R) strategy. In formulating and adapting a P&R strategy, it is vital for drug developers to understand how P&R fits into the US healthcare market, and to identify the different types of P&R controls.
16 Aug 06
The versatility of the vascular endothelial growth factor (VEGF) signalling pathway as a validated target and its excellent tractability explain a crowded field of drugs of all classes
La Merie Business Intelligence
09 Aug 06
The protection of intellectual property (IP) rights has become crucial to the success of many foreign investors and enterprises who wish to profit from China’s fast growing market. As many foreign investors have discovered that counterfeiting, passing off and other forms of IP infringement are common in China. At the same time, Chinese companies are investing heavily in sophisticated technology and require an effective IP system to protect their own investment.
The dynamics of protecting inte
08 Aug 06
Andy Sarfas is our mover and shaker of the week. He is the Global Internet Business Manager for Reckitt Benckiser.
08 Aug 06
David Mitchell is the Commercial Director at McNeil Consumer Healthcare, a company that produces remedies for self-treatment available at pharmacies and supermarket stores.
08 Aug 06
Alex Bishop is the IT Business Manager at Pfizer, the largest supplier of medicines to the NHS.
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
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.
20 Jul 06
Treatment of chronic kidney disease (CKD) is focussing increasingly on prevention of cardiovascular complications with the aim of reducing the cardiovascular mortality and morbidity to which many patients currently succumb.
Olwen Glynn Owen - PharmiWeb Field Reporter
19 Jul 06
Hints and Tips: Survive in the Work Place Part Two
Elaine Ford - PharmiWeb Field Reporter
13 Jul 06
'Drug In Focus' is written by Leighton Howard, a patent information expert with extensive generics experience. He has worked within the professional patent information industry and major generic pharmaceutical firms and now provides consultancy services to the generics industry and government organisations via his company XIP Pty Ltd. He is also the founder of GenericsWeb and remains instrumental in maintaining the high quality and accuracy of data contained in Pipeline Patent Intelligence.
13 Jul 06
Despite not being a widely acknowledged affliction, urinary incontinence (UI) is a relatively common condition, with up to 23% of the female population suffering from one form alone. Yet despite the significant impact UI can have on the quality of life of the sufferers, according to a new report, approximately half of sufferers neither seek treatment nor report the problem to a physician.
10 Jul 06
ROCHE is set to file for a new indication for its oral, targeted cancer drug Xeloda® following impressive new data presented at the American Society of Clinical Oncology conference (ASCO).
09 Jul 06
Pharmaceutical companies are renowned for exhaustive pages of regulatory reports and documentation procedures. An enormous amount of effort goes into creating and maintaining these documentations, usually by people for whom it is only a small part of their job.
Another problem is that complexity exists in such documents and may be due to an excess of information or to inappropriate structure. Again, historically there may have been a drive to put every little detail into the procedures, in t
PharmiWeb Field Reporter -Joanna Hills
07 Jul 06
Todays Headlines from across the DailyUpdates network (July 7th, 2006) - In today's edition we highlight Biomarin's development of the novel antihypertensive 6R-BH4 and new research describing a promising molecular target for future sepsis therapeutics.