The Healthcare Distribution Alliance (HDA, formerly HDMA) will host its annual Traceability Seminar November 9–11, 2016, at the Renaissance Washington, DC Downtown Hotel. The seminar will host supply chain leaders—including distributors, manufacturers, pharmacists, third-party logistics providers — as well as federal/state regulators to discuss upcoming milestones and lessons learned as they continue to implement the Drug Supply Chain Security Act (DSCSA).
FDA’s Connie Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity and Recalls, will deliver a keynote presentation on the DSCSA guidance the agency has provided, how FDA is preparing for the implementation milestones and the agency’s expectations for the pharmaceutical supply chain as it steadily approaches the 2023 completion date.
The seminar will include a presentation of the results from HDA’s Pilot Study for Saleable Returns, conducted earlier this year to further understand the operational impact of the DSCSA’s 2019 requirements for distributors to verify serialized saleable returns from customers. Industry experts from various manufacturers and distributors conducted a study of nine real-life scenarios that would allow the pharmaceutical supply chain to comply with the requirements related to the 2019. HDA will outline the workable solutions that were identified through the pilot project.
Additional sessions will touch on meeting global traceability requirements, perspectives from the retail/pharmacy community and technology experts on their priorities for implementation.