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Course / Course Details

Effective CMC Writing and Review Skill

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 0 students
  • 3 Hours
  • (0)

Course Requirements

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.


Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

This course will cover Basics of CMCs, effective technical CMC Writing skills, CTD Module 3-Quality Overall Summary,  Purpose and Content of Module 3, Difference between technical and scientific writing skills, How to organize CTD modules, Regulatory challenges of CMC requirements

Course Curriculum

  • 8 chapters
  • 26 lectures
  • 1 quizzes
  • 3 Hours total length
Toggle all chapters
1 Scientific Writing Skills
1 Min

1 Basic of CMC Video 1
1 Min

2 Basic of CMC Video 2
1 Min

3 Basic of CMC Video 3
1 Min

4 Basic of CMC Video 4
1 Min

1 CTD-eCTD Videos 1
1 Min

2 CTD-eCTD Videos 2
1 Min

3 CTD-eCTD Videos 3
1 Min

4 CTD-eCTD Videos 4
1 Min

1 CMC drug substance video 1
1 Min

2 CMC drug substance video 2
1 Min

1 CMC Module Drug Product Video 1
1 Min

2 CMC Module Drug Product Video 2
1 Min

3 CMC Module Drug Product Video 3
1 Min

4 CMC Module Drug Product Video 4
1 Min

5 CMC Module Drug Product Video 5
1 Min

1 PPT - 1
15 Min

2 PPT - 2
15 Min

1 Articles/Guidances 1
15 Min

2 Articles/Guidances 2
15 Min

3 Articles/Guidances 3
15 Min

4 Articles/Guidances 4
15 Min

5 Articles/Guidances 5
15 Min

6 Articles/Guidances 6
15 Min

7 Articles/Guidances 7
15 Min

1 Effective CMC Writing and Review Skill MCQ [Quiz]
15 Min

Instructor

Rajashri Ojha

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  • Duration 3 Hours

  • Lectures 26 lessons

  • Enrolled 0 students

  • Category: Pharmaceutical

  • 1 Quizzes

  • Language: English

  • Skill Level Short Courses

  • Certificate of Completion

  • 7 Days Access

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