In our last blog, we discussed the need for transparency and visibility throughout the labelling process. Reducing the risk of product recalls and non-compliance being the goal. Most would agree that given a clear mandate plus an appropriate level of investment, this can be achieved. Not always easy, but certainly possible. Introducing the required cultural and organisational changes can be a different subject altogether! But what if part of your labelling processes are outsourced either because you’d prefer not to have the overhead or, like much of the life sciences industry, your supply chain spans many CMOs (Contract Manufacturing Organisations)?

Now let’s add some new legislation into the mix just for fun. If you’re a pharma manufacturer, meeting the DSCSA (Drug Supply Chain Security Act) and FMD (Falsified Medicines Directive) requirements for product and package level serialisation is probably going to be at the forefront of your mind right now. If your business is med devices, then it’s likely to be maintaining integrity of UDIs throughout the supply chain and the task of getting your labelling content ‘fit for purpose’ ahead of upload to either the GUDID or EUDAMED (or possibly both) that will be grabbing mindshare.

Before we go any further, let’s look at current supply chain trends across the life sciences industry. According to a survey carried out by NICE Insight in 2016, 69% of pharma and biotech companies expected to increase their use of CMOs going forward – business drivers being to increase agility whilst reducing costs. Gaining rapid entry into emerging markets, portfolio transformation and new partnerships and alliances are contributing factors to this increasing trend. The flip side of this being the risk of non-compliance from introducing multiple potential points of failure

So how do you maintain the integrity and accuracy of your labelling content when your global supply chain may include tens, if not hundreds of affiliates sitting between you and your end customer? How do you also validate that what your partners print on the label aligns with content submitted as part of the regulatory approvals process, including that which is required to satisfy local HA’s?

This is where adopting a cloud based labelling and artwork management solution helps to remove the barriers and disconnects that can often occur across highly fragmented supply chains. Implementation can be quick and easy and new partners can be onboarded with minimal integration effort. Suddenly, the headaches of trying to exchange and align both static and variable labelling content across 3rd party systems and processes is removed as everyone and everything is connected. Content is all held in one place – safely and securely. Every partner can be become a user of the solution and with appropriate permissions, users can review, edit or approve content. Better than this, corporate oversight becomes a given ensuring management by truth and not perception

So much for managing static content. How about the challenge of ensuring alignment of serialisation and UDI content across highly distributed supply chains. How do you also ensure integrity of variable data at print run time with the inevitable disruptions caused by manufacturing downtime and labels that need to be re-printed for quality purposes? Well, here again having ‘variable’ (i.e. print run time) as well as ‘static’ content captured in one single place makes it easy to recover from such situations without risking duplication or inconsistencies.

In our next blog, we’ll talk more about the specifics of capturing and managing variable run time data and how this might work in practice. In the meantime, please feel free to download our recent white paper ‘Connecting the Dots Across the Labelling Life Cycle’ for more insight.

Last week’s event and conference provided a great opportunity for those engaged in the manufacturing segment of the pharma industry to come together and share best practice. It was good for us to be there too. The opportunity to listen to what others are saying across the industry keeps us here at Kallik appraised of what’s foremost in the minds of our customers.

It wasn’t surprising that regulatory related topics featured strongly in discussions at what was an interesting and informative event last week. Both the impact of Brexit and Serialisation are clearly hot topics across the industry. Unsurprisingly so, as taken separately they both create major challenges and uncertainties for the industry. Taken together, some might be wondering whether life couldn’t get any harder. With the UK planning to leave the EU two months after the FMD comes into force in February 2019, the whole of the pharma supply chain right from regulatory affairs to contract manufacturing in packaging has some work to do to ensure continued compliance

Two things are for certain however – Brexit will happen and so will the EU FMD. Neither of these is going to go away, so if we’ve not yet started thinking about how to respond, we need to get started very soon. If we leave it much longer, there is a risk that the plethora of point solutions associated with managing regulatory driven content, labelling and artwork creation and packing and print production will increase to the point that it becomes economically unsustainable.

So where does labelling and artwork fit into the big picture here? Well, the first consideration is that having multiple systems and processes hosting labelling content used for regulatory submissions, artwork creation and serialisation data is most likely to be inefficient and prone to error. The second point is that it is very hard to prove compliance when you have to extract and collate information from multiple systems and consolidate this into a single audit report. Thirdly, why choose a discrete physical solution for integrating variable manufacturing data with core labelling content when you can do this up in the cloud electronically?

Here at Kallik, you might have heard us talk about taking a connected approach to artwork and labelling. With Brexit and Serialisation looming on the horizon, embracing both these as an opportunity to create a more open, flexible and sustainable approach promises an easier future for all.

