11 - 12 November, 2020
Online Event
Conference Day 2
12:10 pm - 12:15 pm
Chairman's Opening Remarks
12:15 pm - 12:50 pm
Smith and Nephew’s Journey to UDI Compliance
Mark East -
Global UDI Program Manager,
Smith & Nephew
- Discuss key challenges and practical solutions to achieving UDI compliance
- Ask the question: What does the future hold for UDI
12:50 pm - 1:30 pm
Use of GS1 Standards for Successful UDI Implementation
Sylvia Reingardt -
Senior Manager Healthcare,
GS1
•Deep dive into UDI and GS1
•Uncover the role of GS1 as UDI issuing agency/entity
•Analyse UDI worldwide: challenge and opportunities
1:30 pm - 1:50 pm
Coffee Break
1:50 pm - 2:40 pm
Panel Discussion: Does it Make Sense for EUDAMED to be Used as a Source for Master Data for Healthcare Providers?
Dr. Hajo Reißmann -
Former Head of Medical Supply Controlling,
University Medical Center Schleswig Holstein
Myriam Dahani - Regulatory Affairs Manager, Novomed Group
John Wilkinson - Chair, Global Medical Devices Nomenclature Agency
Deep dive into the advantages and disadvantages of using EUDAMED as a source of master data for healthcare providers, by hearing the perspectives of hospitals as well as medical device manufactures. Prepare for a fiery conversation!
Dr. Hajo Reißmann
Former Head of Medical Supply ControllingUniversity Medical Center Schleswig Holstein
2:40 pm - 3:15 pm
Case Study: How to master the global UDI Challenge
Patrick Pfau -
CEO & Co-Founder,
projektraum36
- Explore the challenges of achieving global UDI Compliance at Enterprise Scale
- Discuss what strategic considerations need to be made before establishing a global UDI setup
- Consider the relevance of an flexible and extensible framework capable of handling multiple agencies to achieve worldwide UDI compliance
- Analyse the transition plan to establish an global UDI program on the example of current UDI projects for FDA GUDID and EC EUDAMED
- Deep dive into the main phases of an UDI project and how the phases of multiple projects merge into an ongoing UDI program cycle to define your global UDI setup
3:15 pm - 3:50 pm
UDI Requirements for the Vigilance Reporting Process
Dr. Fatima Sanfourche -
Senior Manager RA/QA Compliance for Medical Devices and eHealth,
Bayer
- Explore major changes of vigilance systems due to the MDR requirements
- Discuss how these regulations introduce an EU identification system for medical devices based on a Unique Device Identifier
- Consider the role of UDI in the traceability of the device during the vigilance reporting process
- Analyse the challenges of the implementation of the new electronic reporting process
- Deep dive into how UDI will enhance the effectiveness of post-market safety-related activities for devices
3:50 pm - 4:00 pm
Coffee Break
4:00 pm - 4:35 pm
Live from the USA: FDA Perspective on UDI System Progress
Erin Quencer -
Regulatory Health Scientist,
FDA
- Explore updates to UDI implementation in the USA
- Delve into using AccessGUDID
- Consider lessons learned
4:35 pm - 5:15 pm
Realizing Master Data Management: Collaboration and Innovation in UDI implementation
Terrie Reed -
Principal Consultant and Director Partner Relationships,
Reed McCullough, LLC and Symmetric Health Solutions
Joseph D'Amore - Manager, Master Data Management, Boston Medical Center - Boston, MA
- Current status of US UDI implementation
- Role and benefits of US UDI Collaborative Communities
- Re-imagine Master Data Management
- Applying innovation to scanning
- Matching results to UDI-DI and data sources
- Automating feedback to improve data quality
- Health System Case Study
Terrie Reed
Principal Consultant and Director Partner RelationshipsReed McCullough, LLC and Symmetric Health Solutions
5:15 pm - 5:50 pm
From Disaster to Demand Planning: UDI Delivers Value to Providers and Suppliers Today and Tomorrow
Karen Conway -
Vice President, Healthcare Value,
GHX
· Discuss how the pandemic is changing the nature of conversations between suppliers and providers, with greater focus on how to strengthen supply chain resiliency, enable demand planning and support bi-directional inventory visibility
· Examine how each of these outcomes can provide value across the entire supply chain, and have raised awareness of the value of UDIs beyond regulatory compliance
· Exploring how broader adoption of UDIs can support future pandemic and emergency response alongside how use of standard identifiers can help participants to increase efficiencies, lower costs, improve patient safety and support more strategic provider-supplier relationships.
