Event Details

Regulatory personnel in Asia Pacific tend to keep a close tab on the U.S. Food & Drug Administration's Precertification (Pre-Cert) Program in America, as they explore novel means and methods to regulate Digital Health (including software as Medical Device) in their own countries. While the Pre-Cert Program is not the only model for other countries to emulate in their individual markets, it certainly opens up discussions about other mechanisms like Pre-Approved Change Protocols, Recognition & Reliance etc.


APACMed has invited Lesley Maloney, Head of US Regulatory Policy and Global Policy Lead for Digital Health at Roche Diagnostics, and Krista Woodley, Sr. Director of Technology Quality for Digital Health and QMS at Johnson & Johnson, to provide an overview of the US FDA Precertification Program and share how can it be implemented in this region.


Moderated by Manan Hathi, Senior Manager of Regulatory Affairs Software at Stryker, the webinar will broach the following topics:

  1. What is the US FDA Precertification Program and how does it work?
  2. How are MedTech companies implementing the program for their digital health solutions? What are the benefits, challenges and key learnings?
  3. What can APAC MedTech ecosystem learn and leverage from the Pre-Cert Program?


What Can APAC Learn From US FDA Precertification Program?

Date: Tuesday, 19 May 2020

Time: 9am to 10.15am (Singapore time)


Please note that this webinar is exclusive to APACMed members only. Login details will be shared via email with those who have registered for the event, closer to the event date.

May 19, 2020

9 AM - 10:15 AM

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Speakers

  • Lesley Maloney (Head of US Regulatory Policy and Global Policy Lead, Digital Healthnd at Roche Diagnostics)

    Lesley Maloney

    Head of US Regulatory Policy and Global Policy Lead, Digital Healthnd at Roche Diagnostics

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  • Krista Woodley (Sr. Director, Technology Quality – Digital Health and QMS of Johnson & Johnson)

    Krista Woodley

    Sr. Director, Technology Quality – Digital Health and QMS of Johnson & Johnson

    Read Bio
  • Manan Hathi (Senior Manager of Regulatory Affairs Software at Stryker)

    Manan Hathi

    Senior Manager of Regulatory Affairs Software at Stryker

    Read Bio
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