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DSCSA Conference Agenda

(as of August 1, 2022 – subject to change.)

 


   Day 1

 

Opening Keynote: State of DSCSA

Speaker: Connie Jung, RPh, PhD, Senior Advisor for Policy, U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Compliance/Office of Drug Security, Integrity, and Response

GS1 US: Platform for Interoperability Framework

Delivered by Tracy Nasarenko, Senior Director Community Engagement, GS1 US and panel of pharmaceutical manufacturers, distributors, wholesalers, dispensers, and technology providers to be announced.

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.

 

Enabling Auto ID Technologies: Reducing the Burden & The Current Applications

Delivered by AIM North America and a panel of technology providers and current DSCSA stakeholders

Auto ID Technologies have been around for many years, enabling many industry applications. This session will provide an historical snapshot of examples over time, discuss how auto ID technologies reduce the burden of compliance, and provide insight into the current DSCSA applications driving authenticity and a safe, secure supply chain.

 

 

Dispenser Requirements and Preparation

Speakers: Eric Marshall, Executive Director, Partnership for DSCSA Governance (PDG); Steve Postal, JD, Director of Policy and Regulatory Affairs, National Community Pharmacists Association (NCPA)

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.

 

Closing a Key Gap in DSCSA Compliance with Credentialing

Speakers: Bob Celeste, Founder, Center for Supply Chain Studies; David Kessler, President, Legisym, LLC; Georg Jürgens, Manager Industry Solutions, Spherity; Ben Taylor, CEO, LedgerDomain

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. Attendees will further learn more about OCI, how we can help, and meet some of our members.

 

Informal Networking Gathering

   Day 2

 

PDG Blueprint for Interoperability

Delivered by Eric Marshall, Executive Director, Partnership for DSCSA Governance (PDG)

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.

 

DSCSA Interoperability Data Simulation and Case Study

Delivered by Eric Marshall, Executive Director, Partnership for DSCSA Governance (PDG); Bob Celeste, Founder, Center for Supply Chain Studies

See how DSCSA will be shared and used to investigate suspect and illegitimate drug products through this live data simulation. Panelists will demonstrate the use of DSCSA data to support product verification and tracing, and participants will have the opportunity to observe the simulation and engage in detailed discussion about the capabilities and limitations of the DSCSA enhanced systems and processes.

 

DSCSA Implementation: The Good, the Bad and the Ugly

Facilitated by: Jillanne Schulte Wall, J.D., Senior Director, Health and Regulatory Policy, Office of Government Relations, ASHP along with members from large hospital system; a small rural hospital; and a mid-sized regional system.

This panel will share where they currently are with DSCSA implementation, what challenges they may have encountered, bright spots in their processes, lessons learned, and what is next for DSCSA compliance (this may include the process for quarantining suspect product, how white-bagging/brown-bagging intersect with DSCSA requirements, etc.).

 

The Forward March: Collaboratively Moving Towards the 2023 Compliance Deadline

Representatives from the US FDA, AIM North America, GS1 US, PDG, PDSA, NCPDP, NABP, HIDA, NCPA, OCI, Center for Supply Chain Studies, and ASHP will share ongoing projects/activities, the next steps and supporting resources to move cohesively towards the compliance deadline in 2023.

 

 

 

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