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.
Should you have any questions or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email [email protected]
For more information on our areas of expertise, go to our free download section.
The 8th Annual Pharmaceutical Packaging and Labelling Summit is taking place on the 18th - 20th June 2018 in Switzerland. I will be chairing this event. Key challenges will be addressed, surrounding:
I will be presenting a mini-workshop at this event on, How to Identify the Steps to Provide a Comprehensive Artwork, Labelling & Packaging Service. This workshop will explore the impact of portfolio growth and complexity on artwork, packaging and labelling teams. I will be focusing on:
I will also be hosting an interactive round table discussion, Global Regulatory Deep Dive – Identifying Similarities and Differences Across Key Market Requirements. I will be focusing on:
For more information, follow the link to the event organizer website.
This event is will be attended by Be4ward.
Be4ward is a niche consultancy company helping Pharmaceutical, Biotech and Medical Devices companies and their supply base improve their serialisation, labelling and artwork capabilities. Be4ward 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. Corporate website: www.be4ward.com Contact: [email protected]
Join Be4ward at BSMA’s 3rd European Conference for the global life sciences supply chain community, taking place on May 25, 2018 in Lausanne, Switzerland
“Driving Digital Transformation of the Bio-pharma end-to-end Supply Chain”
The world’s leading community of Biopharma supply chain management professionals (Bio Supply Management Alliance – BSMA) will come together for the 3rd time in Europe on May 25th, 2018 in Lausanne, Switzerland.
Business leaders will address the strategic and tactical management of global sourcing, entry into the emerging markets, clinical operations management, information transfer from R&D to clinical trials to commercialization, manufacturing excellence, environmentally controlled distribution, supply chain risk mitigation, and supply chain management talent and career development, while ensuring compliance with expanding government regulations. The theme for 2018 will be: “Driving Digital Transformation of the Bio-pharma end-to-end Supply Chain”
Participate in this conference to:
For more information, follow the link to the event organizer website.
This event will be attended by Be4ward. We hope to see you there.
The Bio Supply Management Alliance was born out of the need to create a worldwide community of operations and supply chain management leaders and professionals in the biotech, BioPharma, and biomedical device industries. It started in the San Francisco Bay Area, home to more than 600 life sciences firms; the Alliance provides a forum for collaboration, learning and best practice sharing of practitioners, executives and thought leaders in these uniquely demanding industry sectors.
BSMA Europe has been launched in partnership with Biolog Europe, a life sciences supply chain association based in Belgium. Sharing values with the US BSMA alliance, BSMA Europe provides a global approach of Life Sciences supply chain organizations’ challenges.
The mission of BSMA Europe is: to build effective and efficient supply chain strategy for the biotech, BioPharma, pharma and biomedical device industries by developing, advancing, and disseminating best practices, knowledge, and research. To encourage and promote supply chain innovation within the biotech, BioPharma, pharma and biomedical device industries for the highest quality and clinical outcomes in patient care and welfare. To create a supply chain community of thought and practice leaders from the business, professional association and academic sectors for information exchange, shared services, and collaboration.
Be4ward is a niche consultancy company helping Pharmaceutical, Biotech and Medical Devices companies and their supply base improve their serialisation, labelling and artwork capabilities. Be4ward help clients define the most efficient business processes, organization 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. Corporate website: www.be4ward.com Contact: [email protected]
Be4ward is proud to sponsor Making Pharmaceuticals UK Exhibition and Conference this year. The event will take place April 24 – 25, 2018, at Ricoh Arena, in Coventry, UK. We hope to see you there.
The team at Be4ward will take the opportunity to present at the event. Neil Wetherall, Consultant, will be speaking on April 25, at 14:00 in Room A. Neil Wetherall will focus on the EU Falsified Medicines Directive –An Update on the Latest Status and Key Learnings From Implementation. I will also be speaking on April 25, at 15:00 in Room A. I will focus on the EU Medical Devices Regulations – An Update on Latest Status and Implications for Combination Products.
This event is proudly sponsored by Be4ward and will be attended by Be4ward.
For more information, follow the link to the event organiser website.
Be4ward is a niche consultancy company helping Pharmaceutical, Biotech and Medical Devices companies and their supply base improve their serialisation, labelling and artwork capabilities. Be4ward 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. Corporate website: www.be4ward.com Contact: [email protected]
Be4ward is proud to sponsor Making Pharmaceuticals Europe Exhibition and Conference this year. The event will take place March 13-14, 2018, at Brussels Expo, in Brussels, Belgium. This event will be attended by Be4ward and I will be taking the opportunity to present. We hope to see you there.
