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September 6-8, 2022
Hilton Baltimore | Baltimore, MD USA
September 6-8, 2022
Hilton Baltimore | Baltimore, MD USA
 

UDI Conference Agenda

(as of May 16, 2022 – subject to change)

   September 6, 2022

12:00pm — 6:00pm

UDI Conference Registration Open

12:00pm — 5:00pm

Pre-Conference Workshop –

GS1 Standards in Support of UDI and the Future of Healthcare

 

(Co-located program delivered by GS1 US. Separate registration required-link coming soon.)

Attendees will be introduced to the basics of the U.S. FDA UDI Rule and to those GS1 Standards that can be used to address certain aspects such as unique product identification and using GS1 Barcodes. The workshop will also discuss the basics of managing high-quality data, the industry’s migration to 2D barcodes, and how GS1 Standards support global harmonization for medical devices.

 

Registration Information Coming Soon!

12:00pm — 6:00pm

AIM Summit

(Co-located program delivered by AIM North America. Separate registration required-link coming soon.).

Registration Information Coming Soon!


   September 7, 2022

7:30am — 5:30pm

Registration Open

 

8:00am — 9:00am

Coffee / Networking

9:00am — 10:15am

The Panorama: The Evolving Global UDI Landscape

Speaker: Jay Crowley, Vice President Medical Device Solutions and Services
Panelists to be announced

Jay Crowley
USDM
Vice President Medical Device Solutions and Services

As global regulators, purchasers and other stakeholders begin to develop and implement country or regulator-specific UDI or UDI-like systems – they are not only trying to address device identification – but also support specific national or local concerns (e.g., counterfeits, traceability, cost-control/reimbursement). These new regulatory, commercial, and patient-safety use-cases create novel and complex challenges for device manufacturers, who now must establish, maintain and submit the ever-growing (and changing) broad set of global device attribute information to these various robust global systems, processes and stakeholders. This session will review the current global climate and outline the trends and the direction of the international UDI activities to address the question of how companies might manage distribution at a UDI level.

10:15am — 10:45am

Exhibits / Networking

Exhibit Hall open 10:00am – 5:30pm

Complete Your PRIZE CARD!

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10:45am — 12:45pm

Getting Specific on the EU MDR

The EU MDR regulation includes significant UDI requirements, some of which are new and different from the US regulation.  We will cover these differences and highlight major new challenges, allowing ample time for audience discussion. The session will cover:·

  • The UDI Application
  • Basic UDI-DI (and Master UDI-DI)
  • UDI Data Attributes for EUDAMED
  • Understanding the Transition Provisions, Re-Certification & Reclassification Components of MDR
  • Role of other Economic Operators (authorized reps, importers distributors)
  • Systems and procedure packs
  • QMS implicationsAudience Q&A

 

12:45pm — 2:15pm

Exhibits / Lunch

Complete Your PRIZE CARD!

2:15pm — 3:30pm

The Elephant in the Room: UDI for Non-Sterile Implants

This lively conversation will discuss the current lack of requirements for non-sterile implants in the U.S. market which contradicts the EU MDR Requirements. This issue has been rearing its head time and time again and is being pushed even further with hospitals sharing their concerns. This panel will talk through the current activities, identify where we are seeing gaping needs, review the impacts, and outline some future steps that the industry is suggesting in order to address this issue.

3:30m — 4:00pm

Exhibits / Break

Complete Your PRIZE CARD!

4:00pm — 5:15pm

Facilitated Conversation on Hot Topics / Issues

Speaker: Dennis Black, UDI Program Director, Global Regulatory Affairs

Panelists to be announced

Dennis Black
Global Regulatory Affairs
UDI Program Director,

New DI triggers; lack of harmonization on data attributes & definitions; list of values; confusion on what needs to be done, when globally; short implementation periods for some regulations; migration to 2D; and more will be discussed. Bring your issues / hot topics to share in this audience-engaged session facilitated by industry thought leaders.

6:00pm — 7:30pm

Informal Networking Gathering

   September 8, 2022

8:30am — 5:15pm

Registration Open

8:30am — 9:30am

Exhibits, Networking & Coffee – Make the most of your time by visiting with the UDI Exhibitors, networking and getting your Prize Card completed! Exhibit Hall open 8:00am – 2:30pm

9:00am — 9:45am

UDI: Unlocking Value-Based Healthcare

Speaker: Karen Conway, Vice President, Healthcare Value, GHX; Natalia Wilson, MD MPH, Adjunct Faculty, Arizona State University | College of Health Solutions; Adjunct Assistant Professor, Mayo Clinic Alix School of Medicine

Karen Conway
GHX
Vice President, Healthcare Value
Natalia Wilson, MD MPH

MD MPH, Adjunct Faculty, Arizona State University | College of Health Solutions; Adjunct Assistant Professor, Mayo Clinic Alix School of Medicine

This level-setting, thought-inspiring session will explore how UDI regulations fit in the global movement toward value-based healthcare.  Understanding the bigger picture helps answer questions around WHY,  HOW and WHAT to do to leverage your investments in UDI compliance and adoption to meet evolving market demands, and position your organization for success in a healthcare system that rewards the delivery of outcomes that matter to patients relative to the cost to achieve them.

