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Course / Course Details

Basics of CMC & Difference between Scientific and Regulatory Writing

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 1 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

  • 4 chapters
  • 10 lectures
  • 0 quizzes
  • 3 Hours total length
Toggle all chapters
1 Basics of CMC video 1
1 Min

2 Basics of CMC video 2
1 Min

1 Difference Between Scientific and Regulatory Writing Video
1 Min

1 Organization of CTD Video 1
1 Min

2 Organization of CTD Video 2
1 Min

3 Organization of CTD Video 3
1 Min

1 Basics of CMC PPT
15 Min

2 Difference between Scientific Writing and Regulatory Writing PPT
15 Min

3 CTD-eCTD Overview PPT
15 Min

4 CMC Writing and Review Skills PPT
15 Min

Instructor

Rajashri Ojha

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  • Duration 3 Hours

  • Lectures 10 lessons

  • Enrolled 1 students

  • Category: Pharmaceutical

  • 0 Quizzes

  • Language: English

  • Skill Level Regular Courses

  • Certificate of Completion

  • 7 Days Access

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