Opening Session

Welcome Remarks

Perry L. Fri, Executive Vice President, Industry Relations, Membership & Education and COO, HDA Research Foundation, Healthcare Distribution Alliance

FDA Overview and Update

Sponsored by  

FDA has had another active year on DSCSA implementation, including issuing guidances, holding meetings, and conducting a pilot program. At the same time, the Agency is actively responding to unprecedented issues, such as COVID-19, that have required high-priority attention.

This session will provide an opportunity to hear directly from the Agency on upcoming milestones, additional Agency actions as well as their expectations for the pharmaceutical supply chain.

Leigh Verbois, Director of the Office of Drug Security, Integrity and Response , U.S. Food and Drug Administration

Overview of Recent and Upcoming DSCSA Requirements

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FDA and the supply chain are continuing efforts to meet applicable and upcoming DSCSA requirements taking effect between now and November 2023, when the statute’s full Traceability requirements are reached. HDA will provide an overview of recent and upcoming DSCSA milestones, as well as FDA’s implementing guidances, regulations and policies (both proposed and final, including those that are not specific to DSCSA, but nevertheless involve the DSCSA’s requirements). This session also will describe the DSCSA’s requirements effective on November 27, 2023, with some suggestions for where we go from here when establishing policies to meet the DSCSA’s end point.

Tish E. Pahl, Principal, Olsson Frank Weeda Terman Matz PC

Virtual Happy Hour/Networking

Traceability Roundtables

Attendees will have the opportunity to discuss current operational issues associated with traceability implementation. Choose a topic of interest, rotate through the virtual tables (breakout rooms), and convene with peers in small roundtable discussions, hosted by industry experts. Topics include: EPCIS, VRS Verification/Qualification, Return Verification Failures, Dispenser Perspective, Getting Manufacturers Ready, and Using the GS1 System of Standards.

 

*Be prepared to turn on your camera and/or microphone to join in the discussions. 

	Jeffery W. Denton, V.P., Global Secure Supply Chain, AmerisourceBergen Corporation
	Gary Lerner, Managing Director, BrandSure, LLC
	Scott A. Mooney, Vice President, Distribution Operations, McKesson Corporation
	Leon Nevers, Director, Procurement and Business Development, H-E-B
	Michael Rowe, Serialization Services Manager, Two Labs, LLC
	Peter F. Sturtevant, Senior Director, Community Engagement, GS1 US

Solution Provider Lunch Presentations