I had the opportunity to attend, chair and present at the IQPC Pharmaceutical Packaging and Labelling Summit in Zurich on 20 and 21 June. Many thanks to Katherine Gordon and the team at IQPC for organising the event.
I presented on The Implications of the New EU Medical Device Regulations on Combination Product Packaging. I discussed how the regulations of medical devices and in vitro diagnostic devices are undergoing the most significant change in decades. I outlined the objectives that the legislation seeks to address and the challenging timelines for implementation. I also explained how the legislation impacts the whole lifecycle of medical devices that are marketed in Europe and the complex group of actors impacted. It is clear the legislation introduces some significant changes to the way the EU-marketed MD/IVD lifecycle needs to be managed and it will present a number of packaging challenges.
The presentation can be accessed via the following link: The Implications of the New EU Medical Device Regulations on Combination Product Packaging.
Other presentations from the event included:
A Case Study: Benefits of Offshoring & Centralising – A Graphic Design Perspective
Chikkam Rama Mohan Rao, Senior Director – Global Regulatory, Novo Nordisk
Chikkam presented on the approach Novo Nordisk has taken to establish their Bangalore shared-service operation, by employing approximately 1,700 staff. The operation itself commenced in 2011 and the range of departments based in India allows communication between these departments to be very efficient. Chikkam and his team have looked for many opportunities for activities to be centralised from local operations to raise capabilities, such as renewals management.
The Bangalore operation works hand in hand with the labelling operations team in Denmark to offer an end-to-end solution across the product lifecycle. As part of the outsourcing process, Novo Nordisk did a detailed risk analysis to ensure transition risks were monitored and a set of KPIs monitor the performance of the operation. Benefits seen include a reduction in artwork backlog and improvement in right-first-time.
Get connected: Embrace the Changing Patient Journey and Strengthen Your Brand Across Physical and Digital Channels
Mike Baird, Global Business Development, ESKO
Mike explored the physical and digital challenges impacting product information and healthcare companies. Mike highlighted how patients nowadays are very confident about searching online for information about their health condition. Keeping the physical brand image and content consistent with this digital presence is becoming ever more important.
Companies have many different types of product information stored in many locations and they need to look at how this can be rationalised with better asset management, making sure appropriate stakeholders are involved where needed. Mike also emphasised the importance of rationalised processes with built-in QA/QC.
Current Regulatory Issues and Packaging Changes: Gain Clarity and Develop Solutions
Johan Verhaeghe, FMD Project Manager, Medicines for Europe
Johan presented on Medicines for Europe’s perspective on the adoption of the FMD regulations. Johan outlined the EU FMD legislation framework and the blueprint approach for the European Hub and national systems. The cost impacts on generic manufacturers, wholesalers, distributors and pharmacies and the readiness in each impacted country for establishing their national systems.
Johan discussed some of the issues facing the industry, including:
- The volume of notifications and verification
- The impact on packaging lines
- The ongoing running costs for the new capabilities being introduced.
Why Your Labelling Process is Obsolete
Askold Zimmermann, Account Executive, Global Vision
Askold presented on how the use of electronic proof reading tools can substantially change your artwork workflow by moving away from paper copy content reviews. Askold also discussed the risk with the quality of manual checks and complexities due to different language. The volumes of data and the complexities of networks results in companies needing appropriate artwork management systems to ensure process optimisation and data management.
Packaging Sustainability: Scrutinising the Revised ISO 14001
Horst Kastrup, Senior Regulatory Advisor, MEDA Pharma
Horst presented on the requirements of ISO 14001 and the benefits to companies about being certified to the ISO and adopting sustainable packaging. Horst walked through the updates in the 2015 issue of the ISO that companies will need to meet.
Horst also explained how there are various ways packaging materials can be reused. It is also important to watch out for substances or finishes which might impede recycling. Primary packaging can be challenging to change due to registration requirements, but secondary packaging can be more feasible. Shippers should also be considered. Horst also outlined some core studies of specific products that were assessed against the ISO standard.
Avoiding Labelling Misprints: The Truth Behind the Labelling Review Process
Marc Chaillou, Account Manager, Schlafender Hase GmbH
Marc presented on the typical reasons for artwork error, outlining some of the main reasons for artwork change and the need for accurate and effective labelling and artwork. Marc’s presentation looked at a case study of how an error can happen and the impacts felt. Marc then gave some tips on how to improve the proofreading process through appropriate methods and technology.
