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Course / Course Details

Dossier Preparation in CTD/eCTD

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 3 Hours
  • (0)

Course Requirements

B.Pharm/M.Pharm/PhD/BSc/MSc/
B.Tech/M.Tech/Pharma, Healthcare Working Professionals.

Course Curriculum

  • 4 chapters
  • 30 lectures
  • 1 quizzes
  • 3 Hours total length
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1 Dossier Preparation
N/A

1 DOSSIER PREPARATION IN pCTD AND eCTD FORMAT
15 Min

2 Guidance 1
15 Min

3 Guidance 2
15 Min

4 Guidance 3
15 Min

5 Guidance 4
15 Min

6 Guidance 5
15 Min

7 Guidance 6
15 Min

8 Guidance 7
15 Min

9 Guidance for Quality Module Part 3S-drug substance
15 Min

10 Guidance for Quality Module Part 3P-drug product
15 Min

11 ICH Guidance for M4-common technical document (CTD) for the registration of pharmaceuticals for human use
15 Min

12 PPT 1
15 Min

13 PPT 2
15 Min

14 PPT 3
15 Min

15 video-CTD Triangle
1 Min

16 Core Concept of eCTD video 1
1 Min

17 Core Concept of eCTD video 2
1 Min

18 Core Concept of eCTD video 3
1 Min

19 eCTD Software Lecture by Shiv Somani video 1
1 Min

20 eCTD Software Lecture by Shiv Somani video 2
1 Min

21 eCTD Software Lecture by Shiv Somani video 3
1 Min

22 Video-Overview and Organization of eCTD by Rajashri Ojha
1 Min

23 Video-CMC Writing in Detail Video 1
1 Min

24 Video-CMC Writing in Detail Video 2
1 Min

25 eCTD Lecture by Sairam Reddy video 1
1 Min

26 eCTD Lecture by Sairam Reddy video 2
1 Min

1 DOSSIER PREPARATION IN ACTD FORMAT
15 Min

2 Guidance
15 Min

1 MCQs [Quiz]
10 Min

Instructor

Rajashri Ojha

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154 Courses

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  • Duration 3 Hours

  • Lectures 30 lessons

  • Category: Pharmaceuticals

  • 1 Quizzes

  • Language: English

  • Skill Level Short Courses

  • Certificate of Completion

  • 14 Days Access

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