Health

Master's 1 in Clinical Operations and Data Management - Clinical Operations Track

  • ECTS

    60 credits

  • Duration

    1 year

  • Training Structure

    School of Pharmacy

  • Language(s) of Instruction

    French

Overview

Master's 1 in Clinical Operations and Data Management - Clinical Operations Track

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  • 100% exam pass rate for the 2021–2022 academic year

    Success Rate

The Benefits of the Training Program

Organization

Knowledge Assessment

 Master's Degree, Year 1

  • Therapeutic Approaches
  • Clinical Trial Monitoring and Logistics:
    - Regulatory Environment, Preclinical Dossier, Clinical Dossier
  • Essential ICH documents for conducting clinical trials (before, during, and after the trial).
  • Introduction to Clinical Database Management and CDISC Standards.
  • Medical Writing in Accordance with ICH Guidelines

 

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Open on an alternating basis

Contract Type

Professional Training Contract, Apprenticeship Contract

According to the tentative schedule provided by the class. 

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Internships, supervised projects

Internship

Required

Duration of the internship

3 to 5 months

Internship Abroad

Possible

Program

  • Databases – Epidemiology and Environmental Health

    5 credits
    • Epidemiology and Environmental Health

    • Database

      • Written Database

      • Mini Project Database

  • Healthcare Product Development Strategy – Project Management and Clinical Development

    5 credits
    • CC Health Products Development Strategy

    • Health Product Development Strategy EC

  • Elective Courses, Semester 1

    5 credits
    • Choose 1 of 4

      • Therapeutic Areas - Pharmacokinetics - PEC

        5 credits
      • Scientific and Technical Foundations of Polymer Biomaterials

        5 credits
        • Scientific and Technical Foundations of Biomaterials: Lab Session

        • Scientific and Technical Foundations of Biomaterials: Written Text

      • Corporate Risk Management from the Perspectives of the DRT, the ECO, and the ENVT

        5 credits
        • Corporate Risk Management: Written/Oral

        • Corporate Risk Management Written

      • Physicochemistry of Health Product Formulation

        5 credits
        • Physicochemistry of Health Product Formulation EC/CC

        • Physicochemistry of Health Product Formulation: Written Exam

  • Regulatory and Financial Aspects, Quality and Safety TC

    5 credits
    • Pharmaceutical Law

    • Regulatory Issues (Written)

      • Financial Analysis

      • Security

      • Quality

      • Marketing

  • Biotechnology Applied to Healthcare

    5 credits
    • Biotechnology Applied to Healthcare CC

    • Biotechnology Applied to Health Written

  • Modern Languages and Communication

    5 credits
    • English, Semester 1

    • Modern Languages

      • Choose 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
    • Company Internship Report

    • Oral Business Internship

    • Company Internship Evaluation

  • Clinical Trial Monitoring and Logistics

    5 credits
    • Monitoring and Logistics

    • Hospital Internship

      • Oral Hospital Internship

      • Hospital Internship Evaluation

      • Hospital Internship Report

  • English and a Second Language

    5 credits
    • English, Semester 2

      2.5 credits
    • Modern Languages, Option 2

      2.5 credits
      • Choose 1 of 3

        • Other Language, Semester 2

          2.5 credits
        • German, Semester 2

        • Spanish, Semester 2

  • Introduction to Clinical Database Management

    5 credits
    • SAS

      • Practical SAS

      • SAS Project

    • Data

      • Project Data

      • Date Written

Admission

Admission Requirements