9:45am — 10:30am

Data Management

There are many new, expanding, and evolving global medical device regulations – many of them focused on improving our visibility into and control over the global supply chain – and the understanding of the safety and effectiveness of devices over their lifecycle. This – in combination with the digital transformation of healthcare – is challenging many medical device manufacturers in new ways. There is an urgent need to collect, manage, submit, and (importantly) maintain an expanding list of data attributes to a growing number of regulatory (and commercial) databases globally. Concurrently, more customers and other stakeholders (including trading partners, researchers, hospitals, clinicians, patients, payors) are requesting more information about the devices they purchase and use. This session will discuss ways for device manufacturers to identify the best way to manage data attributes across their various regulatory, commercial, catalog, sales, and distribution systems.

10:30am — 11:00am

Exhibits / Networking

11:00am — 12:30pm

Working Through the Chaos to Build a Sustainable Framework

You will gain an understanding of why and how to envision a robust strategic approach to establishing a foundation for addressing the unfolding UDI-related requirements around the world. Knowing the critical pillars and how to work with industry stakeholders (health-care providers, researchers, patients, purchasers, insurers, and regulators) will help achieve the shared goals of improving device safety/effectiveness, healthcare quality/patient safety, and reducing risks and healthcare costs. The appropriate initial development, maintenance and re-use of information is central to establishing and supporting a sustainable framework.

12:30pm — 2:00pm

Luncheon & Exhibits / Networking – last chance to get your Prize Card completed!

2:00pm — 2:45pm

Recall Management: The UDI Impacts

Moderator: Mike Schiller, Senior Director, American Hospital Association, Association for Health Care Resource & Materials Management (AHRMM)
Panelists to be announced

Mike Schiller
American Hospital Association, Association for Health Care Resource & Materials Management
Senior Director

The UDI Impacts on Recall Management Work Group, a part of AHRMM’s Learning UDI Community (LUC), will review their recommended practices reports that analyzes the barriers and highlights the benefits to patient safety and key stakeholder groups when utilizing the UDI throughout the recall process, underscoring mutual areas for improvement in the safety and efficacy of the recall process. Additional resources, such as a comprehensive Regulatory Resource Guide and the Recall Time & Cost Collection Tool will be shared.

2:45pm — 3:30pm

Session to be Announced

3:30pm — 3:45pm

Stretch Break

3:45pm — 4:45pm

UDI Community: Current Activities & Future Landscape for UDI

Moderator: Patti Blessing, UDI Work Group Chair, AIM North America

Panelists: Mike Schiller, Senior Director, American Hospital Association, Association for Health Care Resource & Materials Management; Linda Rouse-O’Neill, Director, Healthcare Supply Chain Collaborative, Health Industry Distributors Association (invited); Eric Marshall, Executive Director, Partnership for DSCSA Governance (PDG), Indira Konduri, U.S. Food and Drug Administration (invited)

Mike Schiller
American Hospital Association, Association for Health Care Resource & Materials Management
Senior Director
Linda Rouse-O’Neill (invited)
Healthcare Supply Chain Collaborative, Health Industry Distributors Association
Director
Eric Marshall
Partnership for DSCSA Governance (PDG)
Executive Director
Indira Konduri (invited)
U.S. Food & Drug Administration

This session will provide industry reports from the leading trade organizations on the current work being conducted on UDI-related activities covering multiple stakeholder positions. You will hear what industry organizations are teaching and learning about UDI adoption, and programs being implementation through their member constituents representing the healthcare providers, medical device manufacturers, distributor organizations, and others. Gain an understanding of the strategic UDI priorities creating the collaborative communities both here in the United States as well as other countries for the benefit of global trade and device evaluation. Understand how these organizations are supporting each other in a cooperative community fashion, and how you, too, can become involved.

 

4:45pm — 5:00pm

Conference Wrap-Up and Prize Winners Announced (MUST be present to win!).

 

 

Join us September 6-8, 2022 in Baltimore!
Register Today!
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