I recently attended the IQPC Pharmaceutical and Labelling Summit in Basel. As well as presenting on the topic of complexity management, I chaired Day 2. Attached are my notes from the various speakers.
Best Practices on how to ensure Pharma Contact Packagers compliance with ePedigree law and EU Directive on Falsified Medicines
Michael Ritter, Global Project Manager Serialisation and Product Tracking, Novartis
Michael’s presentation covered the importance of including contract packagers in your serialisation project plans. Whilst it is a challenge to prepare and equip internal factories for the forthcoming serialisation legislation, Michael highlighted the additional complexity associated with including external supply organisations. These companies need to be involved in the programme but the solutions required may be different to the internal factories and of course external suppliers have demands from their other customers. Understanding the capabilities, impact and implementation strategies for each supplier is a key part of a serialisation strategy and needs to be considered fully when developing your overall company plan.
Implementing ePedigree in a Global company – the challenges
Ezri Deshen, Senior Director – Solid Operations, Global Operations, Teva Pharmaceuticals
In his presentation, Ezri explained how Teva is organising their project teams to meet the various serialisation legislations around the world. By setting up global teams focussed on each required country, they can ensure that they have all of the appropriate parts of the supply chain and relevant functions involved to meet the specific country’s challenges. It allows them to set goals for meeting specific requirements and hold the teams accountable for delivery.
He also discussed some of the specific challenge areas that Teva are addressing around technology, organisation and development of the supply base.
How to implement Smart Product Protection and gain targeting visibility
Fabrice Equer, Business Development Director, SICPA
Fabrice presented on the latest developments from SICPA on overt and covert security features for product protection. This included colour shifting inks, tamper evidence seals, filter and machine readable protection and developments in how to use graphical security within 2dcodes.
Sustainable development in leaflet paper
Keith Rousell, International Sales Manager, Bollore Thin Papers
Bollore are 0ne of the leaders in thin paper for the pharmaceutical industry and Keith presented on the activities that they are undertaking to assure a sustainable approach to paper supply. This is a broad strategy from supply of sustainable timber, through energy supply and water and waste management. This allows them to certify the supply their products for their environmental impact.
What are our expectations for the Delegated Acts?
Christoph Krahenbuhl, EFPIA
Hans Bigalke, Deputy Head, EDQM
Christoph and Hans led a discussion on the impact of the FMD delegated acts. The discussion centred around the rules for products in and out of scope (the black and white lists) and the implications for Pharma companies.
It could be see that, like many types of new regulation¸ the detail of the regulations have still be to established as the rules are defined in local country legislation
Designing packaging around child safety and medication for the elderly
Stephen Wilkins, Chairman, Child Safe Packaging Group
Child safety is a key issue for pharmaceutical packaging. Stephen’s presentation covered the regulations, testing approach and issues associated with developing child safe packaging. He also discussed the issues faced by elderly patients trying to use child safe packaging, some of the testing undertaken with that group of patients and solutions that could be applied
The latest developments in Pack Design for Patient Safety
Eduardo Vidal Blanco, Device and Packaging expert, Novartis Pharma AG
Eduardo discussed aspects of packaging design that need to be considered when developing packaging for patient safety. He looked at the various guides and standards that have been developed and some of the solution that could be considered.
Introducing Track and Trace in the largest packaging and distribution plants in Turkey
Gianfranco Landolfi, Key Account Manager, Antares Vision
Gianfranco’s presentation covered and overview of the Antares track and trace solution and key learning points Antares gained from the implementation of serialisation with a number of customers in Turkey. These included the number of lines, suppliers and IT systems that had to be included, the different types and technologies of lines, the physical space required and how to optimise line performance.
Communication challenges in Labelling Changes
Mike Baird, Pharma Business Director, Matthews Brand Solutions
Ensuring artwork is right first time is an important topic to me and, in his presentation, Mike covered many of the communication issues they see from various clients that makes achieving right first time artwork a challenge. He shared his perspective and advice on how to improve the clarity of requirements to the artwork provider and how to build a better relationship between the requesters of change and the artwork team.
Packaging and Labelling on assessment for Formulary Inclusion – a Payer’s Perspective
Omar Ali, Formulary Development Pharmacist, Surrey and Sussex NHS Trust, UK
Omar is a pharmacist so is a user and buyer of the products we pack. His talk covered the implications of packaging design from the sharp end – its use in busy hospital activity. He showed examples of how poor packaging graphic design can have implications on the usability of the product by healthcare professionals, and how simple changes can aid error proofing.
Omar also explained how work done by the Helen Hamlyn Institute at the Royal College of Art on safer packaging design is being used by the UK NHS to support buying decisions to ensure patient safety is considered as part of the purchasing decision.
