Tuesday, April 23rd, 2019
9:00 AM WORKSHOP A2 - What Comes Next? Meeting Commercial UDI Requirements and Preparing for Emerging UDI Regulations
Who’s it for? Open to all levels. Designed for participants that have already mastered the UDI basics and/or are meeting the existing FDA UDI regulations.
Required/Prerequisite Knowledge: Basic understanding of UDI
What do I need to bring? Knowledge of your company’s strategy for meeting commercial UDI Requirements and emerging UDI regulations.
Many device manufacturers are successfully moving towards complying with FDA UDI regulations and are on their way to complying with EU MDR/IVDR UDI requirements. In addition, there are several commercial UDI requests/requirements that need to be considered.
There are also several other countries that are moving UDI regulations. With the recognition of emerging UDI regulations and new market requirements, UDI is no longer a project but a long term process.
This session will focus on commercial UDI requirements. It will include the expectations on labeling, associated data, and where applicable, commercial expectations. It will also highlight the emerging market requirements.
The session will also include lessons learned from Healthcare Providers during the initial FDA UDI implementation efforts.
What Will be Covered?
- NHS Scan4Safety overview
- AHRMM UDI Learning Community
- Commercial requirements that exceed or differ from regulator requirements
- Emerging UDI regulations
- Implementation lessons learned to date
Who’s it for? Open to all levels. Required/Prerequisite Knowledge: Basic understanding and/or previous experience with UDI
What do I need to bring? Nothing
Although many manufacturers have finished, or are finishing, compliance with the US FDA regulations, there are new UDI requirements developing internationally. With global recognition and development of international requirements, UDI is no longer a single project, but a long-term process.
This session will focus on UDI/Master Data Management processes, systems and standardisation to gain global UDI compliance. It is targeted towards those with prior UDI experience, or beginners continuing from Workshop A1.
What Will be Covered?
- Development of governance and strategy building on “Source of Truth”
- Implementation of an Internal/External centralised data source
- Integration strategies for new regulatory data mandates
- Lessons learned to date
- Understanding of new global UDI & Master Data requirements
- Current understanding of FDA and EU MDR requirements for UDI
- Leveraging UDI data internally
Conference Day 2
Thursday, April 25th, 2019