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Part four of a four part series
In the final part of this blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunity in the uppermost reaches of North America Canada in close-upAs a member of the International Council for Harmonisation, Canada takes a regulatory approach familiar to most global companies. The approach is similar to Europe’s, although Health Canada has implemented certain country-specific regulations.Canada requires that a physical entity (directly owned or otherwise) be in the country for a drug establishment licence. Companies that have experience with the European eCTD or even US submission requirements should find preparing an eCTD for Canad…
Part One of a four part series
In a new blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunityAs global opportunities expand and barriers to market entry diminish in the form of increasingly consistent submissions requirements, we can expect to see more pharmaceutical organisations expand their international reach in and beyond 2018.There are few geographic markets more strategically attractive than the European region of Benelux.Market scopeThe Benelux region (Belgium, the Netherlands, and Luxembourg) is an important European market for life sciences, not least because Brussels is home to the administrative HQ of the European Union. At the heart of Benelux,…
Part three of a four part series
In a new blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunitySouth Africa under the spotlightAs the gateway to the African continent, South Africa is an important pharmaceutical market, though its regulatory regime remains in a state of flux.In June 2017, the government introduced the Medicines and Related Substances Amendment Act and is establishing the new South African Health Products Regulatory Authority (SAHPRA) to oversee medical devices and medicinal products. SAHPRA will replace the Medicines Control Council, but its full scope will be implemented over two years.These are the latest in a series of steps to shake up…
Collaborative eco-systems are needed for the UK’s life sciences industry to flourish
Britain’s £64bn life sciences sector is in line for a boost. In August, the Government pledged funding to areas such as R&D, manufacturing and skills, as well as facilitating better relationships between drug companies, academia and the NHS, as part of its plan to reinvigorate its industrial strategy. Funding started to trickle through for some areas in October, with further investment planned before the end of this parliament. This move has been welcomed, by industry leaders such as GlaxoSmithKline, which has said better collaboration is much needed if Britain is to remain an attractive location for drug makers. Key to delivering better collaboration across life sciences stakeholders will be br…
The key objective when posting a job advert, is to maximise the application rates from suitable candidates. So take a minute to review this checklist.
Firstly, when creating a job advert, please, please, PLEASE, don't simply cut and paste the job description. It's plain lazy, and can often put off candidates with a dry list of what they will be doing and the skills they need. Job Title Is the Job Title obvious? Make sure you're not using any job titles that are specific to your organisation. Have you included variations of the Job Title where relevant? (eg "Clinical Research Associate / CRA") Don't include any superlatives (eg "excellent opportunity") - these just make it harder to read the job title, and actually don't add anything. Don't include the location unles…
These days, we all have to be careful about discrimination in recruitment. It’s also worth remembering that you might be breaking the law if any discrimination happens during their recruitment process, even if you use a recruitment agency.
The key areas to avoid in your job adverts are: Age  discrimination Disability discrimination Gender discrimination Race or religion discrimination Firstly and most obviously, you must not include anything in your job advert that directly says you’ll discriminate against anyone. For example, you’re not allowed to state you can’t or won’t employ workers with a disability, of a certain age, gender etc. Be careful using phrases like ‘highly experienced’ or ‘recent graduate’ unless these are actual requirements of the job. Otherw…
How to get the most out of your PharmiWeb.com banner
If you are using banners, these few tips can be used to help you get the most out of your Banner Advertising on PharmiWeb.com or anywhere else for that matter. Just increasing your Click Through Rate (CTR) by a few percent might make a huge difference to the success of your campaign. Pose Questions Try questions like “Did you know…” “Have you seen…” – the visitor who subconsciously reads the question will be enticed to take action. Some research shows that this can raise click through significantly. Bright Colours Bright colours can attract the eye, particularly where you’re competing with other banners and distractions. If you’re not constrained by branding, try Blue, Green or Yellow. White and Black are less effective. Ma…
AI: The next frontier of innovation in life sciences
ProductLife Group’s Marco Anelli looks at the potential of artificial intelligence to change the way life sciences organisations operate. From discovery and development and throughout the entire product life cycle, artificial intelligence (AI) has already shaken up the life sciences industry by way of innovations such as AI-enabled drugs expected to be brought to market in the near future. But AI has the potential to go beyond that. Given the plethora of data all across the life sciences value chain, the ability to gather, manage, and effectively use intelligence from that data has posed a challenge. AI offers the chance to exploit the data in both structured and unstructured forms. Data that previously was hard to access or too diffic…
Master data management and addressing the forthcoming ISO IDMP standards
AMPLEXOR’s Sonia Monahan looks at what is involved in practice and how can life sciences firms ensure the investment pays off ISO IDMP compliance is more than just another regulatory hurdle for life sciences firms to straddle. It also promotes the kind of structure and discipline needed if organisations want to break new ground and take their businesses forward. It all begins with data though, and with assumptions about its quality, completeness, and reliability as an accurate record of operations.As EMA’s IDMP requirements near finalisation, the scale of the standards’ impact on managing regulatory data becomes more apparent. The transition from the current xEVMPD submission requirement to the more extensive and round…
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5 Reasons Why Pharmaceutical Companies Should Use Accredited Calibration Labs
Instruments in pharmaceutical companies should be calibrated so that their performance and results can be trusted. There should be no shred of doubt if the equipment has been calibrated as per the required standards or not. This is why you must use an accredited calibration lab for your equipment calibration.Pharmaceutical companies cannot afford to be lenient about calibration or compromise on the quality. Any kind of inaccurate measurement can cause a breach of process, product recall or potential fines from the FDA. Moreover, the user’s life could be put at risk. Even if there is a small variance, you can be subjected to large cost over-runs and a dip in the quality. To avoid such issues, you must use calibrati…
