ON DEMAND WEBINAR
Duration: 1 hour​

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In recent years the global regulatory requirements have continued to evolve in many areas, with new interests in a particular area of focus – the Unique Device Identification (UDI). Whilst at a strategic level the global regulators are aligned in recognizing the need to enhance the traceability of supply of medical devices to and through the global markets, the operational reality has seen the beginnings of some level of divergence across countries.

Whilst regulations often stipulate UDI as a requirement, the data submissions around UDI requirements vary from country to country. The implementation of such UDI regulations can vary with country specific requirements, data structure definitions and other political & economic factors creating additional commercial considerations that begin to mandate what type of UDI solution/ label is required. In response to all this complexity the instant reaction is “we need a UDI solution” but what exactly is the type of solution that is needed and how should UDI requirements above those stipulated by country health authority regulators be handled? This webinar is designed to walk you through:

• Demystifying global UDI requirements, definitions and challenges across important markets
• Considerations and complexities in designing systems for UDI
• UDI workflows across Safety, Regulatory and Quality systems
• Intelligent workflows for UDI and Labeling automation

SPEAKERS  

Anusha Gangadhara
Business System Analyst
IQVIA

Michael King
Senior Director, Product & Strategy
IQVIA