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  • Regulatory Affairs, EMEA

Regulatory Affairs, EMEA

Curriculum

  • 8 Sections
  • 60 Lessons
  • 6 Weeks
Expand all sectionsCollapse all sections
  • Module 1. Regulatory Affairs - EMEA, submissions and dossier
    7
    • 0.0
      Lecture 1.
    • 0.1
      Lecture 2.
    • 0.2
      Lecture 3.
    • 0.3
      Lecture 4.
    • 0.4
      Lecture 5.
    • 0.5
      Lecture 6.
    • 0.6
      Lecture 7.
  • Module 2. Technical Writing
    8
    • 0.0
      Lecture 1.
    • 0.1
      Lecture 2.
    • 0.2
      Lecture 3.
    • 0.3
      Lecture 4.
    • 0.4
      Lecture 5.
    • 0.5
      Lecture 6.
    • 0.6
      Lecture 7.
    • 0.7
      Lecture 8.
  • Module 3. Global Medical Systems in Regulatory Affairs Part 1
    10
    • 2.0
      Lecture 1.
    • 2.1
      Lecture 2.
    • 2.2
      Lecture 3.
    • 2.3
      Lecture 4.
    • 2.4
      Lecture 5.
    • 2.5
      Lecture 6.
    • 2.6
      Lecture 7.
    • 2.7
      Lecture 8.
    • 2.8
      Lecture 9.
    • 2.9
      Lecture 10.
  • Module 4. Global Medical Technology in Regulatory Affairs Part 2
    6
    • 3.0
      Lecture 1.
    • 3.1
      Lecture 2.
    • 3.2
      Lecture 3.
    • 3.3
      Lecture 4.
    • 3.4
      Lecture 5.
    • 3.5
      Lecture 6.
  • Module 5. Clinical Trials and Evaluation
    9
    • 4.0
      Lecture 1.
    • 4.1
      Lecture 2.
    • 4.2
      Lecture 3.
    • 4.3
      Lecture 4.
    • 4.4
      Lecture 5.
    • 4.5
      Lecture 6.
    • 4.6
      Lecture 7.
    • 4.7
      Lecture 8.
    • 4.8
      Lecture 9.
  • Module 6. Risk Management and Labelling
    7
    • 5.0
      Lecture 1.
    • 5.1
      Lecture 2.
    • 5.2
      Lecture 3.
    • 5.3
      Lecture 4.
    • 5.4
      Lecture 5.
    • 5.5
      Lecture 6.
    • 5.6
      Lecture 7.
  • Module 7. CMC, Sterilisation and Biocompatability
    7
    • 6.0
      Lecture 1.
    • 6.1
      Lecture 2.
    • 6.2
      Lecture 3.
    • 6.3
      Lecture 4.
    • 6.4
      Lecture 5.
    • 6.5
      Lecture 6.
    • 6.6
      Lecture 7.
  • Module 8. EU Medical Device Regulatory Affairs
    8
    • 7.0
      Lecture 1.
    • 7.1
      Lecture 2.
    • 7.2
      Lecture 3.
    • 7.3
      Lecture 4.
    • 7.4
      Lecture 5.
    • 7.5
      Lecture 6.
    • 7.6
      Dossier evaluation
      2 Days0 Questions
    • 7.7
      Submission package drafting
      7 Days0 Questions
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