This year I once again had the pleasure of attending, chairing and presenting at the IQPC Pharmaceutical Packaging and Labelling Summit in Zurich on 18th and 19th June. Many thanks to Lucy Comer and the team at IQPC for organising the event.

I presented on the topic Managing Portfolio Complexity in Packaging – Dealing with Small Volume Products, looking at the growing challenge of complexity in packaging portfolios. As companies chase niche opportunities and products become more specialised, large volume packing runs are becoming increasingly rare. However, many pharmaceutical packaging facilities have been designed for higher volume product. Coping with portfolios dominated by small volume product significantly reduces operational efficiencies and drives a large hidden factory of support staff to maintain.

I reviewed some of the environmental factors causing this growth in portfolios and presented a three stage methodology to address the challenges of complexity. Firstly, the portfolio needs to be assessed and understood so that the characteristics and requirements of each SKU are clear. Secondly, sources of non-added value complexity need to be removed to standardise as much as possible. Thirdly, appropriate mechanisms, like postponement and late stage customisation, need to be introduced to provide the necessary complexity in a more effective manner. Finally, I reviewed the sorts of benefits in terms of efficiencies, lead times and costs savings that can be achieved by such a programme.

Other presentations from the event included:

The Role of Packaging and Labelling on Supply Chain Efficiency Prabir Das: Vice President – Packaging Development, Mylan

Prabir presented a broad overview of the interface between packaging and the supply chain. He talked about the commercial and environmental challenges facing packaging and how product characteristics impact packaging design and material selection. All of these issues should be addressed by the packaging system, which in turn should consider all of the requirements that need to be delivered by the packaging design. Prabir also talked about how packaging needs to protect the product, ensuring that the product is fit for use when it reaches the end-user. Finally, he looked at how technology will impact packaging in the future and what barriers will have to be overcome.

Evaluating the Use of Smart Packaging and Interaction with Smartphones Andrew Smith: Technical Packaging Director, GSK

Andrew presented on the use of smart packaging within the pharma industry. He discussed the benefits and opportunities presented by eLeaflets. Smartphone enabled leaflets permit the provision of enhanced product information, for example usage videos. Smartphones can also be used for alerts and compliance, security features and usage monitoring. This improves patient engagement and product security. Andrew reviewed the different types of technology that can be used as carriers to link to product information including tags, QR codes and barcodes. He highlighted the benefits and challenges of each technology and what potential application scenarios might occur.

Solutions to Optimise Your End-to-End Artwork Process Suzanne Ivory: Chief Operating Officer, Perigord

Suzanne presented on the challenges facing pharmaceutical artwork, particularly the impact on patient safety. She highlighted the need for clear processes with detailed instructions to ensure the desirable right-first-time outcome. The implementation of a comprehensive Quality Management System and the underpinning Artwork Management System are key capabilities to support the creation of correct artwork. She also discussed how the introduction of appropriate measures drives performance through focusing on addressing performance deviations. Finally, Suzanne discussed the areas of new technology emerging that will impact artwork processes and capabilities.

Ensure a Return on Your Investment by Implementing E-Labelling into Pre-exiting, Multi-functional Barcodes Tatjana Pathare: Senior Artworks and Regulations Specialist within the Serialisation Project, Roche and Christian Hay: Senior Consultant – Healthcare, GS1

Tatjana and Christian presented on the use of the serialisation barcode to provide a patient leaflet. They highlighted the opportunity of using GS1 Digital Link as the carrier for accessing the eLeaflet as it is an open standard platform. GS1 are now undertaking some pilots to develop this capability. Christian then followed up with a discussion on the ISO standard that is being drafted to support this use of the supply chain identifier to access digital information.

Digital Maturity Model for Packaging: Digitise, Automate and Connect in Pharma Simon Cavanaugh: Senior Account Executive – Global Business Group, ESKO and Steven Brookes: Solution Consultant, ESKO

Simon and Steve presented on the journey companies undertake to manage their digital assets in a comprehensive manner. As the volume of digital assets grows in a company, capabilities also need to evolve to manage assets effectively. ESKO has developed a roadmap tool to help companies with this journey. Simon also explained some of the different use cases they have witnessed for artwork introduction and reasons behind these process variations. Finally, Simon covered some of the other learnings ESKO have witnessed in client implementations, particularly around regulatory processes.

Maximise your Brand Engagement with Patient-centric Packaging and Understand How it Improves Patient Lives Gabriele Iannizzotto: Chairman, HCPC Europe

Gabriele presented on the work carried out by HCPC Europe and the annual Columbus Award for patient safety packaging. He discussed some of the numerous issues facing patients, which can be resolved through improved packaging design. He then introduced some of the previous winners of the Columbus Award demonstrating some of the patient safety / adherence features they included.

What’s Holding Us Back? Identify your Supply Chain Bottlenecks and Risks Jeffrey Hardy: Director General, TRACIT and Suriya Prabha Padmanaabhan: Director of Programs, TRACIT

Jeff and Suriya led a discussion on the issues attendees are witnessing with illicit trade across their supply chains. They looked at each step of the supply chain defining key issues, causes and impacts. This is part of a wider survey they are undertaking across many industry sectors. The outcomes will be captured in a cross-functional business report on illicit trade.

