Registration |Grand Ballroom Registration Desk

Networking Reception and Table-Top Exhibits |Renaissance Ballroom

Registration |Grand Ballroom Registration Desk

Networking Breakfast and Table-Top Exhibits |Renaissance Ballroom

Traceability Seminar Opening Remarks |Grand Ballroom

 

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

FDA Overview and Update |Grand Ballroom

FDA has issued a record number of guidances in draft or final form, as well as held a number of public meetings over the last year on DSCSA implementation. This session will provide an opportunity to hear directly from the Agency on upcoming DSCSA milestones, as well as their expectations for the pharmaceutical supply chain.

Ilisa B.G. Bernstein, JD,PharmD, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Networking Break and Table-Top Exhibits |Renaissance Ballroom

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Verification Router Service (VRS) Update |Grand Ballroom

Since 2016, HDA has convened industry and solution providers to develop the technical specifications necessary to build a Verification Router Service (VRS) network to comply with the 2019 saleable returns requirement.  In this interactive session, VRS testing participants will discuss what the network is, share what they have learned through the process to date and planned testing activities, what to consider as companies set up their system to connect to the VRS network, how and when to connect, and critical success factors. Attendees will have the opportunity to share their experiences and provide feedback through facilitated discussions and polling.

	David Colombo, Director, Life Sciences Advisory Services, KPMG, LLP
	Matt Sample, VP, Manufacturing Operations, AmerisourceBergen Corporation
	Allison Sheldon, Senior Manager, Business Technology, Pfizer Inc.

Networking Luncheon and Table-Top Exhibits |Renaissance Ballroom

Panel Discussion: HDA Perspective on FDA Guidance |Grand Ballroom

FDA has had an active year, releasing a variety of guidance documents and holding three public meetings on DSCSA implementation. Panelists will review the key highlights from these activities and share their perspective on implications for compliance.

	Anita T. Ducca, Senior Vice President, Regulatory Affairs, Healthcare Distribution Alliance
	Tish E. Pahl, Principal, Olsson Frank Weeda Terman Matz PC
	Brian P. Waldman, Esq. MBA, Partner, Arent Fox LLP

A Vision for 2023 |Grand Ballroom

As the supply chain reaches the halfway point between the DSCSA’s enactment and its endpoint, more attention is being paid to its ultimate goals. At the 2017–2018 FDA public meetings, stakeholders caught a glimpse of what the Agency, and other industry stakeholders, are anticipating for 2023. Panelists will provide perspectives from each sector of the supply chain on how they plan to meet the 2023 requirements.

	Perry L. Fri, Executive Vice President, Industry Relations, Membership & Education and COO, HDA Research Foundation, Healthcare Distribution Alliance
	Andrew Meyer, Traceability Lead / Senior Systems Analyst, Mutual Wholesale Drug Company
	Scott A. Mooney, Vice President, Distribution Operations, McKesson Corporation
	Arthi Nagaraj, Specialist, Supply Chain Processes, Sanofi US

Networking Break and Table-Top Exhibits |Renaissance Ballroom

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Dispenser Panel |Grand Ballroom

Panelists from the retail/pharmacy community will share their current thinking, approaches and challenges regarding the implementation of DSCSA. Topics to be addressed will include the structure of, and planning toward, a 2023 system; cost concerns; scanning and hardware upgrades across the dispensing community; communication strategies regarding packaging and bar code changes; and how dispensers report issues to FDA and upstream to suppliers.

	David Aguero, Manager, Medication Systems and Informatics, St. Jude Children's Research Hospital
	Ronald N. Bone, HDA Consultant, Ronald N. Bone Consulting LLC
	Michele V. Davidson, R.Ph, Sr. Manager, Pharmacy Technical Standards Development & Policy, Walgreens

Wrap-Up Discussion |Grand Ballroom

Networking Reception and Table-Top Exhibits |Renaissance Ballroom

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Registration |Grand Ballroom Registration Desk

Networking Breakfast and Table-Top Exhibits |Renaissance Ballroom

Adoption of Standards – GS1 |Grand Ballroom

GS1 continues to work on DSCSA readiness. Over the past year, the organization has launched several work groups focusing on developing standards or guidelines on how to use GS1 standards for compliance — from bar code assessments to GLN enumeration and EPCIS conformance testing. This presentation will provide an overview of key items under development and resources for industry.

Peter F. Sturtevant, Senior Director, Industry Engagement, GS1 US

Traceability Implementation Workshops |Grand Ballroom

Attendees will have the opportunity to discuss current operational challenges associated with traceability implementation. Convene with peers in small discussions, moderated by industry experts. Highlights from the discussions will be shared at the end of the session.

Take Workshop Topic Poll Here.  

	Reid Harvey Graves, Sr. Consultant Serialization, Sanofi US
	Carey Hoffman, Senior Manager, Logistics & Distribution, Sunovion Pharmaceuticals Inc.