Ensuring the safety of your supply chain: Mass-serialisation and Tamper Verification features
Johannes Schoen, Senior Manager, Anti-counterfeiting, Boehringer Ingelhiem
Johannes presented on the activities BI have been doing on serialisation particularly with Turkey and the SecurPharm pilot in Germany.
Johannes also shared some of BIs thoughts on solutions for the tamper evidence requirements of FMD for both cartons and uncartoned bottles.
Get the most out of track and Trace: lessons learned from applying Turkish ITS and the German SecurPharm Pilot
Dirk Hendrik Kneusels, Commercial Director and Business Development, Laetus GmbH
Hendrik framed the learning they have gained from serialisation implementation in terms of the lean seven elements of waste. He looked at how you need to approach implementation of solutions in an appropriate way to minimise the impact of the seven elements of waste on packaging operations. He also looked at the timelines required to meet the regulations and some of the different capabilities required for the different legislative requirements. He had two clear messages – think carefully to avoid adversely impacting line efficiency, and if you haven’t started preparing yet, you need to start now…..
Case Study: Pharmaceutical Track and Trace System in Turkey
Taha Yayci, Consultant, Turkish Ministry of Health
Taha presented on the track and trace system in Turkey that he is responsible for. He covered the operation of the track and trace capability, learnings associated with its implementation, and the benefits that have been achieved both in patient safety and reimbursement fraud. The system has had such a significant impact in the country that its financial payback is estimated at about 18 hours.
How choosing the right paper can save you time and money
Marco Kutscha, General Manager, T.S.P Germany GmbH, Delfort Group
In his presentation, Marco explained the different measures applied to paper in terms of thickness, weight and opacity. He showed how different types of paper can demonstrate very different performances and that careful selection of the right grade and material can have significant benefit in the ability to handle and fold leaflets and the readability to the user.
Adopting Labelling Process for Global Supply: Driving Standardisation
Horst Kastrup, Senior Regulatory Advisor, MEDA Pharma
Different country legislative environments and their impact on packaging design, the challenges of implementing Braille on packaging and forthcoming regulatory requirements were the themes on Horst’s presentation. He highlighted how regulatory requirements can be a significant challenge to comply with and that careful pre-planning was essential to develop both packaging and process solutions.
Top Tips for Complexity Management
Andrew Love, VP Capability Development, Be4ward Ltd
I presented on the challenges of increasing packaging complexity and some approaches to address. The presentation can be viewed via the following link Andrew-Love. There is also an accompanying Top Tips booklet that is available from the Be4ward web-site at http://www.be4ward.org/?p=2022
Working to reduce the internet supply of falsified medicines
Jim Thomson, Chairman, EAASM
Jim presented a challenging topic on the issues associated with illegal on-line pharmacies and associated supply of falsified medicines. He shared a number of examples of how these sites operate and the implications on patient safety and confidence. He also outlined the work going on by multiple parties to bring control to the area and eliminate the practices currently occurring.
Tamper Evidence: Legal Aspects and Solutions
Andreas Brand, Product Manager, Baumer hhs GmbH
Andreas showed us a number of techniques for introducing tamper evidence on packaging components. As a clear requirement of the FMD, this is key area for packaging design and Andreas outlined the benefits of a number of different approaches to the issue.
Structured Debate: ESM and EDQM Developing the best possible model to meet the FMD
Hans Bigalke, Deputy Head, EDQM. John Chave, Secretary General, PGEU
Hans and John participated in a lively debate between ESM and EDQM on their respective approaches to serialisation and authentication in Europe. Whilst agreeing that patient safety was the paramount goal for both, the debate highlighted some of the differences in viewpoint between the two organisations. Whilst there is some convergence in requirements it was clear that there is some way to go before there is full agreement on a way forward, and in the meantime the two organisations will progress their own solutions.
Remaining Competitive in the Current Environment: Effectively Implementing New Technologies
Carolina Sanchez-Cespedes, Head of Packaging, Lilly S.A. Spain
Carolina presented on a range of activities that Lilly have undertaken at their factory in Spain to cope with increasing levels of packaging complexity and the subsequent impacts on efficiencies of their packaging facilities. She showed how a number of complimentary approaches were necessary to provide appropriate solutions.
A new Global Artwork Change Management Process and System
Massimo De Carlo, Global Supply Chain Quality Systems Manager, F. Hoffman- La Roche
Jochen Weisser, Project Lead, F. Hoffman- La Roche
The final presentation was by Massimo and Jochen on the artwork management process and system that Roche have implemented to improve quality and efficiency in their artwork change operation. Although it is relatively early days since they implemented, they are already seeing marked improvement in performance and are now considering how to roll the capabilities out further in their organisation.
Overall a stimulating and thought provoking two days, a big thank you to Anna, Sarah and the team at IQPC for another great conference.