Dawn FowlerProgram Manager, UDI
UDI execution is nothing new for the majority of medical device companies that have been implementing the FDA guidelines and regulations for the past four or more years. With the recent publication of the European Medical Device Regulation, this FDA lead legislation has been adopted into the European environment, with a challenging European timeline for compliance.
For companies undertaking their UDI programs for the first time, or for those looking to adjust their strategy towards global compliance, it is important to be proactive in your adoption and compliance strategy.
This interactive session will take you through, step by step, easily implemented techniques and simple principles which will enable you to format a clear implementation strategy and align this with broader company goals and objectives.
What Will be Covered
- Approach regulatory interpretation at both a global and local level
- Unite the team – bringing together your key stakeholders to align UDI implementation with company objectives to ensure the generation of value beyond compliance
- Outline your data strategy – approaching master data implementation as a means of generating greater product insight and driving global regulatory and trade partner compliance
- Put your building blocks in place early – what do we know about EU requirements already, and how can you create a flexible implementation plan to cope with adjustments and greater clarification
This session will provide you with an understanding of the principles and techniques for approaching UDI implementation in light of EU regulations while ensuring consideration of global regulatory and trade partner requirements.
The practical and hands on approach will allow delegates to generate strategies to be proactive in their UDI implementation as well as learn and understand multiple approaches for efficient implementation. Delegates will have open discussion to leverage learnings from each other’s experiences and walk away with information to begin planning for moving forward with their UDI programmes.
- Utilise all of the different forms of device meta-data that the UDI implementation requires to generate an holistic view of your medical device
- Maximise these data sources to effectively segment patient populations as a means of mapping out, and identifying, any device quality issues
- Analyse your data sources to drive device analysis as the basis for ongoing device development