The team at Be4ward will take the opportunity to present at the event. Andy Cumming, Consultant, will be speaking on March 13, at 11:30 in Room B. Andy Cumming will focus on the EU Falsified Medicines Directive –An Update on the Latest Status and Key Learnings From Implementation. I will also be speaking on March 13, at 12:10 in Room B. I will focus on the EU Medical Devices Regulations – An Update on Latest Status and Implications for Combination Products.
For more information, follow the link to the event organiser website.
BSMA really are ‘driving innovation and technology’ with their latest conference. This year, the 10th Annual Supply Chain Management Forum took place in Foster City, CA on 12 October 2017. As a member of BSMA I had the opportunity to attend this excellent event. With more than 200 attendees, it was a great networking opportunity for supply chain thought leaders, supply chain managers and suppliers alike. Many thanks to Pam Gardner, Dave Malenfant, Devendra Mishra and the team at BSMA for organising this event.
As an example of one of the many successful moments at this conference, Kite Pharma – now owned by Gilead Sciences – won the Supply Chain Achievement Award for a very innovative supply chain. Congratulations to Kite on this well-deserved recognition. Kite is an industry leader in the emerging field of cell therapy, which uses a patient’s own immune cells to fight cancer. Kite have developed a patient-manufacture-patient closed supply chain, a remarkable achievement considering the complete process takes between 14 – 16 days. To do this, they not only had to compress many manufacturing steps, but they also had to leverage many connected Information Technology systems to allow real time visibility and management of the end-to-end supply chain.
Overall this conference was a professional gathering of supply chain strategists and I look forward to attending future BSMA events. The next event is currently being organised by BSMA Europe, taking place 25 May 2018, in Lausanne, Switzerland. Click here to keep up to date with the latest details.
There were keynote addresses, presentations, and industry panels, a technology showcase (Multi-Track Break-Out Sessions) were presented by experts in the following areas:
Bio Supply Management Alliance (BSMA) supports continuous learning and improvement of bio supply management professionals and the enhancement of the efficacy of the supply chain of the industry through collaboration. For 10 years, BSMA, the first industry initiative dedicated to bringing together the stakeholders of the global biotech industry supply chain, continues to foster its mission to accelerate the profitable growth of companies by developing, advancing, and disseminating best practices, knowledge, and research through collaboration and networking. This conference has been recognized to be the most informative, interactive, technology-enabling and solution-sharing event in the bio-pharma space where drug manufacturers lead, academia provide research and suppliers/service providers support.
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.
Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me by email.
[dt_sc_email emailid="[email protected]"/]
For more information on serialisation, go to our free download section.
I had the opportunity to attend, chair and present at the IQPC Combination Products Forum in Munich on 24 and 25 October. Many thanks to Romy Tuin and the team at IQPC for organising the event.
I presented on The Implications of the New EU Medical Device Regulations on Combination Products. I discussed how the regulations of medical devices and In vitro diagnostic devices are undergoing the most significant change for 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 challenges to products that are within scope.
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:
Beyond the Molecule – Optimising Combination Product Development Using the E-Health Wave
Steve Dew, Associate Director Combination Products and Medical Devices, Biogen
Steve presented on how digital health is expanding and how this needs to be built into the development of your combination products. Some of the topics covered included:
Steve also presented a number of examples of combination products being developed by healthcare providers.
Platform Technologies For Antimicrobial and Potential Next-gen Ophthalmic and Cancer Fighting Drug-Devices
Drew Rogers, Global Director for Healthcare & Medical, Trelleborg Sealing Solutions and Mark Paulsen, President, Silicone Consulting LLC
Drew and Mark presented on the use of silicone in the medical device industry. They talked about the use of implantable silicone devices impregnated with drug product to support different applications. They provided an overview of two studies they have been involved in, testing the effectiveness of impregnating silicone tubes with various drug products to help enhance the effectiveness of the impregnation process.
MHRA Perspective: Understanding The Regulatory Landscape For Combination Products
Dr Stefania Ragone, Pharmaceutical Assessor Licensing Division, MHRA
Stefania presented on the regulatory environment for combination products in Europe. She drew attention to two significant aspects of the European regulations:
Stefania discussed the requirements of the regulations and, through a number of examples, some of the pitfalls to avoid when preparing submissions.
Using Design Control to Aid in the Development of Combination Products
Margaret Kelly, Device Development Project Leader, Novartis
Margaret presented on the use of design controls in a medical device development process. She walked through a typical development process to show how this would fit to a design control framework and how you can use the design history file to collate the information gathered in the development of the device. This led to a conversation on how the device and drug development processes interlink and how they should be managed.
