Pharmacy - Articles

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…

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…

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…

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…

Healthcare apps and wearable tech have a long future in the treatment of patients, according to a panel of Primary Care Physicians (PCPs)[i] interviewed as part of a newly launched Ipsos Healthcare study.
“Digital Doctor” is the first study of its kind looking specifically at the attitudes of PCPs to new healthcare technologies. The annual study of PCPs, across the UK, France and Germany, will track trends in this emerging field, look to understand the level of engagement in new healthcare technologies, and identify concerns or barriers to adoption.Cautious optimismThe results show PCPs are wary of new health technologies, but 25% see a role for healthcare apps in the treatment of patients with certain conditions. As many as 72% have already used or recommended at least one form of digital…

Risk Management Opportunity in Health and Social Care
 Individual businesses differ in their level of accountability or, to use a term from the safety management profession, maturity. In an immature industry, we rely on the behaviour, maturity and professionalism of the individual manager. Yet, as the industry grows, it becomes more complex and ever more difficult (impossible) for managers to maintain situational awareness and know what the hell is going on. This is the moment when the industry is ripe for a step change in management control. It cries out for great systems in order to cope, move forward and thrive at the next level.Sadly, the trajectory for change often involves undesirable events that, with hindsight, might have been avoided (such as financial failures, safety failure…

An interactive, intensive, one-day workshop designed to help you master the key skills required to manage and produce high-quality, submission-ready clinical study reports
An interactive, intensive, one-day workshop designed to help you master the key skills required to manage and produce high-quality, submission-ready clinical study reports.introductionThe production of clinical study reports is an essential component of any clinical development programme. One of the keys to a successful submission is the inclusion of documents that are well-written, clear and precise, that are therefore easy to read and understand and intuitive to navigate. "Mastering the essential skills: clinical study reports" is an interactive, intensive, one-day workshop designed to help you master the key skills req…

New dementia care guidance is published
Following the Prime Minister’s 2012 challenge to improve dementia care by 2015, PAS 1365 Code of practice for the recognition of dementia-friendly communities in England has been published by BSI, the UK’s National Standards Body. The guidance has been developed in conjunction with Alzheimer’s Society and the Department of Health. It has had collaborative input from organizations including Age UK, the Dementia Action Alliance (DAA) and Public Health England.There are an estimated 850,000 people living with dementia in the UK with numbers set to rise to over 1 million by 2021, and expected to soar further to over 1.7 million by 2050. Currently two thirds of people with dementia live in the community and 70 per cent of people in care homes have dementia…

Why Pharma CIOs and CMOs need to get along
The pharmaceutical industry is currently going through a period of considerable upheaval. Indeed, as we’ve written recently, it could be suggested that the entire sector is in crisis and in need of fresh ideas. These challenges include the ever-nearing patent cliff and an overall lack of rendering many organisations unable to meet the demands of modern, global markets. One additional issue that hasn’t always initially sprung to mind is the lack of collaboration between Chief Marketing Officers (CMOs) and Chief Information Officers (CIOs); however a recent Accenture study found that solving this particular issue could directly benefit businesses in a number of ways. So with this in mind, what did the survey reveal and how can these two roles work to…

Important Drug Discoveries in Medicine
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Pharmaceutical interviews - preparation is key feature from Apex International
Job interviews can be a daunting experience at the best of times, so it's particularly important in the current climate to ensure you are well-prepared for this stage of recruitment.Preparing for a pharmaceutical interview is in many respects similar to applying for positions in other high-status professions. Punctuality, a confident manner and a professional appearance are essential parts of any successful job interview.It is also important that candidates spend an appropriate amount of time researching and familiarising themselves with both the company and the role for which they are being considered before the day of the interview.Recruitment for permanent pharmaceutical roles is often carried out in different…

PV-10 and checkpoint inhibitor enhance melanoma regression
In mouse models of melanoma adding check point inhibitors to intralesional (IL) PV-10 improved tumour regression and stimulated immune response, reports a study presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting, 6-9 November, National Harbor, Maryland, USA¹.An earlier phase 2 study showed injecting IL PV-10, into the lesions of 80 stage IIIB-IV melanoma patients refractory to a median of six prior interventions, delivered a best overall response rate of 51% and complete response rate of 26%. PV-10, a 10% solution of Rose Bengal taking its name from the dot that signals marriage on the foreheads of women in Bengal, was originally used in liver function studies and to detect eye disease. It has been developed by P…

Patients with stage IIB-IV melanoma who had cutaneous and subcutaneous melanoma lesions injected with PV-10 showed marked differences in progression free survival according to number of lesions injected, reported the latest data from a phase 2 trial presented at the 2014 European Society for Medical Oncology (ESMO) Congress, held Madrid, Spain, 26 to 30 September.
The rationale for PV-10, a 10% solution of Rose Bengal developed first as a dye, is that the agent has a local chemo ablative effect where it enters lysosomes causing local necrosis, and then in some patients a systemic effect believed to be immunologically mediated. Previous studies have demonstrated increased CD8+, CD4+, CD3+ and NKT in peripheral blood within seven days of injection.In the open label phase 2 study 80 patients w…