Pharmaco - Articles

The pressure of public scrutiny – Kinapse on whether the EMA’s demands for Plain Language Summaries for clinical studies, that are understandable by anyone, tip sponsors over the edge?
From 2019, to comply with requirements for greater transparency around clinical research, encapsulated in the EU Clinical Trials Regulation 536/2014 (Article 37), life sciences firms will have to prepare plain language summaries (PLSs) of their clinical studies that can be understood by lay readers as well as clinical experts. For trial sponsors, this is a significant undertaking. Challenges and concerns include:          Clinical teams and medical writing specialists struggling to understand what to include/leave out and how to pitch the summaries so that patients’…

Practical tips on how your pharma brand can confidently include social media in the digital marketing mix, without the risk of fines for breaching adverse event reporting regulations.
“Health is the greatest gift, contentment the greatest wealth, faithfulness the best relationship.”– Buddha Being healthy isn’t a new trend but it seems more of us than ever before are striving to be healthier as we reach for this ‘greatest gift’. We’re also taking more prescribed treatments than ever before. According to NHS Digital, a total of 1.1 million prescriptions were dispensed last year - a rise of 47 per cent in a decade. Achieving ‘contentment’ meanwhile, appears to come from knowing as much as possible about our health – making the internet a key source of information for patients. Rather than wait…

Every Hiring Manager Should Read This
A few simple points that every hiring manager should keep in mind!Talent Does Not Grow on Trees – Every candidate has choicesHurry Up! – Each candidate WILL be talking to multiple companies, so if you’re not quick off the mark, you’ll miss the best candidates! Job Scope Creep – If you’re replacing someone who’s been in the role for 10 years, locating a candidate with the same skills is going to be hard. Break down the job in to multiple roles.Compensation – It’s not determined by your 10 year old pay & benefits structure, its determined by the market – Otherwise you’ll find attracting talent will be an uphill struggle.Skills Shortage – Don’t bury your head in the sand, there IS a shortage of good candidates, so employer branding programs, attractive…

The 32nd annual PM Society Awards, announced at the Grosvenor House on 2nd February saw a record number of Golds won by a single agency – VCCP Health. They scooped an amazing 10 Golds plus 3 Silvers and 3 Bronze awards. Other successful agencies were Havas Lynx with two Golds as well as five Silvers, and Lime taking two Golds. CDM London, H4B Manchester, Life, McCann Health, Solaris Health & Watchable and vivacity each took one Gold Award.
VCCP Health sweeps the board with a record 10 GoldsLEO and Teva are the top pharma companies recognisedThe 32nd annual PM Society Awards, announced at the Grosvenor House on 2nd February saw a record number of Golds won by a single agency – VCCP Health. They scooped an amazing 10 Golds plus 3 Silvers and 3 Bronze awards. Other successful agencies were H…

Lifesaving labelling for hospital pharmacists
According to NHS National Statistics, the total number of items dispensed from Britain’s pharmacies rose from 752 million in 2006, to a colossal 1,104 million in 2016. With an ever-increasing number of prescriptions dispensed each year, Darren Pittock, Sales Representative at pharmaceutical packaging supplier, Valley Northern, explains the importance of listening to the packaging requests of those on the front line — the pharmacists.  The NHS report states that the average number of prescription items per head of the population is 20 per year. This may seem like a modest figure, but it amounts to 2.7 million prescription medications every single day. For pharmacists, ensuring this immense number of prescriptions are dispensed accurately and…

2018 Editorial Calendar
January   2017 Looking back 2017 drug launches summary Dermatology Job Focus: Clinical Research Associate (CRA) February   Big Pharma Respiratory Job Focus: Biostatistics March   UK Clinical Research & Brexit Gastroenterology Job Focus: Medical Writing April   Cardiovascular Stem Cells Job Focus: Medical Science Liaison (MSL) May   Diabetes Digital Marketing in Pharma Job Focus: Sales / Business Development June   Infectious diseases UK Biotech Job Focus: QA / QC July   Vaccines Training Focus Job Focus: Regulatory Affairs August   Inflammation Medical Devices Job Focus: Study manager …

Are you current and up to date with your training?
ICH-GCP Training including E6R2 addendum ICH-GCP states that it is the sponsors’ discretion as to how often you should be taking GCP training, several guidelines suggest every two years. However, in recent audit findings the Regulatory Authorities have found significant compliance issues in clinical trials due to insufficient training. If you haven’t taken GCP training since the E6R2 update was implemented in June 2017, then you will have to familiarise yourself with the new changes to meet GCP requirements. Good news is you don’t have to fully re sit GCP you can just complete training on the update with proof that you have done so, along with your up to date GCP certificate. Depending on how long ago you took your GCP training it may w…

Part two 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 opportunity Evaluating the Baltic region Since joining the European Union, Lithuania, Latvia, and Estonia have adopted relevant European Union legislation; and companies preparing local submissions must have authorisation from the local authority (each country has its own) or from the European Medicines Agency (EMA) depending on the type of registration. The respective national authorities cooperate readily, and they liaise closely with EMA, the European Directorate for the Quality of Medicines & HealthCare, and other international organisations. In Latvia, the State Ag…

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 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 Canada…

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 bringi…

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 unless it's s…

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. Otherwise you may…

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. Make it Clea…

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 difficu…

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…

This Salary Survey is jointly run by SciPro and PharmiWeb.
PharmiWeb have teamed up with SciPro to run the 2017 Salary & Trends Survey. By taking part in this survey. Take Part Today!

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…