Are you compliant? That’s a question that keeps regulatory affairs executives up at night, particularly in light of increased responsibilities and prosecutions. Where this question becomes even more difficult to answer is with Labelling, since this is an area that traverses so many parts of the enterprise.

Among the factors regulatory affairs must contend with are that very few organizations have complete oversight and most struggle with highly disconnected processes. For example, during the approval process for any Labelling asset, information will likely be sent around the organization in emails or in email attachments. This might consist of a phrase on a label or package, a piece of artwork or a translation required to meet local market regulations. And it’s not easy to trace that information and demonstrate where it originated when it’s managed in such a haphazard way.

Another issue with maintaining oversight is that the vast majority of Labelling activity is driven by required changes. In fact, companies we speak with say changes account for between 75 and 90 percent of their Labelling activities, and most of these changes are regulatory related — because of new legislation or localized symbols or label changes to gain approval for entering a new market. So while the product itself has few or no changes, the Labelling content is constantly being updated and changed.

With so many changes to manage and information coming from multiple stakeholders, it’s difficult to know whether you’re working on the latest approved version, or even if everyone is working from the same version. Changes made locally are often not reflected back upstream, increasing the chances of having multiple uncontrolled versions of the same artwork. It’s a classic problem — how do you know whether you have the latest version? What is the version control process? And who has signed off on the document?

Ensuring Traceability
Compounding this lack of visibility is the demand for greater traceability in light of a heightened focus on patient safety, as well as growing concerns over counterfeiting. If problems arise with products leading to product recalls, such as the breast implant crisis in France a few years ago, being able to trace a product through accurate Labelling is crucial.

If it turns out that you are working on the wrong version and the label that gets onto the market doesn’t have the latest regulatory information or you don’t have proper oversight of that label, you face serious ramifications. For example, your product might be at risk of recall, delayed entry into new markets because of noncompliance with local legislation, wasted time and resources from having to scrap incorrect labels, brand damage, fines, and of course loss of time and loss of revenue.

While you may very well be compliant and your label may meet the various regulatory requirements, the real issue is lack of insight into your Labelling processes. In other words, “you don’t know what you don’t know.”

In my next blog, I’ll explore how you can address these challenges to ensure consistency, oversight and transparency.

Learn more about Labelling by downloading our white paper, “Connecting the Dots Across the Labelling Life Cycle.”

Labelling content & Artwork management leader Kallik’s founder and CEO Neil Gleghorn has been selected as one of the 100 most influential people in the pharmaceutical sector worldwide –

Tamworth, UK August 4, 2014 –Labelling Content & Artwork Management leader Kallik is delighted to announcethat its founder and CEO Neil Gleghorn has just been recognised as one of the 100 most influential people on the global pharmaceutical stage.

The honour is confirmed by Neil being named to the landmark PharmaVOICE 100 List published by the sector’s leading independent editorial publication, PharmaVOICE.

Established nine years ago, The PharmaVOICE 100 is an annual list of individuals determined by their peers as having made the most consistent, outstanding contribution to the life sciences industry, an industry whose UK representatives generate over £50bn in sales every year according to government statistics.

According to the publishers, winners of PharmaVOICE 100 places illustrate what it means to think bigger, do more, and lead with passion and integrity, with all nominations decided by members of the sector.

“I am extremely honoured to receive this industry recognition,” said Neil.

“It is one of the most important peer awards in the pharmaceutical industry, and is testament to the work of everyone here at Kallik – not just me, but everyone from the most junior team member all the way up to the board, our partners and everyone who’s been part of the journey – and most important of all, our customers.”

A long-lasting dialogue

Neil’s extensive knowledge and understanding of the pharma industry’s specific challenges was key to his winning a PharmaVOICE 100 place. That is a knowledge base that he has used to develop forward-thinking solutions that help achieve efficiency and compliance as well as form the basis for on-going dialogues with customers about the long-term challenges they face. “What a third party like a Kallik can do is see the gaps that siloed teams in procurement, regulatory or marketing in a pharmaceutical company just can’t,” he said. “We use that perspective to develop the kind of systems that the pharmaceutical companies of today are increasingly recognising as vital in maximising their opportunity in the market.”

About Kallik

Kallik is a global provider of software solutions that simplify complex artwork management, generation and approval challenges for regulated industries. Its systems help such organisations to reduce the risk of product recall, guarantee product and brand consistency, mitigate risk and reduce costs.

