How to Ensure Reliable and Seamless Management, Sharing and Reporting of Serialization Data, the presentation will be given by Pavel Lotkov, Director of Product Management.
With EU FMD serialisation deadlines approaching in February 2019 and enforcement of the US DSCSA scheduled for November 2018, comprehensive serialisation efforts are in full swing on both sides of the Atlantic.
With the timeframe dwindling for ensuring sufficient infrastructure at the enterprise level and throughout the supply chain, far-reaching level 4 systems are uniquely positioned to deliver mandatory data sharing at various touchpoints.
Part of Lotkov’s discussion will focus on Adents Prodigi, the company’s signature cloud based level 4 solution.
Adents Prodigi centrally manages regulatory requirements mandated in the pharmaceutical industry, allowing pharmaceutical companies and CMOs to take advantage of the massive amounts of data generated during the serialisation, and the track and trace process.
In addition to offering compliance with incrementally complex regulations, Adents Prodigi opens up new horizons beyond regulatory compliance in terms of data analysis, machine learning tools and additional capabilities through third party solutions.
Adents Prodigi also offers a certified gateway to the European Hub, having passed a series of thorough tests with the European Medicines Verification Organization.
Per the EU FMD, reporting to the European Hub will entail generating and managing serialisation data compliant with each target market.
The certification makes Adents an official On-Boarding Partner Gateway Provider (OBP) authorised to sign on behalf of Marketing Authorisation Holders and transfer their unique identifiers and related information to the European Hub.
In essence, Adents can now legally vouch for its customers concerning serialisation compliance.
Adents has acquired a reputation for solutions enabling customers to comply with current and future serialisation mandates with unsurpassed speed, limited machine downtime and minimal investment in new equipment or infrastructure.
“While extensive amounts of time and resources have been expended on line-site implementations, it is now critical to connect the dots with sufficient infrastructure both at the enterprise level and along the ensuing supply chain,” said Christophe Devins, CEO of Adents.
“An urgent need exists for solutions capable of addressing the evolutionary nature of regulatory requirements as well as utilising this data for metrics-driven business operation improvements.”