We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.
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 will mean 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.
While helping clients implement serialisation programs and projects over the last 10 years, the Be4ward team has recorded many lessons learnt and continues to do so. This booklet explains some of the key things that we wish we had known before embarking on our early projects.
Serialisation legislation will require 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. The following is a series of tips for developing and implementing your serialisation strategy.
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 document to capture some of our learning throughout that journey and hope it will be useful to you, the reader.
The countdown to EU Falsified Medicines Directive (EU FMD) compliance is underway. With fewer than two years until the serialisation compliance deadline takes effect, industry serialisation leaders, Optel Group, Be4ward and Verify Brand, present a free 60-minute webinar for pharmaceutical organisations that must comply with EU FMD. The webinar, “How to Develop a Robust Plan with Rapid Implementation,” provides pharmaceutical companies with the tools to develop a comprehensive strategy and implementation plan in advance of the February 9, 2019 EU FMD compliance deadline.
The countdown is well under way, with significantly less than two years until the EU Falsified Medicines Directive (EU FMD) serialisation compliance deadline – will your company be ready in time? With 32 countries across Europe being affected by this legislation, in this booklet we will discuss 10 tips to consider whilst developing and implementing your EU FMD serialisation strategy. Avoid supply interruption, make sure you have robust, realistic plans to address February 2019 EU FMD requirements.
We all understand that packaging and artwork still present a significant compliance risk and delivering right‑first‑time artwork is a complex endeavour involving many moving parts. Furthermore, being right‑first‑time increases speed, reduces waste and raises confidence. From this booklet, we can see that achieving high right‑first‑time is doable, but there are many parts to be addressed, requiring focus and persistence. As such, right‑first‑time is as much a mindset as an outcome.
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.If you would like a hard copy of this booklet, please send us an email.
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.
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.
Like all significant change activity, many artwork programmes commence, but not all are successful. Priorities change, resources are constrained, timelines can slip, funds can be withdrawn, and scope can be reduced: in other words, there are many different factors that can cause your artwork improvement project to fail. Over the years, we have learned many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. We have captured these key learnings in this booklet as useful tips to carry your Artwork Program forward. We hope these are useful in shaping your projects and delivering success to your companies.
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.
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.
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. Therefore 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.