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Priority Work Areas (PWAs) are identified by RHSC as key areas to achieve regulatory convergence for pharmaceutical and medical device products. Each PWA is led by champion(s) endorsed by the RHSC to lead development in that area via roadmaps with inputs from regulatory agencies, academia and industry. All roadmaps follow the same process to promote regulatory convergence in the APEC region:

  • Assess needs and level of current implementation;
  • Develop Core Curriculum and define library of internationally recognized standards, guidances, and best practices to serve as a basis for training and consistency;
  • Conduct training programs (Pilot Programs and CoE programs), symposia and workshops based upon the Core Curriculum
  • Convene at least biannual PWA Steering Committee meetings to encourage information sharing across CoEs, updating of PWA-related materials, and to serve as a resource for those wishing to become a CoE
  • Develop measurable KPIs (Key Performance Indicators) that can demonstrate progress over time
  • Conduct periodic surveys of implementation efforts to assess progress
  • Continual training and updating of Core Curriculum and Library

For matters relating to Priority Work Areas (PWAs), please contact the respective Champions