title: Model competencies in regulatory therapeutic product assessment: Health Canada's good review guiding principles as a reviewing community's code of intellectual conduct.
abstract: OBJECTIVE
  This article describes some work from the Therapeutic Products Directorate of Health Canada regarding Good Review Practices (GRP).
  
  
  RESULTS
  Background information is provided on the Therapeutic Products Directorate (TPD) and its regulatory activities regarding drug and medical device assessment in both the pre- and post-market setting. The TPD Good Review Guiding Principles (GRGP) are described which include a Definition of a Good Therapeutic Product Regulatory Review, Ten Hallmarks of a Good Therapeutic Product Regulatory Review and Ten Precepts. Analysis of the guiding principles discusses possible linkages between the guiding principles and intellectual virtues.
  
  
  CONCLUSIONS
  Through this analysis an hypothesis is developed that the guiding principles outline a code of intellectual conduct for Health Canada's reviewers of evidence for efficacy, safety, manufacturing quality and benefit-risk regarding therapeutic products. Opportunities to advance therapeutic product regulatory review as a scientific discipline in its own right and to acknowledge that these reviewers constitute a specific community of practice are discussed. Integration of intellectual and ethical approaches across therapeutic product review sectors is also suggested.
authors.affiliation: Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, Ottawa, Ontario, Canada. Robyn_Lim@hc-sc.gc.ca
authors.forename: Robyn R
authors.initials: RR
authors.lastname: Lim
mesh_terms: D002170:Canada; D032781:Codes of Ethics; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards; D006801:Humans; D007880:Legislation, Drug / Q000941:ethics / Q000458:organization & administration*; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D018570:Risk Assessment / Q000331:legislation & jurisprudence