Today I read about falsified COVID-19 vaccines being identified in the Islamic Republic of Iran. This demonstrates that the fight against fake medicines is ongoing and serves as a timely reminder about the risks being faced by patients.
Medical Product Alert N°7/2021: Falsified COVID-19 Vaccine AstraZeneca (who.int)
Medical Product Alert N°6/2021: Falsified Pfizer-BioNTech COVID-19 Vaccine (who.int)
Why was this so timely . . . ?
Only yesterday I had the privilege to join a panel at the GS1 Healthcare 3rd Online Summit. The session focused on the progress being made in Africa, on the journey towards Healthcare Supply Chain Traceability.
The session chaired by Tom Woods, Global Steering Committee for Quality Assurance - World Bank, highlighted the progress being made in countries such as Nigeria, Ethiopia, Zambia, and Rwanda.
Also included was a presentation of the Verification and Traceability Initiative, which is supporting countries to reduce the urgent risk of falsified and diverted health products. Initially focused on COVID-19 vaccines, the initiative has a vision of working towards national traceability of all vaccines, medicines, and health products.
UNICEF and its partners (USAID, Gavi, The Global Fund, The World Bank, Bill & Melinda Gates foundation) provided an overview of the repository, currently being set up, which will allow the verification of COVID-19 vaccines, using GS1 standards.
Whilst systems alone will not fully address the risks, when combined with other interventions, such as destroying used vials and packaging after use, we can make a difference in the fight against fake healthcare products.
One of my takeaway thoughts, having participated in the Summit, is that we are now at the start of the next wave of countries which are embarking on their journey towards Healthcare traceability. There is also a tremendous drive by these countries to deliver the benefits which we have seen in places such as Argentina, Turkey, and the European Union. We must support these countries and use the knowledge and experience gained over the past ten years of traceability deployment to help them be successful.
There is no doubt that we are going to see more Lower Middle Income Countries (LMICs) adopting GS1 standards to increase supply chain visibility and secure the supply chain. We must all do our part to support these countries on their journey towards traceability, to ensure we protect every patient from fakes.
Grant Courtney
Principal Consultant - Be4ward
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.
I had the opportunity to attend, chair and present at the IQPC Pharmaceutical Packaging and Labelling Summit in Zurich on 18 - 20 June. Many thanks to Katherine Gordon and the team at IQPC for organising the event.
I presented a mini-workshop on How to Identify the Steps to Provide a Comprehensive Artwork, Labelling & Packaging Service. In the workshop I explored the impact of portfolio growth and complexity on artwork, packaging and labelling teams. I focused on what capabilities you might introduce to meet the challenges of growing product portfolios. I also looked at how to engage your organisation to make necessary enhancements compelling. Finally, I explored how to ensure you deliver successful outcomes.
I also hosted an interactive round table discussion, Global Regulatory Deep Dive – Identifying Similarities and Differences Across Key Market Requirements. I focused on analysing the global regulatory landscape – how black market trade and product counterfeiting threatens the supply of pharmaceuticals across borders. I also looked at how to ensure market compliance by identifying key international areas of regulatory similarity to exploit and differences to prepare for ISO 21296 – looking towards the new international standard on Tamper Verification techniques.
Other presentations from the event included:
GS1 Standards - A Toolkit for Fighting Against Pharmaceutical Counterfeiting
Tania Snioch, Director Healthcare, GS1 Global Office
Tania introduced the role of GS1 and how GS1 standards underpin serialisation and traceability. Tania explained how GS1 works with partner organisations through the Joint Initiative Council.
Tania also discussed the impact of counterfeit drugs in developing countries. Tania also highlighted the benefits of standardisation to hospitals and their supply chains. Finally, Tania outlined the regulatory requirements for serialisation and traceability across a number of countries that are legislating solutions.
Let's Dream Big! Clearly and Quickly Connect with Patients and Consumers Through Packaging and Labelling Artwork
Simon Cavanagh, Account Executive Brand Solutions, and Steven Brookes, Pre-Sales Solution Architect Brand Solutions, Esko
Simon and Steven talked about the digitalisation of packaging tools and packaging design, and how this will change the approach to packaging design in the future. Simon and Steven also gave an overview of Esko’s tools, the enhancements that Esko have been working on, and how they address the growing challenges brought on by digitalisation.
Solutions to Optimise your End-to-End Artwork Process
Suzanne Ivory, Global Quality Director, Perigord
Suzanne talked about how artwork fits into the overall end-to-end labelling process. Suzanne discussed key drivers for change that are impacting labelling and artwork including product proliferation, data security and an increased focus on pharmacovigilance. Suzanne distilled this down to the key challenges to artwork and the solutions required to meet them. These included the need for a quality management system, an artwork management system and carefully selected long-term partners.