Cockpit’s Guided Compliance For Medical Device And Combination Product Development
Edwin Schumacher, Managing Partner, Synergio
Edwin demonstrated Synergio’s guided compliance tool for product development – Cockpit.
Edwin provided an overview of the product’s key features and benefits and, by way of a specimen project, demonstrated the functionality of the system.
Optimising and De-risking Device Development of Combination Products
Peter Czuczman, Global Project Leader Drug Device Product Development, BTG
Peter presented on the work he is undertaking in BTG to de-risk device development for combination products. Initially Peter gave an overview of the legislative environment and the implications presented for product development. He then discussed how you can take the regulatory frameworks to develop your drug and device development processes, de-risking the processes by making sure the regulatory requirements are built in.
To conclude, Peter explained which standards support which parts of the development process and how a suite of standard tools can underpin the process and make it more repeatable.
Applying The TRIZ Methodology To Medical Device Innovations
René Dathe, Head of Quality Medical Devices Shared Function, Novartis
René’s presentation covered the use of the TRIZ methodology in Novartis and how it can be applied to medical device innovation.
The TRIZ methodology is an alternative problem-solving methodology that was originally developed in Russia and can be applied to technology driven problems.
René explained a case study they used to test the methodology using an auto-injector product design.
Harmonizing the Integration of Drug Developments and Device Approaches
Lori-Ann Woodard, Senior Manager Quality Compliance Combination Products, Teva Pharmaceuticals
Lori-Ann presented on how to align the legislative requirements for devices and drug products. In particular Lori-Ann looked at what you need to do to have one comprehensive QMS in your company, depending on whether you base your QMS on the requirements for drug products or devices.
Lori-Ann also looked at how key milestones in the drug products and device development methodologies can be aligned to give one seamless development approach.
Navigating the Different Regulatory Pathways for Combination Products Across the EU and US
Lars Hyveled-Nielsen, Regulatory Project Director, Regulatory Affairs, Zealand Pharma
Lars’ presentation focussed on which regulations apply to medical devices and drug products in the EU and US.
Lars explained how single-use devices and multi-use devices have different regulatory approaches in the EU. Lars explained the different requirements for each.
Lars also explained the regulatory requirements for combination products in the US and how these differ from the EU.
Human Factors Engineering for Combination Products
Heidi Manijeh Mehrzad, Principal Human Factors Specialist, HFUX Research
Heidi provided a comprehensive and wide-ranging presentation on the requirements for human factors studies in medical devices. Heidi explained the requirements for such studies and how they fit into the overall device development process.
Heidi highlighted the benefits from a well-thought-out human factors study approach and discussed numerous best practices to consider, in defining your human factors study approach.
How to Compile a Clinical Evaluation for Combination Products
Florian Tolkmitt, Independent Regulatory Affairs and Clinical Evaluation Expert
Florian talked about the clinical evaluation requirements for combination products. Florian provided an overview of the requirements for clinical trials in the new EU MDR regulations.
Florian outlined the processes and documentation requirements that companies will need to apply to their clinical evaluations through the new regulations and discussed a number of challenges that companies will need to meet.
Be4ward is a niche consultancy company helping Pharmaceutical, Biotech and Medical Devices companies and their supply base improve their serialisation, labelling and artwork capabilities. Be4ward help clients define the most efficient business processes, organization 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. Corporate website: www.be4ward.com Contact: [email protected]
Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email. [dt_sc_email emailid="[email protected]"/]
IQPC Pharmaceutical Packaging and Labelling conference in Basel
I spent a few days last week at the IQPC pharmaceutical Packaging and labelling conference in Basel.
A big thank you to Anastasia, Michael, Gerald and the team at IQPC for organising another excellent conference.
Key highlights included:
World Customs Organisation: The Global Approach to Combat Counterfeits.
Benoit Goyens, World Trade Organisation
The first presentation was by Benoit Goyens at the World Customs Organisation. Benoit discussed the IPM tool, a tool to foster collaboration between customs officers and rights holders. The tool allows a significant amount of information on products, supply routes etc. to be held and be available to customs officers. It also provides a repository for previous incidents for reference. The tool has been rolled out to 74 countries and deployment continues. A smartphone app has also been developed to allow customs officers to access information in the field. Deployment continues with more countries being added and the development of future functionality, for example the incorporation of authentication.
Latest Developments around the European Medicines Verification System, EMVS
Marcel De Grouter, Abbott
Marcel provided an update on the progress of the European Stakeholder Model and the deployment of FMD and the EMVS. The EMVS is targeted to go live in 2014 and work progresses with securPharm in Germany to make this happen. Ramp up is expected from 2015 through 2018. This is partially dependent upon the publication of the delegated acts in Q1 2015.
