THE ONLY EUROPEAN CONFERENCE DEDICATED TO GLOBAL UDI COMPLIANCE AND WIDER INDUSTRY IMPLICATIONS
EUDAMED goes live May 2020, US FDA UDI is already going strong and many other countries around the world have their own independent plans and timelines. UDIs have officially gone international, the deadlines are rapidly approaching, and in the EU there is no grace period.
Are you ready for global UDI compliance?
Many medical device manufacturers are looking for clarity from regulators on what exactly is required of them, while still trying to interpret what guidance has already been released. One thing is clear though -
UDI projects need to be starting now, to have any hope of meeting the expected timelines - despite not having all the information yet.
The greatest challenge of all is sure to be the sheer scale of building and maintaining a database that is capable of efficiently cleansing and validating
UDI data while being able to submit to multiple different international datapools with their own requirements and standards - effective master data management with a view to global
UDI compliance is truly an enormous task.
The
European UDI Forum seeks to help provide answers to many of these challenges by uniting all the key stakeholders in the healthcare ecosystem - device manufacturers, healthcare providers, regulators, classification organisations,
UDI agencies, data standards bodies and technology solution providers. There is truly no other meeting like it in Europe; if you're facing UDI compliance, you should be at this forum.
What Will be Covered?
- European MDR UDI regulatory updates
- UDI requirements and timelines around the world
- Global harmonisation efforts
- Practical case studies and lessons from manufacturer UDI projects
- Master data management approaches and case studies
- Data standards and interoperability (GS1 and GDSN, GMDN, HIBCC, ICCBBA, SNOMED, HL7)
- Hospital UDI experiences and how to best leverage the data
Who is The Forum For?
- Medical device manufacturers, including;
-UDI Project leaders & members
-Regulatory Affairs
-Quality
-Labelling & packaging
-IT
-Supply chain - Regulators & notified bodies
- Healthcare providers & practitioners
- UDI Solution Providers
2019's Speakers and Facilitators include:
- Terrie Reed, Senior Advisor for UDI Adoption, US Food & Drug Administration (FDA)
- Tania Pearson, Senior Program Manager, Medtronic
- Salvatore Scalzo, Policy and Legal Officer, European Commission
- Tom Jones, Program Director - UDI, Supply Chain Visibility, Johnson & Johnson
- Ulrike Kreysa, Vice President Healthcare, GS1
- Dawn Fowler, Director, UDI/Master Data Management, Masimo
- Karen Conway, Vice President, Healthcare Value, GHX
- Jay Crowley, Vice President and UDI Practice Lead, USDM
- Azzam Al Othman, Head, Products Registration Support, Medical Devices Sector, Saudi Food & Drug Authority
- Vincent Callan, Director of Facilities Management, St. James's Hospital
- Kevin Taylor, Project Manager, UDI & Supply Chain Visibility, Johnson & Johnson
- Behnaz Minaei, CDRH-Informatics Team, FDA
- Jenny Young, Contract Project Manager MDR, ConvaTec
- Fabien Roy, Counsel, Hogan Lovells
- Dennis Black, Director, e-Business, Solutions Group, BD
- Tommy Roy Rosholt, UDI Project Manager | NPI Project Manager, Oticon
- Paul Ashford, Executive Director, ICCBBA
- Dr. Hajo Reismann, Head of Medical Supply Controlling, Universitatsklinikum Schleswig-Holstein
- Mark Wasmuth, CEO, The Global Medical Device Nomenclature (GMDN)
- Christian Hay, Senior Consultant Healthcare, GS1
Please fill in your name and email to receive the Conference Agenda of this event.
Pre-Conference Workshop Day - 23 April 2019
Conference Day One - 24 April 2019
Conference Day Two - 25 April 2019
Venue
Pullman Brussels Centre Midi Hotel
Place Victor Horta 1, 1060
Bruxelles, Brussels, Belgium
Venue
Pullman Brussels Centre Midi HotelPlace Victor Horta 1
1060 Bruxelles, Brussels
Belgium
Website:
https://www.accorhotels.com/gb/hotel-7431-pullman-brussels-centre-midi/index.shtmlPhone: +32 2 528 98 00
AccommodationTravel and accommodation are not included in the conference fee; however we have put together a HotelMap that displays discounted accommodation for hotels in the area near to UDIs & Traceability for Medical Devices 2019. The map displays live availability and allows you to book directly with each hotel:
https://www.HotelMap.com/pro/MQJVZPlease note: We will never recommend, approve or appoint any third party rooming service to act on our behalf. Please be extremely wary if you are approached by any such companies. We will always endeavour to negotiate the best available rates for you so please use the HotelMap link provided; this shows live availability and rates for all hotels in the area and allows you to book directly with the hotel of your choice within your budget.