Based on technologies using a structured data-centric approach, Kallik’s solutions leverage and repurpose content to automatically generate artwork.  This enables businesses to remove duplication, track content and rapidly change messaging to respond to new market and regulatory challenges. Formed in 2001, Kallik’s founders and senior management team have a rich heritage in the packaging and labelling industry. The flagship AMS360™ Automated Artwork Management solution was devised based on this insider knowledge of the sector and today underpins the businesses of companies including Sealed Air, Estee Lauder, Coloplast, Integra, Mary Kay and Unilever.

More at www.kallik.com or follow us on Twitter @KallikAMS

About PharmaVOICE PharmaVOICE is expressly written and designed to deliver the views, opinions, and insights of executives who are shaping the direction of the dynamic life-sciences industry. PharmaVOICE, with the largest distribution in its market sector, is delivered to more than 34,000 BPA-qualified subscribers, which include executives from pharmaceutical manufacturing, biotechnology, drug discovery, research & development, contract research, drug delivery, and device/diagnostic companies. The publication also targets decision makers at healthcare advertising, marketing, medical education, public relations, information technology, contract sales, traditional and nontraditional media, and other service support companies and organizations. The publication also reaches more than 100,000 users with its digital edition, which contains original exclusive bonus content. PharmaVOICE’s unique horizontal editorial approach cuts across industry silos, providing a holistic overview of the life-sciences industry, addressing a range of topics from molecule through market. By engaging compelling personalities from diverse industry sectors, PharmaVOICE provides multiple perspectives on business challenges, trends, and topics.

More at www.pharmavoice.com

 

Tamworth, UK – September 19th, 2013 – Labelling Content Management Specialists, Kallik, silver sponsors of the 12th Annual PHPL on 25-26 September 2013, Amsterdam will use the event to encourage pharma and medical device companies, to rethink their approach to artwork management.

CEO, Neil Gleghorn’s conference presentation entitled ‘Would you swap your iPod for vinyl records?’ will take a look at how pharmaceutical and medical device companies are addressing artwork management, the increasing change of pace in product labelling, what causes the quantity and complexity of change and why a staggering 50% of product recalls are due to artwork and labelling errors. Neil will also introduce delegates to a new digital approach to artwork management

The 12th Annual Pharma Packaging and Labelling Europe conference is one of the most longstanding and well established events within this industry sector. Register here to find out more about the event and register to hear Neil’s talk

Labelling Content Management Specialists take Silver Sponsorship at the 12th Annual PHPL on 25-26 September 2013, Amsterdam.

CEO, Neil Gleghorn will be presenting at this year’s event which attracts delegates from all over Europe.

The 12th Annual Pharma Packaging and Labelling Europe conference is one of the most longstanding and well established events within this industry sector. This year’s programme will include updates on new pharmacovigilance legislation, readability hurdles due to increased amount of label information and setting up a global learning system. PHPL has proven itself to be a popular choice for key industry figures to discover new solutions and generate discussion amongst their peers.

Register here: http://www.spgmediadesign.com/test/arenareg/pharmapackagingeurope/register.asp  

by Neil Gleghorn, CEO and Founder, Kallik.

I wonder if I could spend a moment or two talking a little bit about my company Kallik  and about the market and the choices available for delivering efficient, global labelling and content programmes.

We are a UK-based company with very strong roots in the artwork/pre-press origination sector. That’s important because we make the management of content the central hub of the artworks generation service we offer, as we believe that’s the best way to guarantee consistency and clarity for your overall messaging.

At this current time we work with customers in the medical device, cosmetics and chemical industries, working with Fortune 100 level organisations on a global basis.

Why do companies come to a specialist like us?  We talk to managers who have two main problems.

The first problem is, basically, all about compliance. The FDA in the US, the MHRA in the UK, the EMA in Europe – these authorities, fulfilling their mission to better regulate markets and protect consumers, are constantly requiring firms to update or extend their labelling. And you simply have to comply, there’s no alternative.

The second issue is we all hope more of a fear than a reality: product recall. If a product’s information is judged incorrect or inconsistent across different geographies, there is a substantial risk that the product will be ordered to be withdrawn.

Recalls can be very trying, very expensive and very damaging to your brand and reputation: and while the sort of products that we’re talking about can range (as per a European consumer site  on such notices from the European Commission) across all manner of consumer products, the issue is particularly acute in the pharmaceutical arena. For example, according to insurance giant AIG, alerts regarding pharmaceuticals stand at around 28 every year, for reasons ranging from product infection to faulty packaging assembly , while consultants Ernst & Young have said that the estimated cost to American peanut-containing product producers from one 2009 incident of peanut butter contamination by the Salmonella bacteria was a billion dollars.