Practical examples for T&T from all over the world
Hendrik Kneusels, Antares Vision
Hendrick shared examples of projects that Antares Vision has been involved in the learnings they have gained from those projects. Items such as the involvement of many functions across the organisation, redesign of packaging materials to work effectively with printing and reading capabilities on the lines and the hierarchy of IT solutions required were discussed.
Hendrick also discussed how the ongoing development of new tools required for serialisation can restore operations to levels of OEE witnessed before.
Ensuring accurate and on-time packaging artwork in an ever more complex Global Regulatory Environment
Andrew Love, Be4ward
I facilitated a team discussion session on labelling and artwork issues. In four groups, the conference participants discussed one of four questions:
We then shared key points from these discussions.
Pharmaceutical Products integrity and Authenticity as essential requirements of the FDM 2011/62/UE
Andrea Dellepiane, Pilot Italia S.p.A.
Andrea discussed the requirements of FMD and the different solution required for serialisation, anti-counterfeiting and tamper evidence and how the three topics need to be considered together to protect the patient. Andrea also discussed the developing European standard for tamper evidence and the different types of sealing technology available.
Exclusive insight into Generics and the Packaging Industry
Maarten Van Baelen, EGA – European Generics Medicines Association
Maarten updated the audience on the Generic Pharmaceutical industry and the impacts and position of the Generics industry to the FMD legislation. He outlined the generics companies concerns regarding the cost of implementation of FMD, the impact on product profitability and line efficiency and the risks to supply during implementation. The challenges associated with an EU-wide risk assessment and cost allocation were also highlighted.
Tamper Evidence for pharmaceutical packaging
Andreas Brandt, Baumer HHS
Andreas presented on the regulations, standards and solutions available for the tamper evidence requirements of FMD. He discussed the opportunities and challenges associated with different types of adhesives. He also highlighted the timelines required to implement tamper evident solutions and the need to be starting soon!
Best Practice approaches to Lean Transformation in Pharmaceutical packaging
Klaus Hjortgaard Olsen, Lundbeck
Klaus presented on the improvements that have been made in his packaging operations through the application of lean techniques across the organisation. This has been a significant journey for the company and a significant cultural change. He also outlined the programme that Lundbeck is going through. The programme has freed so much capacity that they have been able to bring back In house product packaging that was undertaken at CMOs whilst also seeing a significant increase in product range.
Information about medicines: What patients get to see?
Karel van der Waarde, Pharmaceutical Consultant and Graphic Design Researcher
Karl presented on the patient safety aspects of packaging. In particular, he looked at the impact of legislation, which is often defined to support manufacturers and distributors, on end users especially the elderly. He discussed the implications of tamper evidence on openability and what companies should be considering to improve the patients’ use of packaging
Optimising Product Information on Packaging: Optimising Information on a reduced surface area
Catherine Libilbéhéty, Sanofi
Catherine talked about the growing requirements for information to be provided on packaging and the challenge of available space. She gave an overview of the European labelling regulations and some of the techniques she has used to address the challenges for space. She also outlined the opportunity for the incorporation of QR Codes on pharmaceutical packaging and the implications these may present.
Leaflet Paper: A genuine speciality paper market
Keith Rousell, Bolleré Thin Papers
Keith talked us through the developments underway in the paper industry. He discussed the types and uses of different types of paper and the characteristics that are important for the applications in the pharma industry. He also discussed the changes in technology that are providing new opportunities e.g. digital printing, and the industry requirements and Bolleré’s response to sustainability.
Managing product packaging complexity in a global marketplace
Andrew Love, Be4ward Ltd
I presented on the challenges increasing product ranges are creating for product packaging and some of the opportunities for managing this complexity.
Integrated IT and Automation Concepts for Serialisation and Product Tracking
Christoph Staub, Laetus Group
Christoph presented on the IT requirements for serialisation. He covered the architecture required from the line level to the corporate layer, the capabilities needed at each level and how to ensure a flexible architecture is implemented. He also highlighted the growing importance of integration capability as solutions extend across the supply chain and multiple systems/partners.
Packaging Design to help improve Patient Compliance
Hinrik Petursson, Actavis
Hinrik presented on how packaging design can improve the patient’s adherence to their regime. He looked at some of the reasons behind poor adherence why it is important that adherence is improved. He reviewed a number of packaging design techniques for different dose forms that can help raise adherence and monitoring devices available to warn when medicines should be taken.