Operates within ethical, regulatory and good practice frameworks

Descriptors

  • Aptitude to work within local, regional and international regulatory and ethical frameworks, recognising guidelines and applying patient-centred good practices.
  • Able to author, review, revise medical components for regulatory submissions both locally and regionally.
  • Able to formulate responses to regulatory and health authorities, and research ethics committees.
  • Complies with all codes of practice applicable to the biopharmaceutical industry.
  • Undertakes internal mandatory training, follows applicable Standard Operating Procedures (SOPs), and has an aptitude for continuous quality improvement in the workplace.
  • Keeps up to date with regulations and assesses the impact of regulatory change on medicines development and lifecycle management.

Evidence to inform decision

  • Ethics submission documents and approvals (Protocol, Informed Consent Form, Patient Information Sheet)
  • Attendance at a Research Ethics Committee (REC) meeting.
  • Clinical Trial Application (CTA)/ Investigational New Drug (IND) Application
  • Common Technical Document (CTD) compilation and/or other regulatory submissions
  • Label change activities, documentation/consultation
  • WPBAs
  • Core competencies
  • ES report
  • Course assessment
  • DPM

Mapping to GPCs

Domain 1 – Professional values and behaviours

Domain 2 – Professional skills:

  • Practical skills

Domain 3 – Professional knowledge:

  • Professional requirements
  • National legislative requirements

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