After nearly 10 years since the Drug Supply Chain Security Act (DSCSA) was signed into law, the deadline for tracking and tracing serialized pharmaceutical products across the US supply chain will come into force in November this year.

Most manufacturers have plans and ongoing activity in place to meet this deadline. However, some, often for very good reason, do not. If you fall into this latter category, read on. If you do have plans and activities in place, then chances are that you have worked with one of the Be4ward team at some point over the last 15 years in developing them.

DSCSA requires manufacturers to put in place several significant elements to help secure the US pharmaceutical drug supply chain:

There are many ways to achieve the above, depending on the nature of your supply chain and the scale of your operations. For smaller manufacturers, this will often involve working closely with and coordinating activity across several internal functions, Contract Manufacturing/Packaging Organizations (CMO / CPO), 3rd Party Logistics organizations (3PL), Wholesalers or Specialty Pharmacies and product traceability system vendors.

If you are unsure that your company understands these requirements fully, or that your plans will get you to compliance on time, we are here to help.

Be4ward is one of the longest standing serialization and traceability consultancies, with a team of senior specialists that have worked with many manufacturers, industry groups and standards organizations over the last 15 years, delivering successful serialization solutions.

After nearly 10 years since the Drug Supply Chain Security Act (DSCSA) was signed into law, the deadline for tracking and tracing serialized pharmaceutical products across the US supply chain will come into force in November this year.

Most manufacturers have plans and ongoing activity in place to meet this deadline. However, some, often for very good reason, do not. If you fall into this latter category, read on. If you do have plans and activities in place, then chances are that you have worked with one of the Be4ward team at some point over the last 15 years in developing them.

DSCSA requires manufacturers to put in place several significant elements to help secure the US pharmaceutical drug supply chain:

There are many ways to achieve the above, depending on the nature of your supply chain and the scale of your operations. For smaller manufacturers, this will often involve working closely with and coordinating activity across several internal functions, Contract Manufacturing/Packaging Organizations (CMO / CPO), 3rd Party Logistics organizations (3PL), Wholesalers or Specialty Pharmacies and product traceability system vendors.

If you are unsure that your company understands these requirements fully, or whether your plans will get you to compliance on time, we are here to help.

Be4ward is one of the longest standing serialization and traceability consultancies, with a team of senior specialists that have worked with many manufacturers, industry groups and standards organizations over the last 15 years, delivering successful serialization solutions.

Principal Consultant Grant Courtney provides an overview of the findings of the recent Operation Pangea, looking at what the rise in the fake medicines and the consequences of Brexit means for the UK and what action needs to be taken to protect our supply chains. 

Operation Pangea is an international effort coordinated by INTERPOL, across 92 countries, which aims to disrupt the online sale of fake and illicit health products.

Through the combined work of regulatory bodies, healthcare companies, customs and the police, millions of potentially dangerous medicines are prevented from reaching patients each year.

In addition to seizing falsified product the operation also successfully brings down websites and online marketplaces operated by criminals, dismantles criminal gangs and raises awareness of the risks to the public.

Operation Pangea XIV (2021) ran from May 18 – 25th and it comes as no surprise that products related to the COVID-19 pandemic featured heavily, with testing kits accounting for more than half of all medical devices seized.

The numbers speak for themselves:

• 277 arrests. • 113,020 web-links taken down. • $23m worth or illicit products seized.

What is really telling is the dramatic increase in the value of seized products, up 164% over 2020 numbers.  The UK was a focal point of this year’s operation with over 3 million medicines and medical devices seized with a value of almost $13 million.

Whilst Pangea focuses on the illegal on-line sale of medicines, we must not forget that falsified drugs also enter the legitimate supply chain.  Between 2011 and 2014 thousands of stolen medicines from Italian hospitals were taken out of the controlled supply chain and ended up in pharmacies across the UK, this included Lyrica, the epilepsy drug, but also medicines for prostate cancer and schizophrenia.

Legislation such as the EU Falsified Medicines Directive (EU FMD) has been enacted with the specific objective of providing  protection to patients from Falsified Medicines entering the legitimate supply chain, however since Brexit the EU FMD no longer applies to Great Britain.

In October 2020 the Royal Pharmaceutical Society (RPS) wrote to the health secretary, Matt Hancock and asked for plans to be established to help authenticate medicines that move between the EU and UK.  The RPS were concerned that the removal of safeguards provided by the EU FMD could lead to an influx of falsified medicines.

