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Lean Documentation 4

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

Networking Tips

03 Aug 06

Networking: What is it and How do you do it?
Jim Melling - Field Reporter

Preparing for GCP Inspections: The Truth, the Whole Truth, and Nothing But the Truth

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
Triona Coll

Call for guidelines on when to stop or continue drug treatment for Alzheimer’s Disease

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

A Full Pipeline of Follow-on TNF-Antagonists

01 Aug 06

The US$ 7.6 bln market of TNF-antagonists attracts numerous follow-on compounds including improved TNF-antagonists and molecules originating from new technologies
La Merie Business Intelligence

Sheltering under an Umbrella?

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.
Claire Jackaman

Antiarrhythmics: RSD1235 woes reduce market potential but not clinical impact

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.
Datamonitor

New Tools for Mental Health Professionals: Computerised Cognitive Behavioural Therapy (CCBT) in Primary Care

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

Lean Documentation 2b

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

Lean Documentation 2

25 Jul 06

A well-run documentation system will support your business processes and improvements, not hold them back. How do you ensure that this is the case?
Joanna Hills - PharmiWeb Field Reporter

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