15th - 18th May, 2018 | Amsterdam, The Netherlands

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White Papers

Data Complexities with the EU UDI Regime

A selection of experts have highlighted one key hurdle the market should brace for: data management with the EU UDI regime. Due to this area being expected to differ from the FDA’s GUDID process quite sharply in some places. With the MDR due to come into effect in a few years time, Pharma IQ gains insight on the forecasted data complexities attached to the EU’s UDI gameplan.

Filling The Gaps In Your UDI Strategy

Following the demand for increased accountability and traceability with medical devices to safeguard patient safety, manufacturers must meet the expectation to bring printing, labelling technologies and master data management up to compliance standards. This will involve developing a UDI corporate strategy and policy for all business units and departments.

On the road to meeting compliance deadlines and executing a UDI project one key step will be pinpointing any gaps between existing supply chain systems to UDI requirements. This will involve analysing the supply chain process, transit issues, the mechanics of recalls and reporting on a UDI compliant product and whether the expected benefits are achieved. Then redesigning and integrating management of product labelling and packaging to enable regulatory compliance. With this large task in mind, we spoke to a couple of experts on the subject of filling the gaps within a UDI strategy. Find out more here.

Exclusive Content

How can organisations make their supply chain more efficient by digitalising processes?

In the context of an increasingly competitive medical device market, implementing the upcoming European Unique Device Identifier will require considerable investment and strategic planning for many organisations. Ahead of the UDIs & Traceability for Medical Devices Conference, Pharma IQ spoke with Graham Francis, Channel Marketing Manager at Kallik to discuss the role of labelling digitalisation across the supply chain and how this can improve efficiency and visibility; moving beyond compliance to drive broader company improvement.

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