Articles

Effective regulatory information management (Reg IM) is about so much more than compliance – or it could be, if only pharma organisations were tuned in to the wider commercial advantages. Yet, according to a recent survey, only 20% of life sciences companies have so far fully implemented a formal Reg IM strategy. Adam Sherlock, director at CSC Life Sciences, expresses his surprise
Effective regulatory information management (Reg IM) is about so much more than compliance – or it could be, if only pharma organisations were tuned in to the wider commercial advantages. Yet, according to a recent survey, only 20% of life sciences companies have so far fully implemented a formal Reg IM strategy. Adam Sherlock, director at CSC Life Sciences, expresses his surprise.In the data-dense world of pharma…

“First law on holes - when you're in one, stop digging!”
“First law on holes - when you're in one, stop digging!” Denis Healey, former UK Finance Minister.It is clear that Drug Discovery is in a “hole”. The worries about the patent cliff, and the slowing rate at which new drugs are discovered is well documented. So Denis Healey’s advice is pertinent. Instead of working feverishly harder at what has worked in the past, perhaps standing back to look more reflectively might be the way forward. In a way, standing back and being reflective is what Universities are for. So the University of Edinburgh is offering a Distance Learning course to take a fresh look at the problem.But this reflection is not from the ivory tower. Three people behind the course have close up experience of the rough-and-tu…

No, not the title of a new murder-mystery novel, but the facts of a case involving J Sainsbury PLC concerning the issue of “Vicarious Liability”. “Vicarious Liability” is the phrase used to describe the situation where a third party is responsible for acts committed, not by itself, but by another under its control.
No, not the title of a new murder-mystery novel, but the facts of a case involving J Sainsbury PLC concerning the issue of “Vicarious Liability”. “Vicarious Liability” is the phrase used to describe the situation where a third party is responsible for acts committed, not by itself, but by another under its control. Often in the employment relationship, the employer is said to be responsible (or vicariously liable) for the acts of its employees whilst they are “at work”. Howe…

The essential resource for implementing sustainable packaging labelling and artwork capabilities.
Packaging artwork is an often forgotten back room process in most pharmaceutical companies. However, the changing business environment has brought issues from this capability to the fore, as pharmaceutical and healthcare companies face one of the most difficult periods in their history.A new book from a former GlaxoSmithKline (GSK) head of global packaging design describes the key capabilities required to deliver right-first-time packaging artwork in today's environment. It also discusses potential future developments in the area to help the reader design any improvement activity with these in mind.It’s the essential resource for implementing sustainable packaging labelling and artwork capab…

A biologist’s job description may range widely depending on the area of specialty. A biologist is a scientist who studies life in one of its many forms, and a work settings can also range from a classical laboratory to field work in various environments and climates.
A biologist’s job description may range widely depending on the area of specialty. A biologist is a scientist who studies life in one of its many forms, and a work settings can also range from a classical laboratory to field work in various environments and climates.Biologists may study life on land, water, or air. They may study the smallest microbes or whole interlocking systems of life. Just a few of the possible kinds of biologists areAquatic biologists – Study all organisms, plats, and animals that live in waterMarine biol…

“Need a degree to get a pay rise – don’t bother if you’re 61 or older!” “Want to work beyond the age of 65 – afraid not, it’s in our Partnership Deed!” These may sound like the worst job adverts in the world, but in fact they are the subject matter of two cases whose judgments were handed down by the Supreme Court last week (25 April 2012). These key cases are set to challenge employer’s attitude to age and retirement.
“Want to work beyond the age of 65 – afraid not, it’s in our Partnership Deed!” These may sound like the worst job adverts in the world, but in fact they are the subject matter of two cases whose judgments were handed down by the Supreme Court last week (25 April 2012). These key cases are set to challenge employer’s attitude to age and retirement. What will these…

