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  • Regulatory Medical Writing

Regulatory Medical Writing

Curriculum

  • 4 Sections
  • 21 Lessons
  • Lifetime
Expanse all sectionsCollapse all sections
  • Module 1
    7
    • 1.1
      Lecture 1. Introduction
    • 1.2
      Lecture 2. Medical regulatory documents overview: CTA and dossier
    • 1.3
      Lecture 3. Good Clinical Practice (GCP)
    • 1.4
      Lecture 4. Determination and Research
    • 1.5
      Lecture 5. Data Preparation
    • 1.6
      Lecture 6. Commonly Used Medical Abbreviations
    • 1.7
      Assessment 1
      5 Questions
  • Module 2
    11
    • 2.0
      Lecture 1. Writing: Article
    • 2.1
      Lecture 2. Writing: Research Protocol
    • 2.2
      Lecture 3. Protocol alignment in accordance with EU CTR
    • 2.3
      Practice
    • 2.4
      Lecture 5. Writing: Investigator’s Brochure
    • 2.5
      Lecture 6. IB alignment in accordance with EU CTR
    • 2.6
      Practice
    • 2.7
      Lecture 8. Writing: Informed Consent Form
    • 2.8
      Lecture 9. Writing: Risk Management Plan
    • 2.9
      Lecture 10. Statistics: General Principles
    • 2.10
      Assessment 2
      8 Questions
  • Module 3
    4
    • 3.0
      Lecture 1. Ethics Committee Review and Approval
    • 3.1
      Lecture 2. Use “Plain English”
    • 3.2
      Lecture 3. Tables
    • 3.3
      Lecture 4. Introduction, Methods, Results, Discussion
  • Module 4
    2
    • 4.0
      Final words
    • 4.1
      Final Assesment
      8 Questions
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Final words
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  • Courses
    • Clinical Trials
    • Regulatory Affairs
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    • Professional Specialisation
  • About
    • Academy and Lecturers
    • Admissions and Studying
    • Reviews
    • Why study at LAI?
    • LAI Code of Ethics
  • Membership
  • Articles
    • Psychology
    • Pharmaceutical Industry
    • Management
    • News & Updates
    • Communications
  • Contact
    • Careers
    • FAQ
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