Clearly Pangea XIV and historical cases show that the UK is a target of an increasing level of criminal activity and the implications of the Pandemic and Brexit leave patients more exposed than before.

Our attention must therefore focus on two important legislative areas, the first is the Digital Services Act (DSA), as this represents an opportunity to help prevent criminals anonymously operating on-line websites and selling to the public.  The second will be the UK legislation which replaces the EU FMD.  Both of these will be critical to the continued fight against fake medicines.

 

Image: Fake medicines seized during Operation Pangea XIV (2021) - Photo source INTERPOL

Associate blog post from Grant Courtney, Principle Consultant

It’s been 15 months since EU FMD came into force and after initial problems bedding in the new systems, false alerts remain a problem preventing the realisation of the full benefits of the directive. With many grace periods now coming to an end, where are manufacturers on the EU FMD journey and what are the real consequences of unresolved alerts moving forward? In part two of the FMD Alerts in 2020 series, Grant Courtney Principle Consultant at Be4ward, looks at the process that happens when an alert is triggered, what manufacturers should be doing and what's coming next in the EU FMD journey.

With false alerts still in play, if an alert is triggered it is necessary to establish if it is due to a technical or procedural error or if in fact it is due to a suspected falsified product. The need to investigate and resolve alerts is stated as a requirement within the Delegated Regulation and the organisation operating the National Medicines Verification System should provide for the immediate investigation of all potential incidents of falsification (Art 37(d)). Moreover, the EU Q&A document makes specific reference that the National Medicines Verification Organisations should ensure the National Competent Authorities (NCA) are informed as soon as it is clear that the alert cannot be explained by a technical or procedural issue.

The MAH has a role to play in this and must check if they have caused the alert by not uploading the serialisation data or if the data has errors. The expectation is that this resolution should happen quickly, within just a few days, and the relevant NMVO is made aware of the outcome of this investigation. In addition, authorities are starting to introduce specific reporting requirements and systems which could vary from country to country.

The common goal remains that we must reach the point at which an alert prevents a pharmacist from dispensing the medicine to the patient, as dictated by the legislation, and with this in mind, ten member states have now ended their stabilisation period.

The resolution of alert errors heralds a new phase in the EU FMD journey, where the target is for investigation and resolution of alerts to happen quickly, with the results documented and shared with the NMVOs and authorities. If alerts are caused by technical or procedural issues within the MAH then Corrective and Preventative Actions (CAPAs) need to be executed in alignment with quality procedures and the data uploaded or corrected to resolve the issue before many more alerts are triggered for the same batch. The consequence of not addressing these false alerts is that the flow of goods will stop and product returns could increase.

So a year after the EU FMD compliance deadline, what should manufacturers be doing and what is coming next?

If manufacturers have not already started, processes and systems must now be put in place to receive, analyse and investigate alerts. The backlog of any alerts that have not been addressed should be cleared and any technical or procedural issues identified and resolved. The regulatory environment should be carefully monitored so that the emerging requirements on alert reporting are captured and built into internal procedures. Regulators are starting to include aspects of the EU FMD within audits and alert management will feature as a topic within these moving forward.

Companies also need to consider how they are going to manage this on an ongoing basis. Tools that have worked for tracking alerts up to now, such as spreadsheets, will reach their technical limit as over time the historical volume of alerts grows. Systems will also have to output to external alert reporting systems operated by the NMVOs and authorities requiring new functionality and potential interfaces.

It is perhaps not surprising that legislation as ambitious as the EU FMD will take some time to achieve its original goal of preventing falsified products from entering the pharmaceutical supply chain. A tremendous start has been made and it is now time to build on this significant foundation and ensure that necessary alert management steps are put in place to allow falsified packs to be correctly identified, only then will the benefits of EU FMD by fully realised.

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of any of our publications, please don’t hesitate to contact me directly on my email: [email protected]

For more information on serialisation strategy and implementation, go to our free download section.

Associate blog post from Grant Courtney, Principle Consultant

It’s been 14 months since EU FMD came into force and after initial problems bedding in the new systems, false alerts remain a problem preventing the realisation of the full benefits of the directive. With many grace periods now coming to an end, where are manufacturers on the EU FMD journey and what are the real consequences of unresolved alerts moving forward? Grant Courtney, Principle Consultant at Be4ward, examines the reasons behind these alerts occurring and looks at the action stakeholders must take now to keep the supply chain flowing.

