Is your team evaluating UDI regulatory submissions for EU and other regions?
All the complexity around UDI regulatory (and commercial) requirements across the globe create serious challenges for product data management. When considering what’s at stake, a discussion with those who have taken on the ‘build’ challenge and learned some hard lessons is a good place to start.
In this informative presentation, hear some wisdom and explore all the options when it comes to UDI submissions for FDA, EU and other global regulators. The featured speakers each have a long tenure in the UDI solutions environment. From the start of the first FDA UDI mandate back in 2014 to the imminent EU UDI regulations, they have experienced the highs and lows of resolving the known and unknown in UDI data management and submissions.
Here’s a short excerpt of the presentation:
Review these key topics:
- The global UDI landscape – EU is just the next domino to fall in this game
- Hear about the challenges and considerations for building your own system
- What does it take to build and maintain a system for the long haul?
- Resource and budget implications – initial and ongoing
- Review the key risks of going with a vendor solution-are they really risks?
Of interest to:
- IT professionals
- Software Development professionals
- Product Information Managers
- Regulatory and compliance officers
- Quality control and quality systems officers
- Data management and statistics personnel
- Manufacturing directors and supervisors
To access the entire presentation, please let us know who you are. Thanks in advance! We hope you and your team find the content valuable.
Comments or questions? email us: MedDevice@ReedTech.com