Our highly qualified team of consultants collectively possess a diverse skill set, informed by decades of practical experience gained from working on the factory floor to working with the boardroom. We share our extensive experience in key areas of expertise through a series of executive briefings, white papers, reports and other publications to assist, educate and inform. Feel free to download these publications and share them with your colleagues. You can also request a hard copy by completing the form.
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A report written by Grant Courtney, Principal Consultant at Be4ward
The EU Falsified Medicines Directive (EU FMD), legislation passed by the European Union Parliament, has been in force since 9th February 2019. The intention of the directive is to increase the security of the manufacture and delivery of medicines in the EU and to provide protection to patients from falsified medicines entering the legitimate supply chain. In this 2020 report Be4ward looks beyond the prevention of falsified medicines to help understand what other benefits can be gained in the hospital setting. The report, commissioned by EFPIA, illustrates how benefits exist at all points across the hospital supply, where the EU FMD pack is handled, stored and processed including in logistics, manufacture & transformation and clinical.
Serialisation legislation requires new capabilities to be implemented across many different functions of a typical company such as regulatory and legislative management and government affairs, packaging operations, distribution operations and IT. These capabilities must be implemented effectively in a timely manner to ensure product supply is maintained. This booklet outlines our top ten tips for developing and implementing your serialisation strategy.
While helping clients implement serialisation programmes and projects over the last 15 years, the Be4ward team has recorded many lessons learnt. This booklet explains some of the key things that we wish we had known before embarking on our early projects.
Pharmaceutical product serialisation legislation is being developed and approved across the world to help ensure patient safety and prevent reimbursement fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with the legislation means that companies cannot sell products in the affected markets. This White Paper explains this legislation, its impacts and describes how pharmaceutical companies should tackle the legislation in the most effective way.
For many Pharma companies, the use of contract manufacturing organisations (CMOs) to package commercial product is an integral part of their supply chain. Indeed, for virtual companies, it may be the only way their products are packaged. Be4ward has been implementing serialisation with Pharma companies and CMOs for many years. We have written this Executive Briefing outlining eighteen of our key learnings throughout that journey.
The essential resource for implementing sustainable packaging labelling and artwork capabilities. Foreword by Steve Richmond, Head of Global Packaging, AstraZeneca. The knowledge and expertise contained in this book will help you to understand and deliver the right mix of packaging artwork capabilities for your organisation, in a shorter period of time, at lower cost and with signiﬁcantly less risk. Inside you will ﬁnd in-depth discussion on the following topics: The importance of artwork capabilities in delivering today's business strategy, the causes of artwork errors, detailed discussion on each of the elements which go to make up the overall artwork capability, including: business processes; education, training and competence assessment; organisation design; technology and outsourcing, making sustainable improvements happen and future developments.
Artwork Process Book Review … Must Read!
I approached reading this book with a touch of scepticism having been in the Artwork creation space all my working career, however I can confirm that it is a ‘must read’ for anyone associated with Packaging Labelling and the Artwork creation process.
Packaging and artwork creation presents a significant compliance risk and is critical to deliver a business strategy. As regulations change and adherence increases, product portfolios grow, routes to market get more complex and global in scale. Only a best-in-class, agile artwork development process will ensure your products are in market. As one senior VP of Labelling emphasised “without compliant packaging and labelling, you cannot sell your product in a market”.
Whether you are a VP or Director of Global Labelling, Artwork Manager or heavily involved in the review and approval process, this book offers an informed perspective on both the Artwork right-first-time process and the governance of cross-silo interactions and accountabilities. Although the book focuses on the Pharmaceutical sector, I can confirm it provides recommendations that benefit all sectors.
For those developing or supplying Artwork & Labelling solutions, it offers great insight and a set of high-level requirements for fundamental features that are often overlooked by vendors viewing a business from an external perspective.
When discussing the pitfalls of human proofreading, it uses one of the best renditions of Cambridge research to evidence that the human brain can decipher words even when the middle letters are scrambled. “Cna yuo raed tihs? 55 plepoe out of 100 can. The author provides a paragraph in this style to illustrate the importance and accuracy supporting text verification software can bring.
There are other areas around governance, defining KPI’s, budget planning and business continuity that are often neglected by writers on this subject. It also touches on what I believe will be the next major evolution in the artwork and labelling space, eLabelling or off-pack messaging.
Finally, there is an informative chapter on making it happen and confirming that excellence is achievable.
As stated in the opening paragraph, this is a ‘must read’, but why not make up your own mind.
Review by Ashley Goldie, former MD of Kallik Ltd. - October 2020
We list the top 20 things to consider when auditing pharmaceutical packaging labelling and artwork content creation capabilities. The booklet is designed to help auditing professionals improve their auditing techniques.
Proofreading is a critical quality control step in the process of ensuring that the packaging labelling and artwork of finished pharmaceutical product is correct. Mistakes in this artwork can put patient safety at risk. Therefore, ensuring that there are adequate processes, people, facilities and tools in place to perform high quality proofreading activities is essential to patient safety. This booklet identifies a number of errors which are typically seen in the design and execution of proofreading capabilities which should be avoided to ensure a quality proofreading result.
‘Right-First-Time’ is the fundamental metric for an artwork service. This is a simple pass or fail metric — did the artwork pass through the process once or was any change required? This is difficult to achieve on a consistent basis and requires focus and persistence. This booklet explores this subject further outlining our top 10 tips.
Packaging artwork is a complex but often overlooked aspect in the design of pharmaceutical products. Unfortunately, packaging artwork errors are one of the main causes of product recalls. Many factors are driving companies to increase their product range. This brings with it a corresponding increase in the risk of artwork related recalls and near misses. In this White Paper, we draw on our extensive experience of designing, implementing and managing global packaging artwork capabilities to help you understand how to minimise these risks.
As globalisation increases and companies reach customers in many more markets around the world, the need for accurate and comprehensive translations increases. Translation activity is an often forgotten back-room process. It is rarely considered core to a company's operations, but failure in the process results in incorrect information being provided to customers, suppliers, regulators or shareholders. At minimum this is embarrassing and may not show the company in the best light. However, some errors can be significant, impacting the safety of the customer or agreements with regulators. These can seriously damage the company's reputation and lead to sanctions and fines. This booklet provides a series of tips to help you establish your translation capability based around a 10 step process.
Establishing and delivering improvements in artwork capabilities is a significant, but achievable change management challenge. Delivering change in this area requires the management of a complex interaction of business processes: people in many different functions, organisations and countries using many, often validated information technology tools. This requires careful and skilled project and change management skills to do it effectively if significant compliance risks are to be avoided. We have captured these key learnings in this booklet as useful tips to carry your artwork programme forward.
Stock Keeping Unit (SKU) and packaging component portfolio control is a critical activity for organisations. Ensuring the correct balance between a commercially advantageous portfolio, whilst minimising unnecessary pack and component variants is a challenge faced by many healthcare product companies as they grow their product range and expand into new markets. Ensuring there are decision making processes in the organisation to manage required levels of complexity is a key aspect of effective pack management. This booklet takes the popular top 20 tips format to describe key features of a complexity management capability in an easy to digest format.
We draw on our team's award-winning experience in the management of product licence and packaging changes in the aftermath of mergers and acquisitions to explain how to achieve this complex task whilst minimising supply risk and cost.
Billed as the most significant changes to medical device legislation in decades, these regulations seek to increase the safety and effectiveness of medical devices available in the EU market and address weaknesses in the regulations revealed in several high profile incidents. Medical device and in vitro diagnostic device manufacturers large and small who supply product to the EU market will be impacted and need to start planning now on how to transition to the new requirements.