On the 9th February 2019, new legislation was introduced within the EU with the aim of increasing patient safety by preventing falsified products from entering the pharmaceutical supply chain. The EU Falsified Medicines Directive (2011/62/EU) or EU FMD as it is known, called for a significant overhaul to the existing pharma supply chain system, requiring the establishment and implementation of new organisations and systems needed to authenticate every medicine distributed across the European market.

Initially most of the stakeholder effort was focused on meeting the compliance deadline. For manufacturers this included upgrading productions lines, putting in new IT systems, establishing new processes and running regulatory pack change programmes. Products were generally ready in time across the industry and from the 9th February 2019, as per the directive, all packs which were released onto the market carried a 2D data matrix barcode with a unique identifier (serial number) encoded, along with a tamper evident feature to ensure the integrity of the pack. It would be wrong to believe that hitting the compliance deadline was the end of the journey. In many respects, February 2019 was just the starting point for the EU FMD.

Over 130 million prescribed packs are now scanned every single week. The scale of the systems is impressive, and the EU FMD has fundamentally changed the way in which prescription medicines are manufactured and how they are managed prior to dispensing. These changes present an even greater challenge than the technical ones already encountered, and the implications and impacts are only just starting to surface 12 months in.

For most of the millions of packs being dispensed each day, the pharmacists receive positive confirmation that the unique identifier is valid and, in a status, may allow the pack to be dispensed. When this occurs everything runs smoothly, however not all scans end with a positive confirmation.

The EU FMD systems are designed to identify any unique identifier on a pack which is not in the system or has a status which means it should not be dispensed. When a pack fails to authenticate, the system generates an alert which is distributed to several stakeholders including an alert to the Market Authorisation Holder (MAH).

Alerts generated by the system due to the unsuccessful authentication of a pack are vital as they flag a potential falsified product, allowing action to be taken to address the reason and any potential criminal activity. An alert raises concern over the quality and authenticity of the product, preventing it being dispensed to the patient.

Initially the level of alerts being generated were very high, running at about 6% of all scans. Many of these alerts were false due to two main causes. Firstly, some manufacturers had not managed to upload all the serial numbers into the European Medicines Verification System (EMVS) so missing data was triggering errors. Secondly, the pharmacy systems had not been configured correctly and were introducing errors into the decoded barcode data. These errors included converting upper case characters into lower case and interpreting dates incorrectly.

During the past year, most authorities have taken a lenient view on the alerts, understanding that new software and processes have to stabilise and become embedded. In recognition of this many operated a period of stabilisation, whereby packs that triggered an alert could still be dispensed at the discretion of the pharmacist.

Many of these early problems have now been resolved, consequently the level of alerts has reduced to around the 1% mark as an average across EU countries. However, this level is still considered too high with many false alerts still taking place. It will be progressively more difficult to reduce this further and we can expect this to take many months more to resolve.

In part two of the blog, we examine in more detail the process that happens when an alert is triggered, what manufacturers should be doing and what's coming next in the EU FMD journey.

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of any of our publications, please don’t hesitate to contact me directly on my email: [email protected]

For more information on serialisation strategy and implementation, go to our free download section.

The new EU Medical Device Regulation and In Vitro Diagnostic Regulation are here and companies need to be deciding how they will address them. Approved by the European Parliament in May 2017, these new regulations are the biggest change to the legislative framework for medical device and in vitro diagnostic products in decades. As discussed in my previous blog on the subject, one aspect of this new legislation is the requirement to appoint a Person Responsible for Regulatory Compliance. This requirement has an impact on manufacturers and authorised representatives supplying medical device and in vitro diagnostic product in the EU market. Companies will need to implement many new or enhanced capabilities to meet these obligations.

For companies faced with these challenges, it begs the obvious question ‘So where do we start?’

Define your strategy
The logical first step is to define the company’s strategy for how to tackle the new regulations. Typically, strategy development would include:

1. Understanding of the current and new legislation.
2. Impact of the legislation on the company's operations, including any opportunities that might present.
3. A gap analysis of each relevant aspect of the company’s operations against the requirements of the new legislation.
4. An assessment on existing and pipeline product registrations, testing and labelling.
5. Initial high level designs of potential new processes, capabilities and IT solutions.
6. High level roadmap for re-registrations, testing or re-labelling and implementing new processes, capabilities and IT solutions.
7. Cost and resource impact estimation.
8. Plan for the next phase of activity.

