OR WAIT null SECS
© 2025 MJH Life Sciences™ and Pharmaceutical Commerce - Biopharma Business News, Market Insights. All rights reserved.
Industry leaders—from manufacturers, distributors, and dispensers—reported increased preparedness for compliance, with discussions shifting toward exception management, governance, and enforcement readiness, note Ullrich Mayeski of GS1 US and Mark Karhoff of Ten Count Consulting.
In a video interview with Pharma Commerce, Ullrich Mayeski, community engagement director of health with GS1 US, and Mark Karhoff, principal consultant with Ten Count Consulting, discuss how last month’s HDA Traceability Seminar received positive feedback from attendees, who emphasized both the quality of its organization and the timeliness of its content. The event, held annually, was noted for effectively addressing the current challenges facing the pharmaceutical supply chain. Participants highlighted that one of the greatest strengths of the seminar lies in its diverse audience, which brings together manufacturers, distributors, dispensers, solution providers, and professionals from varying organizational levels. This diversity facilitates meaningful conversations, both within sessions and informally, helping stakeholders compare challenges, share strategies, and build valuable relationships across the industry.
According to attendees, this year’s seminar differed from previous ones in tone, shifting toward a stronger sense of confidence and readiness. Manufacturers, in particular, appear to have made significant progress in providing data and resolving technical issues. Distributors also displayed greater assurance in their preparedness for the approaching regulatory requirements. While inbound processes seem relatively stable, outbound operations continue to present challenges, particularly in ensuring compliance on the dispenser side. Attendees observed that dispensers still benefit from certain exemptions, especially regarding the receiving of electronic data, which provides them additional time and flexibility.
The broader industry discussion is now less about uncertainty and more about refining readiness for enforcement. Attendees pointed to three major themes gaining traction: exception management, governance, and compliance execution. Exception management focuses on how companies will address inevitable discrepancies or system errors. Governance relates to setting consistent policies and practices across supply chain partners to ensure compliance. Overall, the event reflected an encouraging trend: the pharmaceutical supply chain is moving closer to readiness for the upcoming traceability enforcement deadlines, with conversations now centered on fine-tuning systems rather than questioning their feasibility.
In separate conversations, the speakers also dive into panels they participated in at the conference; industry’s preparedness for DSCSA enforcement; best practices stakeholders should adopt to ensure secure, end-to-end traceability and interoperability; and much more.
A transcript of their conversation with PC can be found below.
PC: What were your thoughts on the HDA’s Traceability Seminar?
Mayeski: It was a really good conference. HDA has put this on annually for some period of time now, but generally, the HDA events are really well organized. The content is very relevant for the time period that the industry is in.
I think the other thing that's nice about these conferences is you bring in folks from all kinds of different areas within the supply chain. You've got manufacturers, distributors, dispensers, solution providers, and then folks from various levels within the organizations. A lot of the conversations that get generated during the conference—in and outside of the sessions—is really relevant for industry, one, for folks to take a pulse on how they're doing and if some of the questions that they're asking are similar to some of the questions that are being asked. And just to build relationships and thing—so they do a really nice job of that.
Karhoff: Definitely a good conference. I feel like the tone is changing from last year, and I think we're getting a lot more confidence that the manufacturers, the majority, are ready and providing data, and that they're working through issues. Even with the distributors, it felt like there's a little bit more confidence now for the date, actually this week, that they're ready.
Related Content: