1. [I]nfo
  2. [M]oduli
  3. [B]acheca
  4. [P]rogramma
  5. [O]rari
  6. [E]sami
  7. E[v]enti
  8. [F]iles

Generali:

  • Dipartimento: Scienze Matematiche, Fisiche E Naturali
  • Codice di verbalizzazione: 8067386
  • Metodi di insegnamento: Frontale
  • Metodi di valutazione: Orale
  • Prerequisiti: General concepts on clinical research and conducting clinical studies; good knowledge of English language.
  • Obiettivi: LEARNING OUTCOMES: The aim of the course is the learning of principal characteristics of a proper Quality System applied to clinical studies, so that it can guarantee the trustability of data as requested by the Good Clinical Practices. KNOWLEDGE AND UNDERSTANDING: The student is required to show full knowledge of general purposes of a Quality Management System in the Pharmaceutical sector and of Quality Assurance tools applicable to clinical trials. APPLYING KNOWLEDGE AND UNDERSTANDING: The student needs to know the difference between Quality control activities versus Quality assurance ones deeply and, regarding clinical trials, he/she should be able to apply all tools and techniques of a Quality Management System. MAKING JUDGEMENTS: The student should show critical capability and logical approach in discussing and finding solutions on Quality issues, showing a full comprehension and autonomy of judgement. COMMUNICATION SKILLS: The student should be able to use the proper terminology and to clearly communicate on Quality topics, by adopting schematic approaches, whenever applicable. LEARNING SKILLS: The student should be able to recognize common cross - functional aspects of different processes in the Quality context (e.g. risk based approach in different contexts) and be able to make correlations among different topics, by making practical examples too, whenever applicable.
  • Ricevimento: su appuntamento via mail

Didattica:

  • A.A.: 2021/2022
  • Canale: UNICO
  • Crediti: 6
  • Obbligo di Frequenza: No
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