August 10, 2018
By Perry Fri, HDA and the HDA Research Foundation — As the summer winds down, HDA is hard at work planning our 2018 Traceability Seminar, which will take place three weeks earlier, on October 17–19 at the Renaissance Washington, DC Downtown Hotel (http://bit.ly/2MwTuhd). As the industry passes the halfway mark for Drug Supply Chain Security Act (DSCSA) implementation, our 2018 agenda leverages HDA and our members’ unique expertise to help fellow stakeholders answer critical questions while planning for the multiple milestones ahead.
The first full day will feature an update from FDA’s Ilisa Bernstein, Deputy Director of the Office of Compliance, Center for Drug Evaluation and Research. Given the Agency’s many activities in the past year, this will be an opportunity for attendees to hear directly from FDA on upcoming milestones, as well as their expectations for the pharmaceutical supply chain.
The seminar also will feature the results of the HDA Research Foundation’s annual Serialization Readiness Survey, providing a chance for supply chain stakeholders to benchmark their company’s progress against their peers (see the 2017 executive summary). The survey captures a snapshot of what percentage of serialized product wholesale distributors can anticipate entering the supply chain when FDA enforcement discretion ends on November 27, 2018. Importantly, this survey also includes repackagers, who share the 2018 deadline.
A significant part of this year’s DSCSA implementation work has focused on the industry’s efforts to get the Verification Router Service (VRS) up and running. The seminar will feature VRS testing results, including a panel discussion on lessons learned, as well as an interactive session on items to consider and how to connect to the network.
Meanwhile, while much of the work to date has been done between manufacturers and distributors, dispensers also have been making progress. A dispenser panel will shine a light on the work of these companies, and the challenges they have faced during the implementation process. Additionally, a discussion on 2023 will present how each industry segment will comply with the ultimate goal of end-to-end serialization.
Finally, no DSCSA-related seminar would be complete without a presentation on the standards the industry is using to enable compliance and interoperability. GS1 US has launched many initiatives and work groups this year focused on adoption of standards, like the GLN or EPCIS conformance testing. Peter Sturtevant, Sr. Director Industry Development – Pharmaceuticals, GS1 US, will provide an overview of the work group efforts.
In addition to the educational programming, our networking breaks will not only provide face-to-face time with peers and DSCSA experts, but also a chance to peruse solutions through our table-top exhibits. (Interested in exhibiting? Learn more here.)
Speakers and sessions continue to be confirmed — stay tuned to our daily schedule for the latest updates.
New this Year: Interactive, Workshop-Style Sessions
You asked, and we listened. Based on your feedback, HDA will be providing an opportunity to workshop key issues in small-group discussions. These interactive, workshop-style sessions will convene attendees to talk to their peers about their current operational challenges, in discussions facilitated by industry experts. Highlights from each of the small groups will be shared at the end.
Help us choose our discussion topics! Your feedback will help HDA determine the small-group topics. To vote on your preferred topic, fill out our Traceability 2018 Workshop Topic Poll.
Your Go-To Event for DSCSA-Related Education
From legislative concept, through enactment and now during the collaborative work of implementation, HDA has been your trusted partner for DSCSA-related information. And through our role as a convener, no other organization brings together the diverse group of stakeholders to tackle the toughest issues faced through the implementation process. We expect this year’s event to sell out, so start planning now to be counted among our attendees.
To register, visit the HDA website.
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.