Cherwell Laboratories, specialists in products for environmental monitoring and the validation of sterilisation processes, will be exhibiting at the Pharmaceutical & Healthcare Sciences Society (PHSS), Aseptic Services Pharmacy Training Course on the 13th June.
Cherwell Laboratories, specialists in products for environmental monitoring and the validation of sterilisation processes, will be exhibiting at the Pharmaceutical & Healthcare Sciences Society (PHSS), Aseptic Services Pharmacy Training Course on the 13th June. The PHSS event, to be held at Crewe Hall, Nr Crewe Cheshire, has been designed in collaboration with the NHS and regulatory bodies and covers the aseptic use of pharmacy isolators. It will be of particular benefit to individuals within the NHS and contract providers in…

There has never been so much data in the world as there is now - how can pharmaceutical companies make sense of these increasing volumes of data, both for marketing and regulatory purposes? Stephen Dunnigan of business intelligence firm MicroStrategy looks at how technology can help unlock the potential of big data.
There has never been so much data in the world as there is now - how can pharmaceutical companies make sense of these increasing volumes of data, both for marketing and regulatory purposes? Stephen Dunnigan of business intelligence firm MicroStrategy looks at how technology can help unlock the potential of big data.The pharmaceutical industry has always been one that creates large volumes of data. The leading companies are large, multi-national organisations with an on-going an…

As both social media and webcasting continue to evolve at a rapid rate the pharmaceutical sector continues to innovate and evolve the ways in which it communicates to diverse and geographically spread audiences.
As both social media and webcasting continue to evolve at a rapid rate the pharmaceutical sector continues to innovate and evolve the ways in which it communicates to diverse and geographically spread audiences. In such an ever changing environment it is difficult to keep on top of what ‘best practice’ actually is, and how new technologies can enable more engaging conversations with stakeholders.The webcast has now become a standard part of the toolkit for communications teams to create connections between Key Opinion Leaders (KOLs), stakeholders and journalists. However with the c…

Oncology products dominate the global therapeutics market, and are on course to reach an estimated €56 billion in sales by 2015. While cultural differences in approaches to treatment and research into cancer undoubtedly exist between countries, investigators throughout the European Union have adopted similar approaches to the rigorous evaluations of novel oncology treatments in Phase I clinical trials. But such trials are not conducted without reference to a number of considerations.
Oncology products dominate the global therapeutics market, and are on course to reach an estimated €56 billion in sales by 2015.1 While cultural differences in approaches to treatment and research into cancer undoubtedly exist between countries, investigators throughout the European Union have adopted similar…

In a fast growing healthcare sector- healthcare HR has to answer to critical demands that other industries do not face. From complying with very tight government regulation and processes to the need to ensure staff competence, more and more healthcare organizations are implementing talent management and workforce planning solutions to answer to the ever-increasing demands of the field
In a fast growing healthcare sector- healthcare HR has to answer to critical demands that other industries do not face. From complying with very tight government regulation and processes to the need to ensure staff competence, more and more healthcare organizations are implementing talent management and workforce planning solutions to answer to the ever-increasing demands of the field. With an effective talent…

Gone are the days of highly customized, heavy footprint technologies with complex, over-engineered work streams. The Regulatory industry is looking for a kinder, gentler solution that doesn’t require teams of support personnel to install and validate a software update.
Gone are the days of highly customized, heavy footprint technologies with complex, over-engineered work streams. The Regulatory industry is looking for a kinder, gentler solution that doesn’t require teams of support personnel to install and validate a software update. They are looking for a simple approach that supports daily operations, without requiring budget-busting licensing fees. And they have found it in SaaS (Software as a Service).Software as a service, also known as SaaS, is not a new concept but it has made a rel…

In complex therapeutic areas such as oncology, thought leaders have long sought improvements to lengthy trials, hit-or-miss treatments and soaring research costs.
In complex therapeutic areas such as oncology, thought leaders have long sought improvements to lengthy trials, hit-or-miss treatments and soaring research costs. While there is still much to be resolved, the rise of personalized medicine has set its sights on these and other obstacles in the pursuit of more targeted and efficient therapies.The one-size-fits-all approach that has dominated clinical drug development has been the most appropriate route when costs are considered, but this strategy has failed to meet the needs of the patient. Guesswork has dominated drug development for far too long, leading to a push to make drugs me…

