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Global Harmonization Task Force

Global Harmonization Task Force

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Global Harmonization Task Force

Mission: Inform and educate regulatory agencies around the world to ensure harmonized adoption of in silico methods

Global harmonization of regulatory frameworks is one of the leading barriers to broader adoption of digital evidence.

The Global Harmonization Task Force (GHTF) is working globally to converge towards a common framework that could eventually harmonize the different regulations. This includes developing position papers that outline best practices based on existing frameworks. These documents are available in multiple languages to ensure the correct comprehension of these practices. GHTF members participate in conferences, workshops, etc. to socialize these practices with stakeholders in engineering, quality, and regulatory affairs professionals.

The GHTF is also engaging directly with global competent authorities to socialize and educate stakeholders regarding the benefits of digital evidence to the healthcare industry and patients.

Goals

  • Lobby for a globally harmonized approach.
  • Engage directly with regulators from IMDRF members countries to inform and align.
  • Address regulatory uncertainty through the development of a globally recognized standard and/or guidance document

Multilingual Focus Documents

Marc Horner

Marc Horner

Leader of the International Affairs WG & Chair of the Global Harmonization TF

Distinguished Engineer, Ansys

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NEWS

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