These are serious figures. That’s why you need to be as well prepared as you can be to deal with both compliance on an on-going basis and for a product recall if that ever happens to you.

That’s why companies from all over the world work with us: because we can provide you with the tools to address both of these pressures.

So, if you are working in regulatory affairs and are therefore tasked with managing content on a global basis for your organisation – or work in corporate quality control and have to ensure all your company’s content is fully compliant across the entirety of the market, we will be able to help you.

BeakersResearch conducted at the 2nd Annual Pharma Packaging and Labelling Compliance Conference in Rome showed that one of the major packaging issues faced by pharmaceutical companies is complying with different regulations for different countries. This is compounded by the need to use text in different languages, which 56% of respondents felt was the most critical element in the packaging and labelling process.

The research, completed by Kallik, Global Vision and AMD Electronic, also highlighted issues faced in the artwork management process, for example: ‘too many approval cycles before final sign-off’ – 41% of respondents cited this as an issue, whilst 38% said that tracking and controlling different versions of approved or rejected artwork was their major issue.

The feedback regarding artwork management solutions was very positive, with almost 70% of respondents stating that an automated artwork management system would provide a fast and easy way to manage change requests from different markets. Neil Gleghorn, CEO of Kallik, a specialist supplier of fully automated artwork management solutions said: “The management of labelling and packaging in multi languages is inherently complex, but the introduction of a fully automated artwork management solution enables effective organisation of phrases and translations to dramatically improve efficiency and aid compliance. This drive to increase automation is clear as there is a need for greater agility when making changes to artwork to meet different regulatory requirements.”

Kallik’s AMS360 Automated Artwork Management Solution empowers authorised Regulatory Affairs and Quality Assurance personnel to make changes directly into print-ready artwork across all types of labelling and marketing collateral in a matter of seconds. This end-to-end enterprise solution is designed to manage the entire labelling and packaging artwork process. AMS360 also enables reviewers to annotate comments online to speed up approval procedures. It automatically creates a full archive of all approved artworks whilst presenting an audit trail of the entire artwork management process, so that different versions can be easily tracked globally and compliance can be proved.

Kallik AMS360The revised EU guidelines on the readability of the labelling and package leaflet of medicinal products are just one example of the rapidly changing regulatory landscape in which pharmaceutical companies operate. By viewing change differently, companies can become more proactive in their patient messaging.

The revised EU guidelines have had a significant impact on artwork and production departments striving to increase efficiency in a global marketplace. One of the major factors is the type size increase – since 1 Feb 2011 the minimum type size increased to 9 points “as measured in font Times New Roman, which should not be narrowed and should have a space between lines of at least 3mm.” Dr. Beate Schaper from Labelling, Artwork and Operations Support in Pfizer Pharma, Germany, researched evolving trends in patient information and legislation. She measured the effects of the type size increase and a practical exercise proved that for each point size increase, the patient information leaflet (PIL) grows about 25%. So, if the point size is enlarged from 6pt to 8pt, the leaflet size may increase by 50%.

This has further implications as cartons may need to increase in size to accommodate the bigger leaflets, and extra stabilising materials may be required. In addition, inserting machines may not be able to cope with larger leaflets or operate within the new parameters. Therefore special solutions, including technology are required, like prefolded leaflets, out serts, etc. Also, larger pack sizes and increased materials require more pallet space and lead to higher costs for transportation and warehousing. The effects are felt throughout the supply chain.

Increased information requirements
When Dr. Schaper studied leaflet trends between 2000 and 2009, she discovered there was also an increase in the amount of information required due to other national legislation and pharmacovigilance procedures. By 2009 the leaflet increased to 157% of its original text size in 2000. The changes were incremental, with the number of artwork updates required dependent on the type of product. For example, centralised authorised products covering new active substances required more than two artwork updates a year on average, whereas well-established medical substances like generic products averaged less than one artwork update a year.

Managing these changes efficiently and accurately is key to the effective running of the packaging operations department and impacts on the entire supply chain. By developing strategies to deal with future changes as well as current ones (such as anticipating additional space requirements), Operations Managers can gain a greater degree of control over the process, rather than continuously reacting to imposed change.

The revised EU guidelines also require clear separation of languages for multi-lingual PILs. Using separate PILs for each language or reducing the number of languages per PIL can overcome this. However, there are then decisions to be taken on country groupings (small countries may require smaller batch sizes), hand or machine packaging and batching of variations. Agreeing a regulatory strategy in advance and tightening up production processes can give businesses greater control and pay dividends later.