Some considerations when defining your strategy
From our experience of delivering large and complex legislative-driven change, there are a number of things to think about when defining your strategy:

Take a cross functional approach: The impacts of the regulations are cross-functional so make sure that you have all relevant functions involved in defining your strategy. Avoid the temptation to ‘slice and dice’, allowing each function to independently develop their approach. The company needs a holistic response so develop your strategy as a true cross-functional activity. All stakeholder groups involved in the delivery of the legislation need to contribute effectively or the whole process is at risk of failure. Therefore, all parties must buy into their roles in the processes and actively contribute to them. This will rarely happen if they are simply passive bystanders in the design of the capabilities or the delivery of the resulting activities.

Define and agree some governing principles: Providing guidance to the team on what would be permissible or not, defining the ‘rules of game’ to all parties. This provides a boundary and decision-making framework for solutions being developed and should be approved and managed by the governance team.

Ensure effective cross-functional governance: Given the cross-functional and cross-organisational nature of the regulations, establishing the right inclusive leadership and governance is key to the long-term success of the activity. A cross-function governance team should therefore be established to steer the definition, establishment and ongoing delivery of your strategy. This governance body should include membership from all the stakeholder groups involved.

Build in flexibility: The implementation of solutions to address new legislative drivers is complex, not least because through the implementation journey, the legislation evolves.  Unforeseen situations and challenges will arise, timelines may change, Delegated Acts may introduce further local requirements. Therefore, solutions defined need to have sufficient flexibility to cope with further emerging requirements. This is not easy, but is a key challenge of which solution design teams must be made aware.

Look for standard approaches: In large and complex operations, it may be necessary to implement solutions at multiple locations. It can therefore be beneficial to develop standard approaches for solutions that can be replicated at each of these locations rather than ‘re-inventing the wheel’ at each one. This provides two benefits – it can be more efficient in preparing the solutions and learnings across the organisation can be shared. However, if taking this approach, local requirements must be highlighted and built into the developed solutions.

Put a capable, dynamic and motivated leader on the problem: These regulations are complex and evolving, touching many parts of an organisation. With the challenges facing the leadership that is charged with implementing such capabilities, they need to have a broad range of skills, the drive and motivation to anticipate risks and issues, as well as ensure they are effectively managed proactively. Furthermore, there will be many technical challenges to address so the leadership of the program needs to have the technical strength and breadth to succeed in managing these.

Involve local country teams and management early: Good change management practice encourages the involvement of those impacted early in the activity. The local country teams will be key in supporting implementation and ongoing operation of solutions implemented, as well as undertaking a significant role in product re-registration and labelling updates. Involving them early will ensure solutions are fit for purpose and that they buy into the activities you need them to do.

Refresh your strategy as appropriate: The implementation of the new regulations will take many years and requirements will probably evolve. The environment you operate in and your company will likely change in this time as well. Your strategy is therefore not a one-time activity. It needs to grow and evolve as the surroundings change. Hence you need to build in regular reviews of the strategy to ensure it remains pertinent and comprehensive.

Your strategy will help you chart your course
As can be seen from the above, developing your strategy is a key point in your journey to address the issues presented by EU MDR/EU IVDR. It will help your company understand what needs to be done and how resources will be marshalled to address those challenges. The strategy processes need to be timely, giving enough time to undertake the strategy process itself effectively but also giving enough time to subsequently implement the new requirements, and it is an ongoing process tuning the company’s response as situations change. Appropriate flexibility and risk mitigation needs to be built into your solutions and deployment plans. A good strategy will help facilitate a successful response to the legislation across your organisation.

If you are impacted by EU MDR / IVDR, start planning how to transition to the new requirements and avoid supply interruptions. Our Executive Briefing, An Introduction to the EU Medical Device Regulation (EU MDR) can help you understand the legislation and develop a strategy for transition.

Should you have any questions about this or any of my other 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]"/]

‘Driving Innovation and Technology in the Bio-pharma Supply Chain’

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. 

 

Here’s a list of other highlights from the latest US BSMA conference:

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]"/]

 Available for request:
Serialisation Lessons Cover     Serialisation Legislation Cover     Booklet image (2)

For more information on serialisation, go to our free download section.

