Speakers

  • Jackie Elkin (Distinguished Advisor - Global Regulatory Affairs at Medtronic (USA))

    Jackie Elkin

    Distinguished Advisor - Global Regulatory Affairs at Medtronic (USA)

  • Tania Pearson (Senior Program Manager at Medtronic (USA))

    Tania Pearson

    Senior Program Manager at Medtronic (USA)

  • Dennis Black (UDI Program DirectorGlobal Regulatory Operations of Becton Dickinson (USA))

    Dennis Black

    UDI Program Director Global Regulatory Operations of Becton Dickinson (USA)

  • Mark Hoyle (Technical Director, UDICommercial Regulatory Affairs of Teleflex Medical (UK))

    Mark Hoyle

    Technical Director, UDI Commercial Regulatory Affairs of Teleflex Medical (UK)

Event Summary

With the Indian governments ruling of mandatory tagging of medical devices with a Unique Device Identifier (UDI) effective 2022, device manufacturers and importers are rushing to comply with the ruling. Even though this is a huge step towards increasing patient safety, supply chain efficiency, and provide a standard platform for device traceability and identification, however there is still a long way to go from an industry's adoption and implementation standpoint, as there are several fundamental questions that needs clarification being a pilot initiative. The APACMed Webinar Series on Unique Device Identifier (UDI) Program for MedTech Industry' would aim to sensitize and create awareness for the industry through global experts from markets that have adopted UDI to share their experiences and best practices in UDI.


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Module 1

8 October (Thursday), 0830 – 1030 (IST)

Facilitator: Jackie Elkin, MEDTRONIC and Tania Pearson, MEDTRONIC


Topics

  1. UDI Background
  2. Usage of UDI & why do we need UDI?
  3. Basics of UDI (UDI-DI, UDI-PI), Format of UDI-DI
  4. UDI-Carrier
  5. UDI vs Primary & Secondary Packaging
  6. Significance of UDI

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Module 2

14 October (Wednesday), 1630 – 1830 (IST)

Facilitator: Dennis Black, BECTON DICKINSON


Topics

  1. Overview of available implementation options.
  2. IMDRF Guidelines on UDI
  3. Difference between US & EU UDI
  4. Adoption of UDI (US/EU/IMDRF version)
  5. Sharing Best Practices from International & Regional Markets

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Module 3

21 October (Wednesday), 1600 – 1800 (IST)

Facilitator: Mark Hoyle, TELEFLEX


Topics

  1. Creation and Management of UDI Data
  2. How to Bar Code product using UDI
  3. Utilization of UDI Data for Track & Trace

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Oct 8 - 21, 2020

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