Challenges for Global Pharma Companies to Implement Anti-counterfeit Strategy for Russian Track & Trace Regulation Dr Ettore Cucchetti: Chief Executive Officer, ACG

Ettore presented on the development of secure supply chains across various industry sectors and territories. He compared the maturity of security activities in life sciences against other sectors and examined how capabilities are likely to develop in the life sciences sector. Ettore also discussed each of the elements required for a full product traceability solution.

Putting Patient Safety at the Heart of FMD Leyla Hannbeck: Chief Pharmacist & Director of Pharmacy, National Pharmacy Association

Leyla presented on the patient safety issues associated with packaging and FMD, as witnessed in pharmacies. In particular, she highlighted the significant amounts of ‘look-alike, sound-alike’ errors that happen and how improved packaging design could alleviate these. She presented a number of case studies highlighting the issues where dispensing errors had occurred. Leyla also discussed the impact of FMD on community pharmacies and the preparation activities that have been undertaken to date.

Serialisation and the Future of Hospital Pharmacy Robert Moss: Director of Professional Development, European Association of Hospital Pharmacists

Robert presented on the impact of serialisation and other technological developments on hospital pharmacies. He discussed the problem of identifying the point of authentication in a hospital pharmacy. There are a number of points within the hospital environment where is could be carried out from goods receipt to patient use and each presents challenges. Regarding other technological developments, Robert explained how aggregation would have a significant benefit to hospitals by avoiding having to scan each pack in a case. Scannable single dose primary pack barcoding provides significant patient safety benefits, and EAHP have been advocating this for a number of years. Finally, Robert showed some of the automated drug dispensing and delivery equipment that is being developed.

Fulfilling the Needs of the Local Market with Need-based Packaging Innovation Rajesh Mishra: Associate Director – Packaging Development, Abbott

Rajesh presented on the challenge of designing products to meet local market needs. Focusing on India, he highlighted some of the issues created in a market that is high volume but low cost, with a very high degree of competition. In this environment, needs-based innovation is key to defining how to differentiate your product. Rajesh showed a few examples of packaging design that were developed to meet these challenges. He highlighted a key learning which was making sure that the design of the pack or device was easy to understand and use across many different demographic groups.

EU MDR and its Implications for Labelling and Artwork Karolina Komposh: Labelling and Artwork Manager, Croma-Pharma

Karolina presented on the new Medical Device Regulations. She provided an overview of the regulations, some of the major changes that have been introduced and the timelines to be achieved. She then explained some of the issues that are being discussed between industry and the regulators. As can be expected by such a large piece of legislation, there are many details that need to be further worked to develop practical solutions and time pressures are making these issues more acute.

End-to-End Solution for Managing Labelling and Packaging Artwork Ray Collia: Senior Account Executive, Loftware

Ray presented a clinical trials artwork case study on an implementation undertaken by Loftware. He outlined some of the challenges in clinical trials that can impact the development of clinical trial artwork. He also gave an overview of the business issues that the case study company were wanting to address. He highlighted the benefits that can be delivered through a suitable labelling and artwork system and explained key features of the Loftware system.

Preparing for the Worst : Negotiating with Sites That Have Not Prepared for FMD and Anticipating Brexit Huda Awidi, Regional Regulatory Affairs Manager – Labelling & Artworks – Middle East, Africa, Turkey & Pakistan, Mundipharma

Huda presented on the impact of Brexit and FMD on Middle Eastern / African countries. This is a complex range of countries with many local requirements. She covered the actions being taken to prepare for potential Brexit scenarios which will impact many things including, for example, product licenses due to changes to sites of release. Huda also discussed the implementation of FMD. There is a strong pull in the countries she represents for a serialisation solution, due to the levels of counterfeit product, but countries are at different levels of development. Products are supplied from 60 CMOs so agreeing processes and procedures is difficult. As some countries are implemented and some are not it has also made it difficult to share packs. Finally, Huda explained the methodology they have used to implement serialisation across the region and highlighted key learnings from their implementation.

Morning Workshop: From Manufacture to Use: Overcome the Challenges Encountered during the Three Stages of the Packaging Lifecycle Prabir Das: Vice President – Packaging Development, Mylan

Interactive Workshop: Moving Beyond Compliance – Transitioning from Serialisation to Securitisation Mark Willis: MDR and Compliance, Johnson and Johnson

In addition to the presentations by the speakers above, Prabir and Mark held workshop sessions on the Packaging Lifecycle and Transitioning beyond Serialisation respectively.

It was a pleasure to chair such an informative and engaging two day event, tackling a wide breadth of topics, many of which are constantly evolving as the Pharma Packaging and Labelling landscape responds to many wider industry changes. Thank you to all the speakers and attendees for making a productive and enjoyable session. I look forward to meeting again next year.

Be4ward is a niche consultancy company helping pharmaceutical, biotech and medical device companies and their supply base improve their serialisation, labelling and artwork capabilities. We help clients define the most efficient business processes, organisation design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range.

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