In the first part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, shares his overall thoughts on this year’s DMC.
In a video interview with Pharma Commerce, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, describes how the HDA Distribution Management Conference (DMC) covers a broad spectrum of topics within the pharmaceutical supply chain, with a special focus on current regulatory and operational challenges. One of the major topics at this year’s conference was the Drug Supply Chain Security Act (DSCSA), which prompted several discussions and roundtable sessions.
The DSCSA has significant implications for the pharmaceutical supply chain, especially in terms of enhancing traceability, safety, and efficiency in drug distribution. At the DMC, various presentations and dedicated roundtable sessions were held to address its impact, compliance requirements, and the ongoing industry adaptations necessary to meet its mandates. These discussions provided insight into the challenges and solutions that stakeholders in the pharmaceutical supply chain are encountering as they work to ensure compliance with DSCSA regulations.
Overall, the DMC served as an important platform for exploring the evolving landscape of drug supply chain security, with the DSCSA at the forefront of many conversations. Given its complexity and importance, the conference highlighted the need for continued collaboration and knowledge sharing among industry professionals to navigate the regulatory landscape effectively.
Rowe also comments on where he believes industry stands in terms of DSCSA readiness; some of the supply chain disruptions that stakeholders are reporting; and much more.
A transcript of his conversation with PC can be found below.
PC: What were your overall thoughts on this year’s HDA Distribution Management Conference?
Rowe: The HDA Distribution Management Conference, or the DMC—as it's commonly referred to—is a pretty wide-ranging conference in that it covers a lot of topics in the pharmaceutical supply chain. In particular, I'll probably talk and comment more around the different conversations and roundtables that were happening around the DSCSA, or the Drug Supply Chain Security Act.
There was a whole series of presentations, and like I said, roundtables, where it was focused just on the DSCSA, given its prominence and its impact on the pharmaceutical supply chain.
Overall, the conference went well. Definitely new things that were being discussed, but also some familiar topics that we've talked a lot about in years past, so happy to dive into some of the details. I think the biggest highlight for me was more regulatory engagement from both the FDA and the state regulator side.