The new EU Medical Device and In Vitro Device Regulations are here and companies need to be deciding how they will address them. Approved by the European Parliament in May 2017, these new regulations are the biggest change to the legislative framework for MD and IVD products in decades. As discussed in my previous blog on the subject, the impact on device manufacturers and other economic operators is significant with new or changed requirements across the entire product lifecycle. Companies will need to implement many new or enhanced capabilities to meet these obligations.

For companies faced with these challenges, it begs the obvious question ‘So where do we start?’

Define your strategy
The logical first step is to define the company’s strategy for how to tackle the new regulations. Typically, strategy development would include:

1. Understanding of the current and new legislation.
2. Impact of the legislation on the company's operations, including any opportunities that might present.
3. A gap analysis of each relevant aspect of the company’s operations against the requirements of the new legislation.
4. An assessment on existing and pipeline product registrations, testing and labelling.
5. Initial high level designs of potential new processes, capabilities and IT solutions.
6. High level roadmap for re-registrations, testing or re-labelling and implementing new processes, capabilities and IT solutions.
7. Cost and resource impact estimation.
8. Plan for the next phase of activity.

Some considerations when defining your strategy
From our experience of delivering large and complex legislative-driven change, there are a number of things to think about when defining your strategy:

Take a cross functional approach: The impacts of the regulations are cross-functional so make sure that you have all relevant functions involved in defining your strategy. Avoid the temptation to ‘slice and dice’, allowing each function to independently develop their approach. The company needs a holistic response so develop your strategy as a true cross-functional activity. All stakeholder groups involved in the delivery of the legislation need to contribute effectively or the whole process is at risk of failure. Therefore, all parties must buy into their roles in the processes and actively contribute to them. This will rarely happen if they are simply passive bystanders in the design of the capabilities or the delivery of the resulting activities.

Define and agree some governing principles: Providing guidance to the team on what would be permissible or not, defining the ‘rules of game’ to all parties. This provides a boundary and decision-making framework for solutions being developed and should be approved and managed by the governance team.

Ensure effective cross-functional governance: Given the cross-functional and cross-organisational nature of the regulations, establishing the right inclusive leadership and governance is key to the long-term success of the activity. A cross-function governance team should therefore be established to steer the definition, establishment and ongoing delivery of your strategy. This governance body should include membership from all the stakeholder groups involved.

Build in flexibility: The implementation of solutions to address new legislative drivers is complex, not least because through the implementation journey, the legislation evolves.  Unforeseen situations and challenges will arise, timelines may change, Delegated Acts may introduce further local requirements. Therefore, solutions defined need to have sufficient flexibility to cope with further emerging requirements. This is not easy, but is a key challenge of which solution design teams must be made aware.

Look for standard approaches: In large and complex operations, it may be necessary to implement solutions at multiple locations. It can therefore be beneficial to develop standard approaches for solutions that can be replicated at each of these locations rather than ‘re-inventing the wheel’ at each one. This provides two benefits – it can be more efficient in preparing the solutions and learnings across the organisation can be shared. However, if taking this approach, local requirements must be highlighted and built into the developed solutions.

Put a capable, dynamic and motivated leader on the problem: These regulations are complex and evolving, touching many parts of an organisation. With the challenges facing the leadership that is charged with implementing such capabilities, they need to have a broad range of skills, the drive and motivation to anticipate risks and issues, as well as ensure they are effectively managed proactively. Furthermore, there will be many technical challenges to address so the leadership of the program needs to have the technical strength and breadth to succeed in managing these.

Involve local country teams and management early: Good change management practice encourages the involvement of those impacted early in the activity. The local country teams will be key in supporting implementation and ongoing operation of solutions implemented, as well as undertaking a significant role in product re-registration and labelling updates. Involving them early will ensure solutions are fit for purpose and that they buy into the activities you need them to do.

Refresh your strategy as appropriate: The implementation of the new regulations will take many years and requirements will probably evolve. The environment you operate in and your company will likely change in this time as well. Your strategy is therefore not a one-time activity. It needs to grow and evolve as the surroundings change. Hence you need to build in regular reviews of the strategy to ensure it remains pertinent and comprehensive.

Your strategy will help you chart your course
As can be seen from the above, developing your strategy is a key point in your journey to address the issues presented by EU MDR/EU IVDR. It will help your company understand what needs to be done and how resources will be marshalled to address those challenges. The strategy processes need to be timely, giving enough time to undertake the strategy process itself effectively but also giving enough time to subsequently implement the new requirements, and it is an ongoing process tuning the company’s response as situations change. Appropriate flexibility and risk mitigation needs to be built into your solutions and deployment plans. A good strategy will help facilitate a successful response to the legislation across your organisation.

