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Stop reinventing the wheel: why life sciences firms must be smarter about document production
A lack of structured authoring in life sciences has limited companies’ scope to infuse regulatory processes with efficiency. But there’s scope to change that now, says AMPLEXOR’s Romuald Braun. In engineering-based industries, used of structured authoring – routinely populating documents with approved information components - is second nature. By contrast, life sciences has muddled through with simple office-style content tools for generating routine operational and regulatory documents. This has meant that teams have had to start from scratch each time a new or updated document is needed – finding the right data all over again, and assembling it as required. As well as being laborious, this appr…
Practitioner's guide to leveraging salesforce competitive intelligence in the pharmaceutical industry
Benchmarking refers to the comparison of the metrics, processes and practices of a particular business against the others in the industry. Proponents of benchmarking argue that, when performed judiciously, it is one of the best decision-making tools available. It brings an external perspective to the table, triggers sanity checks, eliminates internal biases, reveals blind spots and provides an opportunity to emulate or exceed. The pharma industry, is principally known for innovation, a fact reflected by the significant investment in its R&D function. In a reasonably sized pharma/biotech company with marketed products, sales and marketing typically constitute the largest expense as a…
As regulatory workloads soar, the first step to better resource management is better measurement, says Adrian Leibert, life science and pharma programme manager for regulatory outsourcing at Kinapse
Since it’s hard to manage what you can’t measure, the best way to keep pace with regulatory resourcing is to unambiguously understand what’s involved in complex workloads, says Kinapse’s Adrian Leibert   As budgets have come under pressure and more Regulatory work has been outsourced, firms have faced a growing need to monitor, manage and report on resource consumption and value for money. The default approach has been to do this according to the raw number of documents processed – so if one year 1,000 documents were authored, and the next year the number was 900, there was an expect…
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 pati…
We all know that LinkedIn is a great resource for recruiters, but how can you take advantage of it without an expensive recruiting account? Here's a few ideas:
Use Your LinkedIn Headline By using your LinkedIn Headline as a “quick advert”, anyone who looks at your profile will see what you’re after. For example  “Looking for experienced Regulatory Affairs professionals in London” Post an Image of Your Hot Job You can use an online tool like PicMonkey or Stencil to create an image of your Hot Job (or a generic version) . Keep it simple and clean and come up with a template you can use repeatedly by changing the job title. Then post your image so that it appears on your timeline. Do Some “People” Searches Now that you have the job in your headline and timeline, do some sim…
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 wa…
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, attractiv…
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…
The Current State of ICH E6 Revision 2
In November 2017, one of the EMA’s Inspectors, Sophia Mylona, reiterated the importance of Revision 2 (R2) to the attendees at the 5th Global QA conference in Edinburgh, Scotland. Her message surprised the crowd. Not because ICH E6 (R2) is something new. On the contrary, this revision was finalized in November 2016 and put into effect by the EMA back in June of 2017. The surprise revolved around the EMA’s expectations for ongoing trials. The EMA expects R2 standards to be applied to ongoing trials “to a reasonable and feasible extent, using common sense.” Thus, any Sponsor or CRO running a trial in Europe will need to be R2 compliant. For our Canadian clients, R2 adoption will be mandatory in April of 2018. We are predicting that the United States will…
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 F…
What Questions to ask at the end of an interview
If you've been through the interview and the recruiter says that inevitable question..."Do you have any questions?" - You don't want to be sitting there like a lemon, and mumble "no". That won't win any prizes and certainly won't get you the job. So here are a few ideas.Do you see any gaps in my CV / experience and the job requirements?How long have you worked here?What are the opportunities for career progression?What sort of training do you offer?Who would I report to?Is this a new role, or has someone left (and why!) ? What is the company's future looking like? (ie relocation, takeover / merger, product pipeline etc)Why did YOU decided to choose this company?What are the biggest challenges for someone in this role?Do you think I'll be a go…
The latest CPIA report features analysis and data from the Clinical sector within the pharmaceutical industry for UK, Ireland, Germany, Switzerland, Belgium, Netherlands, and Luxembourg.
The Clinical Professionals group aim to be aware of the latest industry events and news whilst also aspiring to be at the forefront of the latest analytics and reporting. This enables our consultants to provide a concise and quality service for both clients and candidates, whilst helping the industry to evolve as a whole. Consequently, the Clinical Professionals group has collaborated with Vacancysoft to create monthly reports that provide an in-depth analysis of vacancies across various sectors, countries and companies. The latest CPIA report features analysis and data from the Clinical sector within th…
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…
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 Sta…
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,…
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…