Table of Contents
WASHINGTON — The Healthcare Distribution Alliance (HDA) will host its annual Traceability Seminar two months early, on August 29–31, 2023, in Washington, D.C. The earlier date reflects the urgency surrounding the upcoming Drug Supply Chain Security Act (DSCSA) implementation deadline and the critical need to share information and solutions.
HDA has hosted the Traceability Seminar for ten years. In 2023, the event will bring together healthcare supply chain leaders, Food and Drug Administration (FDA) and other stakeholders to hold important conversations as the industry learns more about DSCSA implementation. Since the law’s passage in 2013, the DSCSA has fundamentally changed the way pharmaceutical products and their associated data move in tandem through the supply chain while increasing safety and security for patients. After the DSCSA’s final deadline of November 27, 2023, supply chain trading partners will be required to provide transaction data along with serialized product upon a change of ownership.
“With the pharmaceutical supply chain in a critical work period, the Traceability Seminar will provide an opportunity for industry stakeholders to share their experiences and challenges and, ultimately, align on outstanding compliance issues,” said Perry Fri, EVP, Industry Relations, Membership and Education, HDA. “In our role as a convener on all things DSCSA, HDA looks forward to hosting educational offerings to help supply chain partners forge ahead as the November deadline comes into view.”
The seminar will include:
- A presentation from the FDA highlighting DSCSA regulatory updates;
- A discussion on HDA’s proposed phased implementation of the DSCSA;
- Information on how to apply for an FDA waiver, exception or exemption from the law’s provisions;
- Real-world recommendations on exceptions handling and mitigating data errors;
- Critical GS1 updates on systems implementation guides; and,
- An opportunity to meet with numerous technology provider sponsors during table-top exhibits.
Notable speakers will include industry experts from McKesson Corporation, AmerisourceBergen and Cardinal Health, in addition to insights from Connie Jung, Senior Advisor for Policy, FDA; Tracy Nasarenko, Sr. Director, Community Engagement, GS1 U.S and more.
HDA has been active on issues surrounding pharmaceutical traceability for approximately two decades. With the pharmaceutical supply chain in an uneven state of readiness for the November deadline, the association wrote a June 2 letter to FDA recommending that the DSCSA’s final requirements be implemented in phases to build capacity and stabilize the law’s complex processes. The phased approach would include a limited FDA grant of enforcement discretion to certain DSCSA requirements and trading partners, with full implementation phased in over a period of two years and would ensure the supply chain continues without disruptions to patient care.
In addition to the Traceability Seminar, a webinar series is being held this summer. These sessions are also focused on preparation for DSCSA implementation. The upcoming July 27 webinar will discuss HDA’s recommended phased approach.
Additional information on the Traceability Seminar is available here. Media registration is complimentary.
