Webinar: the blueprint to DSCSA-2023 readiness

The final step of the 10-year implementation the US-Drug Security and Supply Chain mandate (Title II of the Drug Quality and Security Act, DQSA) will come into force on 27th November 2023. It will be the final step in establishing an electronic, interoperable system to identify and trace prescription drugs that are distributed in the United States. This will be both end to end and at item level, from manufacturing through to dispensing.

This has major implications for the pharmaceutical manufacturers (MAHs) in terms of responsibility to identify and connect to their downstream supply chain stakeholders and also to be able to respond to verification queries and exceptions management process.

Excellis Europe, part of Excellis Health Solutions, are holding a webinar on the 29th March on DSCSA-2023 readiness. The webinar will focus on finalising the blueprint to compliance: 

• DSCSA, the last mile (final stretch/ timeline)
• Roles in the supply chain and responsibilities
• What do you really need for 2023? Compliance Simplified!
• Best Practices
• Q&A

Excellis Europe perceive, having worked with 200+ customers, that the phased implementation over 10 years, and the various ‘enforcement holidays’ have detracted from the significant challenge that compliance readiness for the final step of DSCSA presents. Having achieved compliance with earlier milestones or demanding regulations such as the EU-FMD will, unfortunately, not guarantee readiness for the November 2023 US requirements.

The global team of experts, including Christoph Krähenbühl, Frederic Menardo and Chris Stickel will focus on successful implementation for the US DSCSA-2023. They will explain how compliance with earlier DSCSA milestones or requirements such as EU-FMD can provide a solid basis for the November 2023 US compliance but will also identifying areas that require significant additional attention and effort.

As Greg Cathcart, CEO of Excellis Health Solutions says: “Most pharma companies think they are ready for US DSCSA-2023. In our experience, however, they seriously underestimate the remaining challenge. When we start working with companies, we almost always find that there are many missing elements that pose a substantial risk for successful compliance for them, and in fact, all in the pharma supply chain.”

Registration for the free webinar is open until 9am GMT, 10am Europe, 8am ET at https://register.gotowebinar.com/register/191856412419637334?utm_campaign=LSP510%3A+DIA+Europe&utm_medium=social_organic&utm_source=LinkedIn with the team going live one hour later.