APAC Task Force
Mission: Nurture a community of collaboration among Regulators, Industry, and Academia in the APAC region to advance in silico methods, best practices, and policies for Regulatory Science and Innovation
The Asia-Pacific (APAC) region stands as a pivotal arena for fostering innovation, growth, and collaboration. Driven by the mission to cultivate a collaborative community among Regulators, Industry, and Academia within APAC region, the APAC Task Force emerges as a catalyst for advancement in in silico methods, best practices, and regulatory policies.
With a focus on bringing together stakeholders from governments, healthcare providers, academia, industry leaders, etc. the task force main goals harnesses to establish contacts with Regulators in the region and actively collaborating with ASME to provide standards to Regulators and translate Avicenna’s documents and white papers to disseminate Good Simulation Practices to the APAC region.
With the ultimate goal of achieving full harmonization through widespread recognition of in silico methods by global regulatory authorities, the APAC Task Force works towards producing an in silico map of IMDRF members. Furthermore, plans are underway to host a workshop in Australia, facilitating dialogue between the TGA, companies, and universities.
Goals
- Work with Avicenna membership to establish contacts with Regulators in the region
- Australia
- China *
- Japan*
- Singapore *
- South Korea
- Understand voice of “Regulatory” customer as it relates to modeling & simulation and in silico medicine
- Landscape for recognized standards (including regional and local)
- Infrastructure as it relates to reviewing submissions
- Identify need for collaboration or support from local CM&S experts including those beyond medical domain
- ASME collaboration
- Provide standards to Regulators at no charge
- Determine whether there is a need/market for translation of standards
- In parallel, continue efforts for translation of Avicenna white papers
- Identify co-leaders from the APAC region
- Leverage the Voice of the Regulators and other stakeholders in the APAC region to formulate strategic objectives
- Replace the current ASME related goal with “Support and facilitate the translation and dissemination of standards and Good Simulation Practices to the APAC region”
