RHSC PRIORITY WORK AREAS (PWAs) 

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. Each roadmap consists of 4 phases:

Phase 1: Gap Analysis

  • Establishing the current regulatory environment and identifying key challenges for regulatory convergence
  • Can be accomplished through diagnostic workshops, surveys and expert opinion  
  • Defining and prioritizing challenges with recommendations on how to best address the challenges

 

Phase 2: Implementation

  • Training as the primary means of building human and institutional capacity in executing regulatory functions
  • Promoting common science and risk-based approaches based on international technical standards and best practices
  • Training efforts to promote a new skill, ability or behaviour

 

Phase 3:Assessment of training

  • Executing other implementation aids as appropriate to address the challenges faced in that PWA

 

Phase 4: Evaluation

  • Measurement of learning and competency development 
  • Demonstration of the effectiveness of training in areas of focus in relation to actual regulatory practice
  • Adjusting and updating training activities and approaches based on evaluation findings