Provides up to date evaluations of the benefits and risks of medical products

Descriptors

  • Uses the benefit-risk evaluation of a medical product to perform a patient, product or product development impact assessment.
  • Applies statistical principles including quantitative and relevant qualitative methods to reach conclusions in benefit-risk evaluation.
  • Applies assessments of benefit-risk balance to reach milestone decisions in product development.
  • Provides clear explanation of the benefits and risks of a medical product to enable appropriate patient engagement.
  • Proposes product management strategies and risk mitigation.

Evidence to inform decision

  • First in Human (FiH) and early (exploratory) development study documentation
  • Clinical Overviews and Summaries
  • Drug safety and pharmacovigilance signal management documentation
  • Managing off-licence access to medicines
  • Patient engagement activities in product development
  • WPBAs
  • Core competencies
  • ES report
  • Course assessment
  • DPM

Mapping to GPCs

Domain 1 – Professional values and behaviour

Domain 2 – Professional skills:

  • Practical skills
  • Communication and interpersonal skills
  • Dealing with complexity and uncertainty

Domain 3 – Professional knowledge:

  • Professional requirements

Domain 4 – Capabilities in health promotion and illness prevention

Domain 5 – Capabilities in leadership and team working

Domain 6 – Capabilities in patient safety and quality improvement:

  • Patient safety
  • Quality improvement

Domain 9 – Capabilities in research and scholarship