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

Conference Day 2

9:15 am - 9:45 am Master Data Management Between Hospitals and Suppliers: Current and Future

  • Explore how UDI is used in the hospital and why it is important
• Benefit from a case study of the Scan4Safety Programme in University Hospitals Plymouth NHS Trust
•    Understand how master data is managed currently in the hospitals and how hospitals get the data from suppliers
•     Deep dive into how GDSN can improve a hospital’s master data and save significant time and money for both suppliers and hospitals

Lei Yu, Head of Supply Chain Operations at Oxford University Hospitals NHS Foundation Trust

Lei Yu

Head of Supply Chain Operations
Oxford University Hospitals NHS Foundation Trust

9:45 am - 10:15 am Scan4Safety using UDI and Master Data in a Clinical Environment

•Deep dive into the core enablers of Scan4Safety: GLN, GTIN, GSRN
•Learn about maximising the use of information, reviewing stock, decreasing holding, and increasing knowledge in inventory and product recall 
•Explore other benefits including patient tracking, electronic patient record, full vein to vein blood transfusion, Advanced Therapy and CAR-T Tracking
•Discover how to prepare hospitals for the future: building a digital hospital at Leeds Teaching Hospitals

Mark Songhurst, Project Manager - Scan4Safety at Leeds Teaching Hospitals NHS Trust

Mark Songhurst

Project Manager - Scan4Safety
Leeds Teaching Hospitals NHS Trust

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! 
Lei Yu, Head of Supply Chain Operations at Oxford University Hospitals NHS Foundation Trust

Lei Yu

Head of Supply Chain Operations
Oxford University Hospitals NHS Foundation Trust

Eric Bertorello, EMEA EDI and Digital Associate Director. at Zimmer Biomet

Eric Bertorello

EMEA EDI and Digital Associate Director.
Zimmer Biomet

Mark Songhurst, Project Manager - Scan4Safety at Leeds Teaching Hospitals NHS Trust

Mark Songhurst

Project Manager - Scan4Safety
Leeds Teaching Hospitals NHS Trust

Dr. Hajo Reißmann, Former Head of Medical Supply Controlling at University Medical Center Schleswig Holstein

Dr. Hajo Reißmann

Former Head of Medical Supply Controlling
University Medical Center Schleswig Holstein

11:25 am - 11:55 am How Can We Move Towards Standardisation in a Very Complex Environment?

•Gain insight into the constraints related to medical devices 
•Consider the different expectations of multiple stakeholders
•Analyse the non-standard environment

Eric Bertorello, EMEA EDI and Digital Associate Director. at Zimmer Biomet

Eric Bertorello

EMEA EDI and Digital Associate Director.
Zimmer Biomet

11:55 am - 12:25 pm Master Data Management Systems: Identifying the Right Solution for your Business

•Explore internal vs. external solutions, including the advantages and disadvantages of each 
•Delve into managing multiple data requirement types within MDM systems (regulatory and logistics), and discover what to include and what not to
•Discuss maintaining and implementing connectivity with unique global data repositories

Dawn Fowler, Director UDI and Master Data Management at Masimo

Dawn Fowler

Director UDI and Master Data Management
Masimo

12:25 pm - 12:55 pm Main Challenges, Actions Taken and Lessons Learned as a Manufacturer, Importer and Distributor of Medical Devices Placed in the EU Market

•Compare EU UDI verification and validation, as well as risk management strategies
•Analyse EU UDI registration and CE certification processes
•Unpack EU UDI technical documentation and resource issues
•Scrutinise the opportunities for standardisation in the medical device sector on the use of UDIs

Jorge Figueira, QA Manager at Pasante Healthcare Limited

Jorge Figueira

QA Manager
Pasante Healthcare Limited

1:55 pm - 2:25 pm Considerations for Implementation of Basic UDI – DI

•Consider associated data elements
•Deep dive into the assignment decision matrix 
•Uncover the documents to reference Basic UDI-DI

Jackie Elkin, Global Process Owner Standard Product Identification at Medtronic

Jackie Elkin

Global Process Owner Standard Product Identification
Medtronic

2:25 pm - 2:55 pm UDI Compliant Manufacturer's QMS: Four Layers Approach

•Ensure efficient process execution to be ready for FDA, MDR and South Korea all at once
•Discover the impact on the QMS through UDI spreading and learn about the 4 layer approach which includes the Regulatory Specification Layer, UDI Life Cycle Layer, QMS Process Layer and Rules Layer
•Benefit from two case studies, covering the direct marking decision making process and the change management process for UDI data

Florian Haase, Project Manager - UDI/EUDAMED & Operations Data Analytics at Biotronik

Florian Haase

Project Manager - UDI/EUDAMED & Operations Data Analytics
Biotronik

2:55 pm - 3:25 pm Practical Usage of UDI on Software as a Medical Device

•Get to grips with good practice of labelling on software
•Discover how to handle legacy software products
•Case Study: How to tackle future updates or modifications to marketed products in relation to UDI

Laurent Van Linden, QARA Manager Europe & International at Agfa Healthcare

Laurent Van Linden

QARA Manager Europe & International
Agfa Healthcare

3:55 pm - 4:25 pm Case Study: A Serialisation and UDI Comparison

•Consider how pharmaceutical serialisation can aid the practical implementation of UDI
•Explore the transferrable skills that can be applied to UDI 

Antoine Tracq, Head of Commercial Logistics & Serialization at Galderma

Antoine Tracq

Head of Commercial Logistics & Serialization
Galderma

4:25 pm - 4:55 pm UDI Challenges for Consumer Healthcare Products

•Explore the challenges and implications of UDI for a Consumer Healthcare Company 
•Consider the hurdles of a Global company with a very mixed portfolio
•Navigate Global UDI requirements where exemptions are key 

Alex Adams, Global Regulatory Affairs UDI Lead at Reckitt Benckiser

Alex Adams

Global Regulatory Affairs UDI Lead
Reckitt Benckiser