What we learned from TRACKTS 2017
With more than 160 participants from pharmaceutical companies and contract manufacturers, industry associations, packaging and serialization solution providers, Trackts ! 2017 was a great opportunity to network, exchange views and experiences and discuss the latest trends, industry news and regulatory updates around pharmaceutical serialization, track&trace and supply chain efficiency.
Serialization and track & trace implementation
Subjects covered during plenary sessions, presentations and roundtables were as diverse as building business strategy and developing a future-proof and cost effective T&T implementation, creating value beyond compliance by, among other things, making use of Big Data, Cloud serialization and traceability solutions, integration of a track & trace functionality into existing systems, tamper-evident and intelligent packaging and more.
Key take-aways were the importance of communication and harmonization but also the potential value beyond compliance of a well implemented and thought-out T&T strategy.
Serialization affects nearly all aspects of a business
Bottom-line of most presentations and discussions was that communication is key and should not be underestimated, whether internal communication or exchange with supply chain partners. This came across clearly during the use cases presented by those who are already ahead in their serialization implementation. Given that serialization affects nearly all aspects of a business, representatives of all concerned departments should be included in implementation planning and roll-out to avoid misunderstandings and to be prepared to invest the time needed for proper roll-out.
A maximum of harmonization and standardization
All concerned parties should aim for a maximum of harmonization and standardization; whether in terms of implementation and roll-out across lines and sites to save time; or data and exchange formats to facilitate mutual understanding and onboarding processes.
Value beyond serialization compliance
To reap value beyond compliance and be prepared as best they can, marketing authorization holders and drug manufacturers might want to consider going beyond the bare minimum when it comes to FMD requirements. Thus, aggregation could bring benefits all along the supply chain, i.e. facilitating logistic processes or making recalls easier. MAHs should also consider collecting and storing serialization data themselves beginning February 2019 in the event that the National Medicines Verification Systems (NMVS) in some of their markets are not ready. Thus, they will be able to communicate their serialization data via the EU hub to the relevant national system as soon as the system in question is ready.
Trackts conference plenary session