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Data harmonisation in a fragmenting market: Brexit & IDMP
How will Brexit and other challenges to the status quo affect plans to raise life sciences standards across Europe and internationally, asks Schlafender Hase’s Dr. Jutta Hohenhörst.Discord rather than harmony seems to prevail internationally at the moment, which seems at odds with plans to collectively raise industry standards and safety across the world. Brexit negotiations risk destabilising the EU, and markets from the US to Asia are becoming increasingly unpredictable, whatever the intentions of global standards promoters. For now it is hard to know how global pharma regulatory requirements might be affected by all of the current political instability.No one would argue that the pharma industry and the public at large have much t…
Working in the healthcare industry: How it’s evolved
When the NHS was founded back in July 1948, the dream was that Britain could provide healthcare for everyone at no cost to the patient. This belief is still at the forefront of the NHS with the central principles that the health service will be available to all and financed entirely from taxation. This model has worked well, but shortages of healthcare staff and increasing numbers of people who require medical care going up, mean the healthcare system often receives negative press. The Royal College of Nursing says that England is in need of at least 20,000 extra nursing staff this year, meaning at present there are 8.8 nurses per 1000 people across the UK. These figures are slightly lower for midwives, general practitioners and docto…
Unless companies improve their use and manage data, they can’t hope to become more flexible, innovative or efficient, warns AMPLEXOR’S senior life sciences consultant, Siniša Belina.
Unless companies improve their use and manage data, they can’t hope to become more flexible, innovative or efficient, warns AMPLEXOR’S senior life sciences consultant, Siniša Belina. When markets as conservative and compliance oriented as banking and healthcare are being disrupted, it stands to reason that life sciences cannot afford to rest on its laurels. Whatever red tape it is shackled by, it too must heed the call to become more agile and innovative – able to respond to changing market demands. But there is a major sticking point: data. In the industries being disrupted, this has provided the key to…
If the life sciences industry has to raise its game in pharmacovigilance, it may as well make it pay—especially if new diligence turns up product safety as a potential market differentiator, says Cheryl Key, head of PV platform services at ProductLife Group.

If the life sciences industry has to raise its game in pharmacovigilance, it may as well make it pay—especially if new diligence turns up product safety as a potential market differentiator, says Cheryl Key, head of PV platform services at ProductLife Group.



To many pharma firms, the call to innovate means giving the go-ahead to ambitious new development projects or becoming more acquisitive. Yet it could be that a company’s commitment to safety and a company’s ability to demonstrate its superiority already offer an edge the company …


