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17-Aug-2016
How innovating for emerging markets is set to disrupt the global surgical care industry
The growth of emerging markets is poised to transform the delivery of surgical care around the world by 2030, according to a new report. The emphasis will be on affordable technology for early diagnosis; portable modular equipment for minimally invasive and robotic surgery; and smart systems incorporating low-cost sensors and mobile technology to track clinical outcomes and improve team-based surgery.The report summarises the findings of a workshop held in Boston earlier this year by product design and development firm Cambridge Consultants. It offers unique insight into the future of emerging markets surgical care – as seen through the eyes of industry leaders. And it looks at how these new approaches t…
The drive towards preventative healthcare is placing new focus on food – from the dietary qualities of packaged produce, to the health claims of so-called ‘nutraceuticals’. It has captured the imagination of governments, healthcare providers, the general public, and the life sciences industry. But it has also woken the regulatory giants, who are now drawing up new standards for information and labelling, says Peter Muller of Schlafender Hase
Regulators’ growing interest in food and nutraceuticals (foods with added health benefits) reflects growing government interest in helping consumers to make better dietary choices. This will affect the pharma industry, which wants its share of these adjacent market opportunities. Nutraceuticals in particular offers a new take on preventative healthcare…
Empowering experts, retaining talent
It’s hard enough for pharma organisations to find and keep top regulatory talent in the current climate, so the last thing they can afford is to lose valued skills to a competitor. To reduce their exposure, firms need to automate more of their routine processes, relieving pressure on overstretched employees while giving them a better quality of working life, says Dr. Jutta Hohenhörst of Schlafender HaseEven without the implications of Brexit, these are turbulent times for regulatory teams. Compliance has become a full-time job, and administrative demands are on a permanently upward trajectory.The more rules there are, and the more frequently these change, the greater the risk of something going wrong (with product labelling, for example). Often it is hig…
Balancing openness and privacy: clinical trials
The drive to improve the transparency and collaborative nature of life sciences processes has reached clinical study reports, which must now be opened up for external access. This must happen in line with new EMA guidance on safeguarding subjects’ identities. The associated de-identification process is no small feat, so the temptation for manufacturers is to find a shortcut to delivering this in time for the November deadline. But focusing on clinical study reports in isolation won’t leave companies any better prepared for the next raft of requirements, warns Chris Olinger of d-Wise In this era of openness, where the aim is not just to ensure patient safety but also to improve consumer confidence, there is  growing pressure on life scien…
Compliance - more than just red tape Using regulatory criteria to improve product quality
A growing customer demand for regulatory compliance combined with increased competition amongst manufacturers has made SCADA software a minimum requirement for the pharmaceutical industry. Here, Lee Sullivan, Regional Manager at COPA-DATA UK discusses why today, more than ever before, regulatory compliance is crucial for the pharmaceutical industry.FDA statistics are forcing the industry to identify and implement improvements to its manufacturing processes. In its latest reports, the FDA identified a significant increase in the number of drug shortages reported globally. With 65% of these drug shortage instances directly caused by issues in product quality, it’s clear that if more pharma manufa…
Alexander Mann Solutions
The culture of the pharmaceutical sector reveres talent and experience above all else – and with good reason. However, at a time when cuts in government spending, patent cliffs, significant talent shortages, and shifts in business focus between therapeutic areas are all threatening the stability of the sector, how can organisations best manage their workforces to ensure future success and profitability?As a historically cash-rich industry, pharma has long had the freedom to hire at will, often from within, but bold new business models coupled with drives towards efficiency are rapidly changing talent needs. The traditional approach to managing skill shortages has been to draft in expertise with little consideration to cost. While this strategy has worked well in t…
On-tap analytics: the key to getting ahead in 2016
Whether it’s meeting new regulatory imperatives or the need to position products differently, there are a wealth of challenges facing life sciences companies - and the key to overcoming most of them is the intelligence locked inside everyday data, says Elvis Paćelat, VP Compliance Solutions at AMPLEXOR Life SciencesThe root of the problem seems to be that information capture, management and discovery projects in the industry have evolved according to specific individual requirements; they have not be aligned with a broader vision for business transformation. But the hope is that this will change in 2016, because of intensifying competitive pressures, the need for new business models, and the requirement to be much more transparent with cust…
As a recruiter it' up to you to weed out the bad candidates from the pile, so what strategies do you use? - Here are a few types of candidate who are best avoided...