Until 1st October 2011, most businesses adopted the default National Retirement Age (NRA) of 65 for their staff. Under the then law, employers had the right to retire employees at 65, provided they followed the statutory retirement procedures.
Until 1st October 2011, most businesses adopted the default National Retirement Age (NRA) of 65 for their staff. Under the then law, employers had the right to retire employees at 65, provided they followed the statutory retirement procedures. If such procedures were followed, such a dismissal would be neither unfair nor amount to age discrimination.Under external pressure from Europe and some internal pressure from organisations like Age UK, the Coalition Government scrapped the NRA and the statutory retirement procedures. On the same day that…

If you are a person who has a knack for convincing others to follow your lead and you have a special curiosity in the sciences, you could be the perfect candidate for a career in pharmaceutical sales. A positive, proactive attitude and a fierce determination to succeed are all important qualities in pharmaceutical sales.
If you are a person who has a knack for convincing others to follow your lead and you have a special curiosity in the sciences, you could be the perfect candidate for a career in pharmaceutical sales. A positive, proactive attitude and a fierce determination to succeed are all important qualities in pharmaceutical sales.One aspect of pharmaceutical sales that is particularly appealing compared to other markets is that jobs in this field tend to have a higher salary. The pro…

If the world of pharmaceuticals is a fascinating one for you, particularly understanding the nature of medicines, metabolism and drug interactions, then a career in pharmacy may be a solid match for you.
If the world of pharmaceuticals is a fascinating one for you, particularly understanding the nature of medicines, metabolism and drug interactions, then a career in pharmacy may be a solid match for you. Pharmacists are dispensers of prescription medications to patients. They offer education on the medications and they support patients by helping them to learn about the directions for taking the drugs as well as clarifying information from the patient's primary physicians. Pharmacists also monitor for drug reactions and keep up-to-date on the progress and health of patients. In this way, a…

Pharmaceutical brand managers have the task of bringing success to a brand's lifecycle. Every brand has this lifecycle – where it is introduced to the market before it eventually 'dies' out. People who work in this role will want to make that brand as successful as possible while extending its lifecycle as much as they can to get more profits out of the drug.
Pharmaceutical brand managers have the task of bringing success to a brand's lifecycle. Every brand has this lifecycle – where it is introduced to the market before it eventually 'dies' out. People who work in this role will want to make that brand as successful as possible while extending its lifecycle as much as they can to get more profits out of the drug.In this role, you may be marketing a brand new health product or you might be…

Health economics is one of those rapidly growing fields that links up business with health care. A health economist has a unique passion for using their knowledge of economics by applying it to a variety of challenges in health and medicine. As the population continues to grow, the demand for quality and cost-effective health care similarly grows, leaving careers in health economics vital to sustaining our health care system
See the latest Health Economics Jobs here Health economics is one of those rapidly growing fields that links up business with health care. A health economist has a unique passion for using their knowledge of economics by applying it to a variety of challenges in health and medicine. As the population continues to grow, the demand for quality and cost-effective health ca…

Medimetrics, recently certified to ISO 13485, has successfully developed the IntelliCap system, specifically designed to target delivery of small molecule drugs and biologics to the GI tract. The technology is capable of achieving controlled release of drugs to specific GI sites in a fast, cost-effective and convenient manner (Shimizu et al., 2008).
Medimetrics, recently certified to ISO 13485, has successfully developed the IntelliCap system, specifically designed to target delivery of small molecule drugs and biologics to the GI tract. The technology is capable of achieving controlled release of drugs to specific GI sites in a fast, cost-effective and convenient manner (Shimizu et al., 2008). This electronic capsule has the added capability of measuring quantitative data such as temperat…

If you want to go further in your clinical research career, the Institute of Clinical Research (ICR) can help. We provide training, analysis and discussion of the issues facing clinical research today, and opportunities for widening your professional network. Join ICR today, and benefit from all these resources straight away, many of them at specially discounted rates.
If you want to go further in your clinical research career, the Institute of Clinical Research (ICR) can help. We provide training, analysis and discussion of the issues facing clinical research today, and opportunities for widening your professional network. Join ICR today, and benefit from all these resources straight away, many of them at specially discounted rates. To become a member today, visit www.icr-global.org/member…