Anti-Counterfeiting Requirements with a Focus on Non-EU Areas
Horst Kastrup, Senior Regulatory Advisor, MEDA Pharma (retired)
Horst presented on anti-counterfeiting requirements, particularly outside of the EU. Horst highlighted the magnitude of counterfeit products in low to medium income countries, particularly antimalarials, with estimates of 1 million deaths per year due to counterfeit products.
Horst discussed several case studies across a number of products and countries. Horst also outlined the various regulatory requirements that have been introduced to address this.
Implementing Child Resistant Packaging Without the Tantrum
Stephen Wilkins, Chairman, Child-Safe Packaging Group
Stephen presented on the requirements for child resistant packaging and the background reasons for these requirements. Stephen provided an overview of the various regulations and standards. Stephen showed a number of failure modes and some examples of good practice.
Stephen also discussed the impact of packaging design on the elderly, which can be detrimentally impacted by child resistant features.
Purchasing for Patient Safety - Payer's Influence on Assessment of Packaging & Labelling for UK NHS Hospital Formularies
Omar Ali, Formulary Development Pharmacist, QIPP Advisor Payer Network and Former Formulary Advisor, UK National Health Service (NHS)
Omar’s presentation covered the role of packaging in patient safety. Omar talked about the environment of medication errors and the impact on patients and healthcare professionals. Omar showed the impact of similar product names and discussed potential systems solutions e.g. electronic prescribing tools.
Omar then looked at labelling issues and what was needed to resolve them. Referring to the NPSA guide to packaging design, he showed how layout and colour can be used to help highlight specific product issues.
Overview of the FMD Challenges and Opportunities for Hospital Pharmacies
Robert Moss, Board Member & Director of Professional Development, European Association of Hospital Pharmacists
Robert discussed the implications of FMD on hospital pharmacies. Robert looked at the hospital supply chain and the issue of when the product should be authenticated within the hospital. This is a complex issue for many hospitals where they are integrated with other healthcare facilities.
Robert then discussed the other issues presented by FMD on hospital pharmacies. This included the impact on pharmacist capacity and workload, processes for product rejection and return, and impacts on cold chain product.
BfArM Pharmacovigilance Inspection - Case study from a labelling point of view
Hannah Hähl, Regulatory Affairs Manager (Labelling), Grunenthal
Hannah presented on the learnings and improvements made to Grunenthal’s labelling process following inspection observations. Hannah gave an overview of the inspection process and activities. Hannah then discussed the need for more end-to-end oversight of safety variations and the introduction of a tracking tool and other process improvements they have undertaken. Hannah highlighted that regulators are increasingly looking for end-to-end oversight that safety changes are implemented in a timely manner, but that inside a company, implementation can mean different things.
Case Study - Improving Artwork Process Efficiency on a Global Scale
Russell Collins, Director, Packaging Strategy and Global Labelling Business Process, AstraZeneca and Paul Goldberg, Vice President of Product Strategy, Loftware
Russell and Paul presented on the improvements that AstraZeneca have been undertaking and the implementation of Loftware’s artwork management system. Paul gave an overview of Loftware, the acquisition of Gap Systems and how their product offering will evolve. Russell explained AstraZeneca’s process maturity development model and how their capability improvements have been prioritised. They are now at the stage of considering how the labelling and artwork process will be seamlessly integrated into the overall company process architecture.
Russell showed how the improvements they are making are aligned to the company’s goals and the benefits these improvements will deliver. Russell emphasised the need to focus on improvements that clearly support business requirements.
The Trials and Tribulations of a Labelling Professional
Keith Howard, Former Senior Labelling Manager, Vertex Pharmaceuticals
Keith discussed the issues faced by Regulatory and Labelling professionals. Keith walked through the life of a typical change, highlighting the issues that can arise in execution. This showed the amount of variability that can arise in the process due to different problems that can occur. Keith also emphasised the need for collaboration across and outside of the company. Regardless of the application of artwork management systems, there are still a high degree of people involved and many issues arise due to differences in opinion. Someone needs to be accountable to resolve these issues and ensure changes are delivered on time.
Increasing therapy adherence through packaging: Designing packaging that improves patient's lives
Ger Standhardt, Executive Director, HCPC Europe
Ger presented on how packaging can improve the life of patients. Ger explained the remit of HCPC Europe and the purpose of packaging. Using examples of HCPC Europe Columbus award winners, he highlighted features on packaging that improve patient adherence. These include; calendarisation, portability and discreteness, child resistance, ergonomics and provision of usage information.
How to Prepare For Delivery Of The FMD On Time And Final Considerations To Be Made
Johan Verhaeghe, National Policy Liaison, Medicines for Europe
Johan discussed the FMD regulation deployment. Johan outlined; the FMD regulations, explained the European Stakeholder model, the European Hub and national systems, and the roles of the different participants. Johan then explained that deadlines are imminent and there is still much work to do in many organisations. Country preparations are progressing but there is a concern that some may be late.
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 directly on my email.
For more information on artwork, 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.
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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]"/]
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:
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.
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 directly on my email.
For more information on artwork, go to our free download section.