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Course / Course Details

Certificate Course in CTD/eCTD

  • 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


The course will cover Introduction to RA, ICh and CTD, Organization of CTD, Introduction to eCTD, eCTD Granularity, Preparing eCTD Submission, eCTD Specification for USFDA/EU, Electronic Submissions Process, 21 CFR part 11.

Course Curriculum

  • 8 chapters
  • 73 lectures
  • 8 quizzes
  • 3 Hours total length
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1 SOP for CTD/eCTD
15 Min

2 Step by Step Procedure
15 Min

3 Important guidance and articles
15 Min

4 About Us
15 Min

5 Table Of Content
15 Min

1 Regulatory Affairs Profession, role and its importance, overview of worldwide Regulatory agencies
15 Min

2 Role of various departments in Pharma Industry:
15 Min

3 PPT
15 Min

4 Articles 1
15 Min

5 Articles 2
15 Min

6 Articles 3
15 Min

7 Video- Role and Responsibility of RA
15 Min

8 Lecture Video by Rajashri Ojha
15 Min

9 MCQs 1 [Quiz]
5 Min

1 Overview of ICH
15 Min

2 INTRODUCTION AND OVERVIEW OF CTD
15 Min

3 Guidance
15 Min

4 ICH Guidance by Arvind Kadam Lecture Video 1
15 Min

5 ICH Guidance by Arvind Kadam Lecture Video 2
15 Min

6 ICH Guidance by Arvind Kadam Lecture Video 3
15 Min

7 ICH Guidance by Arvind Kadam- Lecture PPT
15 Min

8 MCQs 2 [Quiz]
5 Min

1 Module 1. Administrative and Prescribing Information (Region specific)
15 Min

2 Module 2. Common Technical Document Summaries
15 Min

3 MODULE 3: “QUALITY” – CMC SECTION OF THE CTD
15 Min

4 MODULE 4: NONCLINICAL STUDY REPORTS
15 Min

5 MODULE 5: CLINICAL STUDY REPORTS
15 Min

6 Articles
15 Min

7 common technical document (CTD) for the registration of pharmaceuticals for human use
15 Min

8 VIDEO-CTD TRIANGLE
15 Min

9 MCQs 3 [Quiz]
5 Min

1 eCTD
15 Min

2 PPT - 1
15 Min

3 PPT - 2
15 Min

4 PPT - 3
15 Min

5 DMF Video
15 Min

6 Para IV and 180 days Exclusivity
15 Min

7 Articles - 1
15 Min

8 Articles - 2
15 Min

9 eCTD Overview Video
15 Min

10 Core Concept of eCTD video 1
15 Min

11 Core Concept of eCTD video 2
15 Min

12 Core Concept of eCTD video 3
15 Min

13 eCTD Software Lecture by Shiv Somani video 1
15 Min

14 eCTD Software Lecture by Shiv Somani video 2
15 Min

15 eCTD Software Lecture by Shiv Somani video 3
15 Min

16 Video -Overview and Organization of eCTD by Rajashri Ojha
15 Min

17 CMC in detail by Rajashri Ojha - video 1
15 Min

18 CMC in detail by Rajashri Ojha - video 2
15 Min

19 MCQs 4 [Quiz]
5 Min

1 European Union
15 Min

2 European Union intro
15 Min

3 EU Regulation PPT
15 Min

4 guidance
15 Min

5 Marketing Authorization- Video
15 Min

6 EU Variation Video 1
15 Min

7 EU Variation Video 2
15 Min

8 EU Variation Video 3
15 Min

9 Variation guidelines
15 Min

10 EU-Product Life Cycle Management PPT
15 Min

11 MCQs 5 [Quiz]
5 Min

1 INTRODUCTION
15 Min

2 ELECTRONIC SUBMISSION
15 Min

3 Electronic Submissions
15 Min

4 Articles
15 Min

5 PPT
15 Min

6 FDA 21 CFR part 11
15 Min

7 Organization of CTD video 1
15 Min

8 Organization of CTD video 2
15 Min

9 Organization of CTD video 3
15 Min

10 MCQs 6 [Quiz]
5 Min

1 MCQs [Quiz]
1 Hour 20 Min

2 Final Exam CTD/eCTD [Quiz]
1 Hour 40 Min

Instructor

Rajashri Ojha

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  • Duration 3 Hours

  • Lectures 73 lessons

  • Enrolled 1 students

  • Category: Pharmaceuticals

  • 8 Quizzes

  • Language: English

  • Skill Level Long Courses

  • Certificate of Completion

  • 90 Days Access

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