21 - 23 April, 2020 | Novotel Berlin Am Tiergarten, Berlin, Germany

Conference Day 1

9:00 am - 9:15 am People Bingo: Interactive Speed Networking

Be ready to meet your peers and share best practices. You will have several 2 minute conversations to enable you to introduce yourself and add to your contact pool. There is a prize in it for the winner so get networking!
 
Please Share:
1. Who you are
2. The scope of your job role
3. What you plan to achieve from attending this event
4. Your #1 challenge

9:15 am - 9:50 am Don’t Do UDI Alone: The Power of Collaborative Communities

·         Question why successful UDI compliance and adoption require collaboration among manufacturers, healthcare providers, and many other stakeholders
·         Discuss the role of hospitals and healthcare systems in ensuring ongoing MDR compliance for manufacturers
·         Learn how to effectively engage stakeholders in collaborative communities
·         Explore key learnings from existing learning communities 
Karen Conway, Vice President, Healthcare Value at GHX

Karen Conway

Vice President, Healthcare Value
GHX

Terrie Reed, Principal Consultant at Reed McCullough, LLC

Terrie Reed

Principal Consultant
Reed McCullough, LLC

9:50 am - 10:25 am UDI and Implants: Challenges and Implications Across the Medical Device Ecosystem

·         Compare implant related UDI requirements in the EU and US (similarities and differences)
·         Analyse the challenges of identifying implants for regulatory compliance and evidence generation
·         Scrutinise best practices and lessons learned
·         Evaluate the impact of global harmonisation of UDI on implant clinical evidence
Karen Conway, Vice President, Healthcare Value at GHX

Karen Conway

Vice President, Healthcare Value
GHX

Terrie Reed, Principal Consultant at Reed McCullough, LLC

Terrie Reed

Principal Consultant
Reed McCullough, LLC

Whilst the delay to the EUDAMED deadline will tempt manufacturers to breathe a sigh of relief and slow down their preparations, it is critical that this additional time is used wisely to ensure manufactures are compliant with MDR by the new launch date of May 2022. Gain insights into how manufacturers can use the delay wisely and develop an effective strategy for publishing data to EUDAMED.  
Karen Conway, Vice President, Healthcare Value at GHX

Karen Conway

Vice President, Healthcare Value
GHX

Pasi Kemppainen, Global Traceability Lead at Santen

Pasi Kemppainen

Global Traceability Lead
Santen

Dawn Fowler, Director UDI and Master Data Management at Masimo

Dawn Fowler

Director UDI and Master Data Management
Masimo

•Deep dive into the key steps in formalising and implementing the global UDI strategy
•Discuss master data challenges and processes
•Explore global UDI implementation aspects and system landscapes
•Gain insight into operationalising the global UDI roll-out

Pasi Kemppainen, Global Traceability Lead at Santen

Pasi Kemppainen

Global Traceability Lead
Santen

Myriam Dahani, Senior Regulatory Affairs Specialist Medical Devices at Santen

Myriam Dahani

Senior Regulatory Affairs Specialist Medical Devices
Santen

12:05 pm - 12:35 pm Use of GS1 Standards for Successful UDI Implementation


•Deep dive into UDI and GS1
•Uncover the role of GS1 as UDI issuing agency/entity
•Analyse UDI worldwide: challenge and opportunities

Géraldine Lissalde-Bonnet, Director Public Policy- Healthcare at GS1

Géraldine Lissalde-Bonnet

Director Public Policy- Healthcare
GS1

1:35 pm - 2:05 pm Live from the USA: FDA Perspective on UDI System Progress


- Explore updates to UDI implementation in the USA
- Delve into using AccessGUDID 
- Consider lessons learned 

Erin Quencer, Regulatory Health Scientist at FDA

Erin Quencer

Regulatory Health Scientist
FDA

2:05 pm - 2:35 pm Smith and Nephew’s Journey to UDI Compliance

•Benefit from a complete end-to-end outline of Smith and Nephew’s journey to UDI compliance 
•Discuss key challenges and practical solutions to achieving UDI compliance
•Ask the question: What does the future hold for UDI?

Mark East, Global UDI Program Manager at Smith & Nephew

Mark East

Global UDI Program Manager
Smith & Nephew

2:35 pm - 3:05 pm UDI Requirements for the Vigilance Reporting Process

  • 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

Dr. Fatima Sanfourche, Deputy Director Medical Device Vigilance, Global Pharmacovigilance at Bayer

Dr. Fatima Sanfourche

Deputy Director Medical Device Vigilance, Global Pharmacovigilance
Bayer

3:05 pm - 3:35 pm Why is UDI’s Impact on Hospitals Important to Manufacturers?

•Discuss improving labelling: should hospitals measure the impact?
•Question hospital master data: better quality? Completeness? Source?
•Delve into UDI and electronic patient records

Christian Hay, Senior Consultant - Healthcare at GS1

Christian Hay

Senior Consultant - Healthcare
GS1

4:05 pm - 4:45 pm UDI and Implant Card Considerations

•Review the implant card by connecting the dots between MDR articles and the MDCG guidance document 
•Deep dive into simplified EMDN nomenclature terms
•Consider UDI attributes of the implant card

Roger Peterson, Manager Global Labelling Systems at Arthrex

Roger Peterson

Manager Global Labelling Systems
Arthrex

4:35 pm - 5:05 pm Practical Implementation and Challenges From an Industry Point of View

•Discuss the challenges of practically implementing UDI 
•Gain insight into the many opportunities UDI offers 
•Explore the implementation steps via practical examples 

Heinrich Martens, Director Regulatory Affairs & QA at Fresenius Kabi

Heinrich Martens

Director Regulatory Affairs & QA
Fresenius Kabi

5:05 pm - 5:45 pm Interactive Roundtable Discussions


The best strategies are formed through expert collaboration! Break off into small groups and join forces with your peers in these interactive roundtable discussions. Choose one of the topics below, and get stuck into the debate.

•Implant Register
•Early Stage Implementation
•Procedure Packs
•Combination Products 
•Working with Stakeholders: MedTech Companies, Hospitals and Governments 

Stephen Roan, Sr. Director, Portfolio Data & Standards Compliance, at Smith & Nephew

Stephen Roan

Sr. Director, Portfolio Data & Standards Compliance,
Smith & Nephew