Conference Day 2

8:30 AM - 9:00 AM Registration and Welcome Coffee

9:00 AM - 9:10 AM Chairman's Opening Address

9:10 AM - 9:50 AM Creating Alignment Between The Regulatory, The Supply Chain And The Customer

Dennis Black, Director, e-Business, Solutions Group, BD
- Understand value beyond compliance – UDI implementation beyond regulatory requirements
- Consider the needs of the customer – how to approach UDI whilst ensuring customer usability
- Look at UDIs as a means of driving supply chain transformation

Dennis Black

Director, e-Business, Solutions Group

9:50 AM - 10:30 AM Translating The MDR – What We Know So Far

Céline Bourguignon, Director Global Regulatory Policy, Johnson & Johnson
- Current shift in global focus – from FDA to European MDR
- Discuss an implementation timeline of regulatory changes for new device developments, ongoing device developments and legacy devices
- Understand the requirements – what can you be doing now to move beyond tick box regulatory compliance for your UDI implementation

Céline Bourguignon

Director Global Regulatory Policy
Johnson & Johnson

10:30 AM - 11:00 AM Networking Coffee Break

11:00 AM - 11:40 AM Starting With Your Data – The Importance Of Data Integrity For Master Data Management And Database Submissions

Jenny Gough, UDI and GS1 Specialist, MedTech Europe
- Understand the relevance of data integrity and importance of their role in protecting the safety of the patient
- Define data integrity in the real world – what does it mean for your company process
- Build data and information sharing capabilities and focusing upon preparations for global data synchronisation

Jenny Gough

UDI and GS1 Specialist
MedTech Europe

11:40 AM - 12:10 PM Embracing UDI to Create a More Connected Digital Labelling Enterprise that Transforms the Workplace Environment and Simplifies MDR Compliance

Neil Gleghorn, Founder & CEO, Kallik
  • Why connected labelling systems and processes are essential pre-requisites to minimising disruption and enabling greater productivity across extended supply chains
  • Simplifying the transition toward eLabelling and eIFUs whilst maintaining alignment across both printed and electronic labelling
  • Enabling transparency of content and approvals processes across the enterprise to ensure enhanced compliance with MDR

Neil Gleghorn

Founder & CEO

12:10 PM - 12:50 PM UDI Implementation From A Medium Sized Company Perspective

Cédric Reinert, Shared Service Project Manager, E.M.S. Electro Medical Systems S.A
- Weigh up the cost of implementation as a Medium Sized Company
- Create a framework for lean implementation to manage budgetary restrictions
- Understand the implications of implementation on product development timelines and regulatory compliance

Cédric Reinert

Shared Service Project Manager
E.M.S. Electro Medical Systems S.A

12:50 PM - 1:50 PM Networking Lunch

1:50 PM - 2:30 PM Leveraging UDI Frameworks To Enhance Medical Device Quality And Security

Dawn Fowler, Program Manager, UDI, Masimo
- Utilise all of the different forms of device meta-data that the UDI implementation requires to generate an holistic view of your medical device
- Maximise these data sources to effectively segment patient populations as a means of mapping out, and identifying, any device quality issues
- Analyse your data sources to drive device analysis as the basis for ongoing device development

Dawn Fowler

Program Manager, UDI

2:30 PM - 3:10 PM Protecting your Product: Brand Protection and Anti- Counterfeiting Through IPM Utilisation

Mariacarmela Vozzo, IPM Manager, World Customs Organisation
- Understand the role of the global customs network in Medical Device supply and traceability
- Utilise the World Customs Organisation’s IPM program to identify counterfeit goods and empower your anti-counterfeiting strategy
- Examine the benefits of connecting manufacturers product portfolios with IPMs authentication and track&trace solutions

Mariacarmela Vozzo

IPM Manager
World Customs Organisation

3:10 PM - 3:40 PM Networking Coffee Break

3:40 PM - 4:20 PM UDI As A Catalyst For Building Process Excellence

Martin S. Walter, Project Lead Consultant UDI, BIOTRONIK
- Look beyond the UDI – how can you use your UDI as a driver for broader logistical and regulatory change
- Examine the shift to global compliance – implementing a strategy for global UDI adoption beyond basic compliance
- Generate value from UDI – building an implementation plan to support broader strategic development and process excellence

Martin S. Walter

Project Lead Consultant UDI

4:20 PM - 5:00 PM Summative Panel – Developing A Flexible And Global Implementation Strategy

- Outline the current benefits that have been seen from UDI adoption from the perspective of all stakeholders
- Discuss the long term goals past implementation for all stakeholders
- Analyse the broader environment – how can UDI be leveraged as a driver to device development?
- Examine the global approach – can we create a set of requirements at the global level or does compliance need to be addressed through flexible national approaches?

5:00 PM - 5:15 PM Chairman's Closing Address

5:15 PM - 5:30 PM Closing Questions and Close of Conference Day 2