Excelling in biosimilars requires robust knowledge of the landscape and monitoring of the evolving market. Apart from the usual competitive intelligence such as competitors' activities, timelines, differentiation strategies, manufacturing capabilities, sales and marketing plans etc., factoring-in overarching holistic perspective allows one to make strategically aligned and robust decisions.
Myriad of economic and patients’ benefits arguments could be made for making the widespread use of biosimilars. At a macro level, the pharma industry, in the context of biologics drugs is divided into novel and biosimilars makers. However, there are several novel companies that seek to bring biosimilars to market. The rationale for such a strategy is justified by the existence of synergy. The company mig…
Attendance Allowance: Could you Be Claiming?
Do you have care or disability needs? Well, if so, you’ll be aware that having a disability comes at a cost. Paying for carers or any form of assistance can be expensive, but the good news is that there are many benefits available to help you manage the extra cost of having a disability or illness. Many of these benefits aren’t affected by the amount of income you earn, or the savings you have, and that’s true for attendance allowance too.But what is attendance allowance, and could you be entitled to it? Read on to find out...What is attendance allowance? Attendance allowance is a sum of money that’s available to people over 65 years old who need help with personal care. ‘Personal care’ means help with washing, dressing or eating for instance, a…
Stuart Britton provides an SEC Recruitment perspective on what the business has seen from pharmaceutical industry employers since the Brexit vote.
Stuart Britton, CEO of SEC Recruitment, provides a pharmaceutical recruiter's perspective on what SEC Recruitment has seen in the industry since the decision to leave the UK was made by the British public. When the announcement came through on 24th June 2016 that the UK public had voted to leave the European Union, my first reaction was to think of the people we have within SEC. We’re a multi-cultural business, speaking over 20 different languages and I knew that there would be some anxiety about what the future holds for individuals. So my immediate response was to communicate with the SEC team and tell them that whilst there would be a lot of…
From the development of new drugs to the innovation of beyond-the-pill services and cutting-edge technology, the pharmaceutical industry has been successful in expanding its horizons in order to meet the demands of its consumers and cater to the unique needs of several patients around the globe.
From the development of new drugs to the innovation of beyond-the-pill services and cutting-edge technology, the pharmaceutical industry has been successful in expanding its horizons in order to meet the demands of its consumers and cater to the unique needs of several patients around the globe. These advancements in the field of pharmacy have significantly reshaped the current health care landscape, thereby bringing noteworthy benefits to its stakeholders. All of which are influenced by certain fa…
Life sciences cannot escape the call to transform itself as other industries have had to, warns Elvis Pacelat, Vice-President of Compliance Management at AMPLEXOR
Industries from retail to financial services have long accepted the need to digitally transform their operations. It paves the way for step changes in how brands operate, how they engage and get closer to customers, how they build market feedback into development cycles, how they drive new and repeat business, and how they identify and address new market opportunities.All of these challenges exist in the pharma industry too, so it seems surprising that companies here haven’t embraced the trend more enthusiastically.One of the biggest issues life sciences organisations grapple with is data, and visibility across processes. Commonly…
Even though regulatory requirements are already intensifying, data transformation plans in 2017 must extend beyond basic compliance if organisations want to be able to successfully navigate even bigger challenges in the life sciences market, warns Adam Sherlock, CEO of ProductLife Group.
Leaving aside intensified regulatory scrutiny, life sciences organisations still face a host of challenges as 2016 gives way to 2017. Globalisation, market consolidation, and calls for faster innovation and transformation are threatening existing business models and demanding that organisations begin to respond differently. Therefore, to survive and prosper, companies have to be breaking new ground by, for instance, exploring the impacts of looming trends towards preventive, collaborative health care, as we…
Visualising the Future
Modern manufacturing is an ecosystem of interconnected software and hardware that helps refineries, chemical and petrochemical companies optimise plants and achieve operational excellence. As businesses generate vast amounts of data, efficient decision support solutions are needed to make sense of vital information and ensure operations can adapt quickly to dynamic conditions.Today the terms, Industry 4.0 and the Internet of Things (IoT) are widely discussed across the engineering and manufacturing space, including ‘cloud’, ‘big data’. They all have a place to radically automate manufacturing, but they need to be clearly understood and positioned in context with the manufacturer’s operational and commercial objectives.This article aims to de-mystify buzz-terms that c…
This November 9th 2016, the entire world awoke to the “Supremacy of Presidential Entrepreneurialism.” After a couple of hundred years and the first time in US history, the White House now will be occupied by a non-politician and a world-class entrepreneur, President Elect Donald Trump.
This earth shattering event is a powerful wake up call to all the political leaders of the world; many of whom are already afraid of losing their own next election.  There is a fear of draining of swamps; structured bureaucracies and layered incompetencies are now desperately trying to come up with brand new prosperity plans. Trumpization of America, the strategic blue print of Trump’s election victory game plan is now available as a working guide and a mandatory curriculum for the decimated senior poli…
All too frequently, pharmaceutical companies lack objectivity when reviewing brands. This leaves opportunities 'on the table' and weaknesses unaddressed. An external, objective, quantitative assessment of brands enables companies to focus their efforts on the areas that will yield the greatest growth.
Pharmaceutical companies spend considerable sums on marketing to drive growth of their brands. Few, however, take time to thoroughly understand the strengths and weaknesses of their approach. As channels to market become more complex, and pricing and access challenges impede product uptake, excellent marketing is more important than ever for commercial success. Companies must therefore critically challenge their marketing plans and apply a level of rigour to brand reviews that is similar to t…
Outsourced Billing is an ideal solution for medical practitioners who do not want to engross themselves in the process of hiring and training a separate billing department altogether. What they can do with utmost ease is to outsource their billing functions to a billing company who will then handle all the aspects themselves. A team of well-trained staff is generally hired by medical billing companies who are completely well-equipped to handle the ins and outs of medical billing.
The way medical practices manage their operations is rapidly changing due to the evolution of modern technologies, regulations by the government, financial boundaries and patient empowerment. This has led practitioners to decide from the various methods they can garner revenues and cut costs without compromising o…
Are you wondering why your recruitment job adverts don’t seem to work anymore and do you want to start doing something about it? Your candidates have changed.

The prevalence of the internet and modern marketing methods means that your candidates have changed. They are more marketing savvy and are bored by seeing the same old type of demanding recruitment ads they’ve seen for years. Ads that aren’t targeted well and don’t talk to them in the right tone. Ads that don’t grab their attention and look tediously similar with a traditional type of layout – Job Description, Requirements, bullets, more bullets …(that’s if it isn’t all in one hard to digest paragraph!)


Candidates are consumers now and are used to being marketed to, preferably in a sophisticated and intelligent way.

Highl…





Why a meaningful brand is a pharma’s greatest asset
Pharmaceutical companies are under increasing pressure to deliver safe, efficacious and cost-effective drugs, while continuing to be innovative, compliant and profitable.Sustaining competitive advantage has never been more difficult, and businesses are struggling to deliver revenue and growth: Pfizer’s revenues have decreased 28% since 2012, and AstraZeneca’s by 26%. One powerful way companies can safeguard against diminishing shareholder value and returns is to invest in building strong brand equity.With physicians no longer the sole influencers in prescribing and drug purchase decisions; and patients having more access to information about conditions and treatment options than ever before, there is an expanding variety of forces shapin…
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 Hase

Even 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 sci…