The FDA’s November 27, 2023 compliance deadline for interoperable electronic exchange, verification & tracing of drug supply products at the package level is right around the corner!
Together with our industry partners, OCI will host a virtual conference dedicated to DSCSA over two half-days on Nov 17 & 18. Attendance will be free of charge.
Agenda
Nov 17 - Regulatory Background & Authentication
10.00-10.05 ET ☆ Opening by OCI
10.05-11.20 ET ☆ Connie Jung, RPh, PhD - Opening Keynote: State of DSCSA & National Drug Code Proposed Rule
FDA will provide implementation updates on the Drug Supply Chain Security Act (DSCSA) including review of recent guidances for industry to prepare for enhanced drug distribution security requirements that go into effect in November 2023. In addition, FDA will review 2 proposed rules about 1) national licensure of wholesale drug distributors and third-party logistics providers and 2) format changes to the national drug code (NDC).
11.20-11.25 ET ☆ Break
11.25-12.55 ET ☆ OCI - Credentials: Your Key to the DSCSA Network
In this interactive session the Open Credentialing Initiative (OCI) will introduce the concept and practical application of electronic credentials. Attendees will explore their use in the context of DSCSA and learn how to obtain credentials to enable timely compliance with the DSCSA Authorized Trading Partner (ATP) requirements.
12.55-13.00 ET ☆ Break
13.00-13.30 ET ☆ Expert Panel - Dispenser Concerns
Nov 18 - Moving Product & Interoperability
10.00-11.00 ET ☆ Tracy Nasarenko, Scott Mooney, MBA, Elizabeth Waldorf, Mike Mazur - GS1 US: Platform for Interoperability Framework
Be prepared to engage in a lively conversation that will address:
Overview of the GS1 Standards, specifically the EPCIS standard, a critical component to successfully exchange data under the DSCSA.
The available resources such as the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability.
Lessons learned from the onboarding of Manufacturers; what was expected versus unexpected; what can be shared and leveraged with other trading partners as they prepare for DSCSA; what gaps still exist?
What challenges are Wholesalers experiencing as they have a unique perspective of being in the middle of the supply chain.
What communication is needed between Wholesalers/Distributors, Dispensers, and Solution Providers?
Common questions on how Dispensers can meet the DSCSA 2023 requirements. Breakdown of communication needs, methods, and expectations.
11.00-11.05 ET ☆ Break
11.05-11.35 ET ☆ Eric Marshall - PDG Blueprint for Interoperability
PDG is a collaborative forum of 70 industry members and an FDA public-private partnership dedicated to developing, advancing, and sustaining an effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the U.S. PDG’s Foundational Blueprint for Interoperability provides a vision for interoperability across the supply chain, including TI data exchange, product identifier verification, and tracing. This session will provide participants an overview of the PDG Blueprint and how participants can use it to set a course toward interoperability.
11.35-11.40 ET ☆ Break
11.40-12.55 ET ☆ Eric Marshall, Steve Postal, JD, Max Peoples, RPh - Dispenser Requirements and Preparation
This session will provide an overview of the DSCSA requirements that apply to or impact Dispensers and explore key questions facing Dispensers for 2023, including:
An overview of existing process requirements under the DSCSA.
An overview of the new electronic interoperability requirements that take effect November 27, 2023.
Managing and reconciling data upon product receipt: when and where to scan.
Suspect product investigation requirements.
Impact on pharmacy-to-pharmacy transactions.
The role of solution providers and supplier in supporting compliance.
The role and value of DSCSA data in pharmacy operations, patient care, and dispensing.
DSCSA-relevant SOP for dispensers
12.55-13.00 ET ☆ Break
13.00-13.30 ET ☆ OCI Closing Panel - Key Take-aways & Next Steps
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