The Evasive Candidate You’ve more than likely come across this sort of candidate. Ask a straight-forward question, such as why they changed job/career path, and they’re unable to give you a straight answer. There might be valid reasons, but it might equally be because they’re hiding something, are unable to articulate or are uncomfortable being put on the spot. The Job Hopper This sort of candidate is easily spotted. Just look at their CV. Somebody who repeatedly changes job should be viewed with a degree of suspicion. It might be because they get bored easily; they are hard to work with; or they are so career driven that they…
Tackling a credibility crisis: A watchout for Indian Pharmaceuticals
By Dev K. Ramchandani, Director & Head of India, Hitachi Consulting; and Vivek Chaturvedi, Vice President of EMEA, Hitachi Consulting The Indian pharmaceutical industry has been cited as a “flagship” sector by Prime Minister Modi’s government. It has one of the highest number of UDFDA, UKMHRA, WHO-GMP1 approved manufacturing facilities for medical ingredients and formulations outside of the US and Europe. These facilities are responsible for a quarter of all medicines consumed in the UK and they make nearly 40% of generic drugs and over-the-counter products sold in the US2 as well as many drugs and vaccines used by global aid agencies for health programmes. On paper, the industry is blossoming, so why in reality, is…
The Science of Employee Engagement
A third of employees in the life science sector feel disengaged at work and a salary increase is not the solution. According to a recent survey carried out by leading international staffing agency – ProClinical – a third of staff working within the life sciences industry are disengaged in their jobs and at risk of leaving in the next 12 months. The survey of more than 1000 individuals employed in the life sciences industry, including pharmaceutical, medical device, biotechnology and contract research organisations in Europe, the USA and Asia Pacific, revealed that disengaged employees are twice as likely to leave and that it takes more than just a good salary to keep them motivated and loyal to their employers. The participants were asked a series of…
Smarter steps to compliance: The future of regulatory compliance in the pharmaceutical industry
The pharmaceutical industry today operates in one of the world’s most heavily regulated environments. Over the past few years, the industry has experienced significant regulatory change and looking to the future, the strict nature of the industry doesn’t appear to be slacking. The repercussions of failing to comply with industry standards can be detrimental for pharmaceutical manufacturers. It’s no secret that the integrity and reputation of pharmaceutical brands is integral to their success. As a result, even the smallest failure can be irreversibly damaging. With industry standards surrounding crucial elements like product integrity, energy efficiency, health and safety and product testing, th…
Until life sciences companies are able to manage product lifecycle information holistically, their ability to seize new market opportunities will be limited, warns Mark Evenepoel, Group CEO at AMPLEXOR Life Sciences
Until life sciences companies are able to manage product lifecycle information holistically, their ability to seize new market opportunities will be limited, warns Mark Evenepoel, Group CEO at AMPLEXOR Life Sciences In 2016, the life sciences industry faces increasingly complex regulatory challenges and operational risks: the result of technology advances, clinician and patient expectations, and a globally-connected healthcare market. But unless organisations tackle the association product data management challenges holistically, they could be running up high levels of expense…
2016: A critical year for compliance—and combative manoeuvres
As 2015 draws to a close—and with a number of important regulatory deadlines set to converge during the year ahead, data preparation efforts across the life sciences industry are reaching a peak. But what benefit do companies expect for their pains? wonders ProductLife Group’s Chief Operating Officer, John Farrell Data centralisation and harmonisation efforts are the preoccupations of regulatory teams across the life sciences industry because regulatory demands around product and process transparency have intensified. Activity reached a peak in 2015 as companies looked down the barrels of approaching deadlines, by which points a whole range of data must have been captured, managed, submitted, and updated in particular ways. Life…
As Biomedical companies from around the world take stock after attending the industry flagship MEDICA show in Duesseldorf, many will have sown the seeds of new partnerships, client relationships, and international research collaborations. For some, their company growth may be pointing to a rise in cross-border business and a need to consider an overseas presence – perhaps for the first time.