Artwork Management Systems: Strategies for Success
Suzanne Ivory, Global Head of Quality, Perigord
Suzanne presented on how to ensure you set up your artwork service for success. There are many drivers that are generating increasing volumes on artwork change putting more complexity into operations. Suzanne explained that getting clear instructions, standards and guidelines is essential to reduce ambiguity. An effective Quality Management System is key to provide the appropriate oversight to your service, and the right measures in place to control operations and focus improvements. Suzanne also covered the benefits of outsourcing artwork operations and discussed how technology is developing and systems are becoming more integrated.
What Are the Main Challenges of Serialisation & Traceability Applications for Packaging Lines?
Julia Guedes Canicali, Project Manager, Novo Nordisk
Julia presented on some of the challenges seen with implementing serialisation in Novo Nordisk. Highlighting the issues that can arise in each of the process steps for how serialisation data flows to and from the line. Julia and her team have seen issues in preparing the lines – defining the print and IT approaches and making space for new equipment. Whilst bringing the data to the line, Novo Nordisk have had to integrate new capabilities to their MES / ERP systems. Different substrates and shapes impact the print performances and print head position. Verification is also impacted by different substrates and can impact line speed.
Master Data Management: The Missing Link in Packaging and Serialisation Initiatives
Chris Doyle, Managing Director, Genshone Transformation
Chris presented on the importance of master data in serialisation and packaging improvements. Through a number of examples, Chris outlined how supply chain effectiveness is underpinned by good data management and standardisation of master data management. Chris also shared some examples of when the product was rendered unsaleable because of errors with master data and raised the question that if this can happen, why are there so many examples of poor data management?
Strategies for Packaging Branding in Pharmaceuticals
Iñaki Remiro, Global Packaging & Design Management, Almirall
Iñaki presented on the relationship between branding and packaging. Iñaki discussed the approach on a range of products that ensured a consistent approach to product branding across Almirall’s packaging. He also emphasised the various aspects of product branding and how companies had achieved this in their packaging design.
Enterprise Serialisation: Best Practice for Global Commercial Supply in an Evolving Market
Robbie Stewart, Contract Manufacturing and Packaging Expert – Pharmaceutical & Biotech, PCI Pharma Services
Robbie presented on lessons learned from the serialisation programmes PCI have been involved in. He first talked about the latest view of the evolving legislation worldwide. Robbie highlighted the challenges serialisation is creating with artwork regarding finding appropriate space for codes and subsequently executing the required artwork changes. Due to the vast majority of PCI’s customers requesting aggregation, PCI have had to introduce increasing levels of flexibility on the packaging suites to be able to meet the needs of multiple clients. This way PCI are trying to future proof their lines and seeing an impact on OEE.
Ensuring Child Safety – and Improving Anti-Counterfeiting
Stephen Wilkins, Chairman, Child-Safe Packaging Group
Stephen presented on the requirements and legislation for child restraint packaging and outlined the various standards and tests that support them. Stephen then explored the impact of child restraint packaging on aging patients and some pack designs that can be easier to use.
GS1 Standards – A Toolkit for Fighting Against Pharmaceutical Counterfeiting
Géraldine Lissalde-Bonnet, Director Public Policy, GS1 Global Office
Géraldine presented on the latest activities GS1 are involved in to help combat counterfeit pharmaceutical products. Outlining the developing serialisation and track and trace regulations around the world and how GS1 standards support the requirements. Géraldine explained how GS1 help shape legislative responses and supports GS1 mentors in their understanding of requirements.
EU FMD Readiness – A Stage Play in Three Acts
Stefan Artlich, Director Product Tracking and Authentication, Bayer AG
Stefan presented on the development and requirements of the EU FMD legislation. Stefan talked about how the legislation evolved and some of the key decisions made during that process. Stefan also highlighted a number of key issues that still need to be addressed, even though the deadlines are close, and what potential solutions might be applied.
Tina Schuleit, Senior Manager, Artwork & Master Data, Lundbeck
Tina presented on what Lundbeck have been doing to integrate artwork change and master data updates. Tina explained that this helps Lundbeck better integrate changes and manage stocks of components. Changes are executed via a workflow in SAP. Tina shared how Lundbeck’s process works and the teams accountable for each step. She outlined the benefits of the capability and the areas Lundbeck were looking to further develop.
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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