Change management
An effective change management strategy is crucial in this rapidly changing regulatory environment. End to end visibility of changes, the ability to take a snapshot at any point as well as see a clear overview of the entire labelling artwork process, all contribute to better change management. Combined with simple, standardised but flexible processes, which are supported by workflow tracking and documentation, these remove some of the headaches caused by new regulations.

The combination of micromanagement and high level coordination ensure that attention to detail is maintained, while seeing the bigger picture of productivity and efficiency. For example, networking teams at regional, local and plant level with a focus on precise and timely communication with clearly defined roles and responsibilities are all crucial factors in managing change effectively.

The revised EU readability guidelines provide an opportunity to re-think patient leaflets. Rather than just making small adjustments to conform to revised regulations, you can achieve additional aims.

Patient-friendly PILs
A Pfizer project together with patient organisations in Germany was initiated in 2006 and focussed on the design of PILs and aimed to improve patient understanding and compliance with medication use. Dr. Beate Schaper reported on the seven key factors in making the PIL more patient-friendly.

  1. Readable font – aspects included font size, font type and weight of paper
  2. Comprehensible language – well written and fluent text that assumed no existing medical knowledge and written in short sentences
  3. Clear information about the disease and action of drug including the benefits of compliant use
  4. Structured layout – including an index and consistent layout so the patient knows where to find the information, spaces between paragraphs, colourful and high contrast layout
  5. Use of pictograms and photos to enhance visual awareness
  6. Use of information boxes to guide the patient to important sections, tips and application methods
  7. Listing patient organisations or other support groups help to reduce the isolation caused by the disease.

Streamlining the artwork management process
Using clearly defined parameters for PILs, not only has the potential to improve compliance with medication use and a better patient experience, it also has the potential to streamline the artwork management process while aiding regulatory compliance.

Forward-thinking pharmaceutical companies are now turning to template-driven Automated Artwork Generation Solutions. They enable the efficient management of messaging, translations and artwork generation to ensure brand consistency and compliance.

Dynamic rule-based templates are set up to meet all the design criteria – such as layout structure, font sizes, colours, branding and regulatory information. These templates are then automatically populated with content from a central database (or asset repository) which includes product descriptions, images, brand logos, regulatory statements, warnings, etc. The templates are then used to automatically generate print-ready artwork for labelling and packaging materials.

Requirements for different patient groups
Once PILs and packaging materials have been developed for general use, they can be adapted for specific patient groups (such as partially-sighted patients). Using a template-based artwork generation solution, this is a straightforward process. It just involves creating a new dynamic template to the required design (for example with larger font sizes, high contrast text, etc.) then pulling the content directly from the master database, ensuring consistency and compliance.

Some countries (such as UK, Sweden and Germany) now have internet portals which provide leaflets in formats for partially-sighted patients and blind people. These are accessible to the public or patient organisations. Also in the UK, the Royal National Institute for Blind People (RNIB) has a Medical Leaflet Line which patients can call to request PILs in large/clear print, Braille or on audio CD. In addition, there is a Leaflet Line which enables patients to listen to the content of a PIL over the phone.

Managing translations
When content in different languages is added to the mix, it results in another layer of complexity. Working out different combinations of languages to be grouped together on a PIL or package can be a time-consuming and costly process, adding unwanted and unnecessary delays. This is another opportunity for template-based artwork generation solutions to prove their worth. Approved content in any language can be easily leveraged from the master database and fed directly into the artwork templates. It is then easy to determine how the text will fit and if the ideal language combinations will actually work.

Gaining greater control
By streamlining their artwork management and production processes, pharmaceutical companies can also gain greater control. It gives them the opportunity to re-think how their product information is displayed and interpreted – and to enhance understanding and compliance from the patient. By planning ahead and anticipating further changes (as far as possible) then they save themselves headaches in the future.

Being one step ahead of the regulators may seem a radical approach for the risk-averse pharmaceutical industry, but by introducing innovative technology that can manage the entire labelling and packaging process, providing transparency and efficiency, regulatory changes can be managed with ease.

By moving from document management to structured content management – where fragments of content and individual elements form the master database – pharmaceutical companies are agile and empowered to adapt to any changes, whether self-initiated or imposed by regulators.

Once these steps are in place, providing patient information in other formats is a real possibility. It could be provided at different levels, tailoring it more closely to the patient’s needs, or separating patient and physician information. Other delivery methods could be considered, such as print on demand by pharmacies or by digital/electronic transfer. Of course, there will be new regulations to ensure that the patient receives their information, but making it more accessible will be advantageous to both the patient and the manufacturer. New technologies enable pharmaceutical companies to view change positively, rather than as a costly burden.