Health

Master 1 Clinical Operations and Data Management - Clinical Operations sub-course

  • ECTS

    60 credits

  • Duration

    1 year

  • Training structure

    Faculty of Pharmacy

  • Language(s) of instruction

    French

Presentation

Master 1 Clinical Operations and Data Management - Clinical Operations sub-course

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  • 100% exam success rate 2021-2022

    Success rates

Organization

Knowledge control

 Master 1

  • Therapeutic approaches
  • Monitoring and logistics of clinical trials:
    -Regulatory environment, pre-clinical file, clinical file
  • Essential ICH documents for conducting tests (before, during and at the end of the test).
  • Introduction to clinical database management, CDISC standards.
  • Medical writing according to ICH

 

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Open on a sandwich basis

Contract type

Professionalization contract, Apprenticeship contract

According to the provisional timetable provided by the course. 

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Internships, tutored projects

Internship

Mandatory

Length of internship

3 to 5 months

Internship abroad

Possible

Program

  • Databases - Epidemiology and health environment

    5 credits
    • Epidemiology and health environment

    • Database

      • Database Written

      • Mini Project database

  • Strat de Dvpmt prodts de santé - Gestion de prjt et dvpmt clin

    5 credits
    • Healthcare product development strategy CC

    • Health product development strategy EC

  • Elective courses Semester 1

    5 credits
    • Your choice: 1 of 4

      • Therapeutic areas - Pharmacokinetics - PEC

        5 credits
      • Scientific and technical foundations of polymer biomaterials

        5 credits
        • Scientific and technical bases of biomaterials TP

        • Scientific and technical bases of biomaterials Written

      • Enterprise risk management as seen by drt, ec and envt

        5 credits
        • Business risk management Written/Oral

        • Business risk management Written

      • Physicochemistry of health product formulation

        5 credits
        • Physicochemistry of health product formulation EC/CC

        • Physicochemistry of health product formulation Written

  • Regulatory and financial aspects, Quality and safety TC

    5 credits
    • Pharmaceutical Law

    • Regulatory aspects Written

      • Financial analysis

      • Security

      • Quality

      • Marketing

  • Biotechnologies applied to health

    5 credits
    • Biotechnologies applied to health CC

    • Biotechnologies applied to health Written

  • Modern languages and communication

    5 credits
    • English Semester 1

    • Modern languages

      • Choice: 1 of 3

        • Spanish Semester 1

          2.5 credits
        • German Semester 1

          2.5 credits
        • Other language Semester 1

          2.5 credits
    • Documentation and communication

  • Regulatory Affairs, GCP, Pharmacovigilance

    5 credits
    • Regulatory Affairs, GCP, Pharmacovigilance Project

    • Regulatory Affairs, GCP, Pharmacovigilance Written

  • Internship

    10 credits
    • Internship Report

    • Internship Oral

    • Internship Appreciation

  • Clinical trial monitoring and logistics

    5 credits
    • Monitoring and logistics

    • Hospital internship

      • Hospital internship Oral

      • Hospital internship Assessment

      • Hospital internship Report

  • English and 2nd language

    5 credits
    • English Semester 2

      2.5 credits
    • Modern languages Choice 2

      2.5 credits
      • Choice: 1 of 3

        • Other language Semester 2

          2.5 credits
        • German Semester 2

        • Spanish Semester 2

  • Introduction to clinical database management

    5 credits
    • SAS

      • SAS Pratique

      • SAS Project

    • Data

      • Data Project

      • Data Written

Admission

Access conditions