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.

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.

A Case Study: Lundbeck’s Integrated Artwork and Master Data Workflow
Tina Schuleit, Senior Manager, Artwork & Master Data, Lundbeck
Tina presented on what Lundbeck have been doing to integrate artwork change and master data updates. Tina explained that this helps Lundbeck better integrate changes and manage stocks of components. Changes are executed via a workflow in SAP. Tina shared how Lundbeck’s process works and the teams accountable for each step. She outlined the benefits of the capability and the areas Lundbeck were looking to further develop.

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

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.

Following approval in March by the European Council and in April by the European Parliament, the Medical Devices Regulation (MDR) - Regulation (EU) 2017/745 - and In Vitro Diagnostic Medical Devices Regulation (IVDR) - Regulation (EU) 2017/746 - were published in the Official Journal of the European Union on 5th May 2017. Both Regulations entered into force on 26 May 2017, hence the new MDR rules will apply from 26 May 2020 and the IVDR rules from 26 May 2022.

Billed as the most significant changes to medical device legislation in decades, these regulations seek to increase the safety and effectiveness of medical devices available in the EU market and address weaknesses in the regulations revealed in several high profile incidents. Medical device and in vitro diagnostic device manufacturers large and small who supply product to the EU market will be impacted and need to start planning now on how to transition to the new requirements.

There are a number of changes being introduced by the new regulations, some of the most significant being:

The role of economic operators: Economic operators (the collective description for manufacturers, importers, distributors, suppliers, subcontractors and EU authorised representatives) carry the ultimate responsibility for conformity to regulations.  The legislation outlines the general obligations of each or these parties, explaining both what they need to do and how they need to do it.

The scope and classification of products:  Whilst the classification system (Class III, Class IIa, Class IIb and Class I) is retained, some rules have been tightened. Some industry commentators anticipate this could result in some devices moving to higher classes of product. Moreover, a number of types of products that were previously exempt from the regulations are now included in scope.

Technical files, common specifications, clinical evidence, conformity assessments and product labelling:  Additional requirements have been included to each of these aspects of product registration and approval. These may require further product information or testing to be provided to support approval. Transitioning arrangements for existing products or products currently undergoing conformity assessment are being clarified, but some industry experts are concerned that these new requirements could require all products to be registered as they transition to the new legislation.

Vigilance and post-market surveillance: The regulations introduce further requirements for vigilance and post-market surveillance undertaken by both the Economic Operators and the National Authorities.

Quality management system: All manufacturers and their representatives must have an appropriate quality management system.

Person responsible for regulatory compliance: The regulations require that manufacturers and authorised representatives have permanently and at their disposal at least one person responsible for regulatory compliance. This isn’t necessarily an employee, but must be accessible to the organisation. The person is responsible for ensuring the conformity of devices are checked prior to release including that technical documents and certificates of conformity are accurate.

Notified body re-designation: The legislation includes a series of requirements for notified bodies who will be required to be re-designated as part of the regulation. It is targeted to have this complete towards the end of 2018.

Unannounced audits: Notified bodies will be required to undertake unannounced audits of manufacturers and their authorised representatives. Notified bodies will have to provide schedules of unannounced audits to their national authorities.

Medical Device Coordination Group: The legislation includes the creation of a pan-EU expert committee, The Medical Device Coordination Group (MDCG). This will comprise representatives from the member states and will assist the Commission in the implementation and operation of the new legislation.

Unique device identification (UDI): UDIs will be introduced on all medical devices. They will be placed on the label of the device, implant cards for Class III devices, and in the case of re-useable devices, potentially on the device as well. These UDIs will be used to provide traceability of use of devices.

EUDAMED database: The Commission will establish a centralised EU database for the storage of information on medical devices (EUDAMED). This will facilitate the communication of both pre- and post-approval product information between economic operators, the Commission, member states and in some cases healthcare professionals and the public. It is targeted to have this database available towards the end of 2018.

As can be seen from the above changes, the requirements for the new legislation are varied, impacting the majority of parties involved in the supply and governance of medical devices to the EU market across the entire lifecycle of each device. The legislation is in force now so companies need to act to define their strategies for transition

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.