AMPLEXOR’s Romuald Braun looks at best practice in labelling management and master data management
For some life sciences firms, product labelling is treated as a distinct, manually-driven process. This is a major error and can leave them vulnerable to risk, such as costly product recalls, and inefficiency. To reduce this risk, associated processes need to be systematically managed, using automation - so that the latest compliant wording, symbols and other criteria are used consistently and reliably, and that checks and controls aren’t reliant on human proofing alone.While many organisations still rely too much on manual processes, intensifying regulatory requirements and the evolution towards IDMP means that they are looking again at their processes and systems for managing content. The mo…
The use of drones in the emergency services
Care in the air - it’s what has already saved thousands of lives through the Air Ambulance service and now drones are having their moment. According to Wired, police across Devon and Cornwall have started to introduce a 24-hour drone unit: 'The drones will largely be used for surveillance of crime scenes and to help in the search for missing people, and it will be the first 24-hour drone unit in the UK, operating out of nine police stations,' stated the article.It’s vital to the Devonshire and Cornwall police that the drones protect people without being obstructive of their privacy. So far, they have been well received as a good alternative to police trying to make their way across tricky landscapes by vehicles. Due to cuts to police budgets, it’s…
Neo4j’s Emil Eifrem takes a look at how life science researchers can use graph databases to get granular insight from big data and make real advances in research
Big data, defined as large complex data sets, has the potential to throw light onto every link in the life sciences value chain, which is why data mining has become so important to researchers – but having the right technology is key to its success. Traditional database tools, namely SQL and relational database technology, find the volume as well as the unstructured nature of these complex datasets extremely difficult to work with. Why? Because they model the world as a set of tables and columns, peppered with complex joins as the data becomes more inter-connected. Data queries are technically difficult and notoriously expensive…
Competitive intelligence gained via primary research is one of the frequently utilised decision-making aids. Most competitive intelligence firms claim to provide actionable insights. However, truly actionable insights come from credible sources of intelligence. Paying attention to the sources and respondents is vital for leveraging intelligence and its subsequent use in decision making.
The insights gathered from competitive intelligence (CI) engagements are intelligence not data, thus CI based insights are not amenable to most quantitative methods. Consequently, it is crucial to be vigilant about the quality of intelligence. In one recent survey, we found that over 80% of the intelligence comes from KOLs (Key Opinion Leader) or their associates. Further analysis revealed that nearly 75% of…
The life sciences sector is both fascinating and diverse focusing on a wide range of subjects including biology, botany, zoology, microbiology and biochemistry. There are many different job roles available within the field too, with specialist recruiters such as NESGT filling skilled positions, but is the life sciences industry one of the best industries to be involved with?
The life sciences sector is both fascinating and diverse focusing on a wide range of subjects including biology, botany, zoology, microbiology and biochemistry. There are many different job roles available within the field too, with specialist recruiters such as NESGT filling skilled positions, but is the life sciences industry one of the best industries to be involved with?Productivity double that of national averageW…
The UK currently accounts for the country with the highest volume of Contract Research Organization (CRO) vacancies in Europe. In this CRO report, our partners Vacancysoft have based the data from a total of 15,702 vacancies in the period between May 2015 and April 2017.
Clinical Professionals Industry Analytical Reports regularly review the life science industry, giving unique insight into the current trends. At Clinical Professionals we aim to be aware of the latest industry events and news whilst also aspiring to be at the forefront of the latest analysis and reporting. This enables us to provide concise and top notch quality service for both our clients and our candidates. Whilst helping the industry to evolve and progress as a whole. Consequently Clinical Professionals are ha…
Competitive intelligence gained via primary research is one of the frequently utilised decision-making aids. Most competitive intelligence firms claim to provide actionable insights. However, truly actionable insights come from credible sources of intelligence. Paying attention to the sources and respondents is vital for leveraging intelligence and its subsequent use in decision making.
The insights gathered from competitive intelligence (CI) engagements are intelligence not data, thus CI based insights are not amenable to most quantitative methods. Consequently, it is crucial to be vigilant about the quality of intelligence. In one recent survey, we found that over 80% of the intelligence come from KOLs (Key Opinion Leader) or their associates. Further analysis revealed that nearly 75% of…
From slow start to rapid digitization: How IoT will transform the life sciences and healthcare supply chain
By Scott Allison, President, Life Sciences & Healthcare Sector, DHL Customer Solutions & Innovation The life sciences and healthcare industry as a whole has been slow to digitize. But things are starting to change now, fast-tracked by the growing phenomenon of the Internet of Things (IoT).  We are told that by 2020, more than 50 billion objects will be connected to the Internet (Cisco Consulting). So far, an absence of agreed industry standards and some genuine security concerns have restricted IoT innovation. But today there is clear evidence of an upswing in industry-specific applications, and it is only a matter of time before pharmaceutical and medical device comp…
Docs Global announces a new division in Biometrics, recruiting a number of data managers and statistical Programmers.
Docs Global announces a new division in Biometrics, recruiting a number of data managers and statistical Programmers. DOCS is creating a new division in biometrics, recruiting a number of data managers and statistical programmers on different seniority levels, for a global sponsor. This will be generating a large number of new positions for Statistical programmers across Europe. These positions offer the opportunity to work from home, with an award winning international team. The new division will be working with one of the biggest pharmaceutical companies across the globe, operating in various therapeutic areas such as oncology, respiratory and inflammation, cardiology,…