~~As Biomedical companies from around the world take stock after attending the industry flagship MEDICA show in Duesseldorf, many will have sown the seeds of new partnerships, client relationships, and international research collaborations. For some, their company growth may be pointing to a rise in cross-border business and a need to consider an overseas presence – perhaps for the first time. Connectin…
What can life sciences organisations learn from the investment banking sector?
With the most recent public debate on drug pricing, government healthcare budgets under scrutiny, ever more rigorous compliance and transparency demands, and problematic patent cliffs, is the life sciences sector heading for a modern day crisis?  2020 will see a surge in healthcare demand precipitated by an aging population with chronic care needs, income growth in emerging markets, and expansion in health insurance globally, with the industry having to shift to a more efficient management of costs as pressure from payers, reimbursement challenges and development costs increase. Most importantly there will also be a growing shortage of highly skilled and specialised talent in the industry. All of this is&nbs…
Modern Technology in Medicine: How it's changing the future of treatment
Technology is expanding on an ever-changing and regular basis. It has helped to achieve multiple breakthroughs in science and medicine, providing our society with new means of treatment that often lead to potential cures for various illnesses and diseases etc. Technology helps us to gather essential information, research and treatments that have changed and will continue to change the future of medical treatment. Improved Patient Care Technology does not just refer to the digital aspects of the term. It also refers to the practical and physical advances in modern technology such as the various medical supplies available on Brosch Direct. IT has also had a great advantage with regards to patient care as hospital staff…
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PharmiWeb.com Training Courses with Vincent Lody
 Recruiter/Resourer Training CoursePharmiWeb is pleased to announce that we are offering places on our new recruiter training course to be held at our Bracknell  offices This is on a first-come-first-served basis, so if you’re interested...Contact Kelly Tipper to request info about the courses or reserve a spotPharmiWeb Promotional Recruiter/Resourcer TrainingSuitable for any recruiter/resourcer in the industry with hints and tips on key elements of recruitment as well as information on how to be more successful.Course content Big Pharma RecruitmentIssues and StrategyRecruitment IssuesWhat’s stopping you achieving your targetsUK RecruitmentMarket overviewRecruitmentBeing a recruitment consultantUSP’sWhy youClient business…
Phases of Clinical Trials
A clinical trial is a research study involving patients that can be used as a way of measuring effectiveness and safety as well as comparing different treatments or the level of side effects between different drugs. Clinical trials are also used to test new methods of screening, diagnostic tests etc. For a drug to enter everyday use it must first pass a series of clinical trials and then obtain approval from the appropriate regulatory agencies (EMA for European Union and FDA for USA).Clinical trials involving new drugs are commonly classified into three main phases (1, 2 and 3) but there is also a preclinical phase and a fourth phase. The phases of clinical drug research are the steps in which scientists do experiments in an attempt to find enough evidenc…
Is M&A set to replace R&D in Pharma?
As has been previously reported, the pharmaceutical industry looks set to benefit from a strong 2015 thanks to an increase in the price of drugs and an increase in the number of sales. However, more recent reports have also emerged detailing how the internal structure of pharmaceutical companies are also set to change dramatically, alongside the dramatic increase in M&A activity in the sector.According to the VCCircle website, M&A activity in the pharmaceutical sector in the US surpassed $59.3 billion by March of this year, and overall global pharma deals announced from January to August of 2015 reached $284 billion. Mega-mergers across the globe are also taking place, with Shire hoping to acquire Baxalta, Mylan hoping to acquire Perrigo but faci…