Global Unique Device Identification (UDI)
Regulatory Operational Impact and Optimization

A Free FDAnews Webinar • Sponsored by Instem
Wednesday, Sept. 30, 2020 • 1:30 p.m. - 2:30 p.m. EDT

All of us in regulatory operations recognize the value UDI will bring to industry and patient safety. But with increasing regulatory requirements come additional tasks, that seem harder and harder to juggle while ensuring optimal market availability of our products.

You’ve probably underestimated the increasing responsibility and operational costs associated with meeting these global UDI requirements. The paradox of managing increasingly divergent and yet similar regional requirements of global UDI is challenging for us in the medical device industry to maintain compliance while increasing overall operational efficiencies. Although IT solutions are the key to compliance, organizations need the right regulatory strategy to ensure they can increase efficiencies and at a lower cost.

Health authorities around the world are creating device identification legislation regionally rather than globally. Several regional requirements are already in place and more will be implemented over the next few years, increasing the number and types of devices and the types of data they require for market authorization.

In this free webinar, our presenters will discuss the direct impact of UDI data requirements for multiple stakeholders and approaches considered across the industry to implement systems and processes. They will discuss the pros and cons of each — so you can make informed decisions as to what best suits your regulatory processes, product portfolio and market requirements.

Webinar Takeaways:

  • Why UDI implementation is critical for industry and patient safety
  • Implications for manufacturers of increased visibility by regulators
  • Compliance timelines of various UDI initiatives underway around the world
  • How and why UDI is essential to regulatory affairs operational processes
  • How manufacturers can leverage UDI data to be better prepared for regulatory scrutiny while ensuring maximum market availability of their products
  • The individual stakeholders and who should be the true custodians of UDI data
  • How to leverage UDI data to drive internal regulatory intelligence
  • How organizations can mitigate potential challenges in regulatory data management for UDI compliance while reducing their operational costs

Get a better handle on Global UDI compliance in an increasingly complex environment. Join us by registering today for this free webinar.


Who Will Benefit

  • Regulatory affairs professionals
  • Labelling teams
  • Quality assurance personnel
  • European importers
  • European distributors

Sign Up for FREE Below

Meet Your Presenters

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Kim Young

Director, Global Regulatory Intelligence, Instem

Kim Young, Instem’s director, global regulatory intelligence, is 20-year regulatory affairs professional. As Instem’s subject matter expert in regulatory intelligence and author of the popular blog RIMTell, she is responsible for monitoring market dynamics and ensuring key requirements are an integral part of Instem’s product strategy and development activities. Ms. Young has held key regulatory operations roles across the medical device, pharmaceutical and personal care product industries.

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Monir El Azzouzi

Chief Executive Officer, Easy Medical Device GmbH

Monir El Azzouzi, a medical device expert specializing in quality and regulatory affairs, is the chief executive officer of the consulting firm Easy Medical Device GmbH and has imparted his knowledge through videos, podcasts and online courses, as well as the website EasyMedicalDevice.com. Prior to this, he worked for nearly 15 years in quality operations and regulatory affairs for companies including Johnson & Johnson and Bausch + Lomb.