Conference Day Two

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

9:00 AM - 9:05 AM Chairman’s Opening and Recap of Day One

9:05 AM - 9:50 AM Case Study: Taking Stock of Present Global UDI Conditions

  • Outline of current UDI status on a global scale for the diagnostic imaging business group within Philips and how this fits into the company and it's UDI strategy as a whole
  • Future preparations regarding MDR and European UDI system
  • What can device manufacturers do now, regardless of size, to properly prepare for UDI implementation in Europe and potentially the rest of the world?

9:50 AM - 10:35 AM Case Study – A Step by Step Guide to UDI Labelling Implementation

Melissa Finocchio, Sr. Director, Product Labeling & Documentation, bioMerieux
  • Initial planning stages and best practice planning methodologies with regards to UDI labeling project
  • Execution of UDI labeling projects – key personnel, responsibilities and timings
  • Potential pitfalls when embarking upon UDI labeling with a new team
  • Ensuring that senior management are bought in, in order to safe guard funding and support

Melissa Finocchio

Sr. Director, Product Labeling & Documentation
bioMerieux

10:35 AM - 11:10 AM Networking Coffee Break

11:10 AM - 11:55 AM Case Study – Successful Implementation of UDI in the US and Lessons Learnt

Dawn Fowler, Program Manager, UDI, Masimo
  • What to look for when reviewing regulations and legislation – what will affect you?
  • Key managerial and resource allocation considerations when implementing UDI
  • Developing a working system for UDI setup across the organisation
  • Common pitfalls encountered by device manufacturers in the USA and methods of avoiding these
  • Appling these lessons learned to UDI implementation elsewhere in the world

Dawn Fowler

Program Manager, UDI
Masimo

11:55 AM - 12:35 PM Case Study: The End User Perspective – How UDI Affects the Supply Chain Management for Practitioners

Hajo Reißmann, Head of Medical Supply Controlling, University Hospital Schleswig-Holstein

Hajo Reißmann

Head of Medical Supply Controlling
University Hospital Schleswig-Holstein

12:35 PM - 1:30 PM Networking Lunch

1:30 PM - NaN:NaN AM Case Study: Ensuring Data Integrity for Database Submissions

Mark Hoyle, UDI Global Lead, Teleflex
  • Case study of UDI implementation from a data perspective
  • Building data and information sharing capabilities and focusing upon preparations for global data synchronisation
  • Lessons learned from GUDID submissions and how to avoid them
  • Ensuring timely and accurate submission of data, alongside labelling
  • The current status of EUDAMED and how you can best prepare for data submissions now

Mark Hoyle

UDI Global Lead
Teleflex

2:15 PM - 3:15 PM Interactive Round Tables and Working Groups

Choose your area of interest for an extended of in depth discussion on a set topic, before reporting back to the rest of the room on your findings:
Roundtable A
Ensuring Data Preparation and Compliance – Further Discussions
Roundtable B
Implementing a Cross-Departmental ‘Special Project’ Team for UDI

Roundtable C
Developing the Global Information Standard for Medical Products
Roundtable D
The ‘Basic UDI’ Concept – Attempting a Definition

3:15 PM - 3:45 PM Networking Coffee Break

3:45 PM - 4:30 PM Case Study: Executing the Project – The challenges for the company

Thomas Krohn, Senior Compliance Specialist, Oticon A/S
  • Identify and translate requirements to company language
  • A case study of class ii UDI implementation in the USA
  • How can these be applied to future UDI implementation (e.g. in Europe)
  • Differences between small scale and large scale manufactures

Thomas Krohn

Senior Compliance Specialist
Oticon A/S

4:30 PM - 5:00 PM Interactive Session: Evaluation and Application of Learnings in Relation to UDIs – Where Are You?

  • Discussions around how far most companies are from being compliant and what is required in order to get there
  • What are the key departments of your business that will be affected by this? Considerations across:
  • Medical device manufacturers
  • Practitioners and hospitals
  • Universal next steps in order to ensure that all parties are closer to compliance when regulation takes effect

5:00 PM - 5:10 PM Chair’s Closing Remarks

Frank Pokrop, Director, Regulatory Affairs, BD

Frank Pokrop

Director, Regulatory Affairs
BD