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Course / Course Details

Biologics/Bioisimilars Submission as per US and EU

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 0 students
  • 3 Hours
  • (0)

Course Requirements

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

Course Description

  • Introduction in Biologics
  • History of Biologics
  • Advancing Biomedical Sciencev
  • Comparison of development and characteristics between generics and biosimilars
  • Biological License Application
  • General Requirement of 351(k) pathway
  • Biologics Price Competition and Innovation Act
  • EU legal and Regulatory pathway
  • Data Requirement for Biosimilar Product in US and EU
  • Submission and Approval Process for Biosimilar

Course Curriculum

  • 2 chapters
  • 16 lectures
  • 1 quizzes
  • 3 Hours total length
Toggle all chapters
1 Biosimilar Regulation in EU
15 Min

2 Biosimilar Regulation in US
15 Min

3 PPT - Biosimilar Regulation in US
15 Min

4 PPT- Biosimilar Regulation in EU
15 Min

5 Article/Guidance - Biosimilar Information guide-EU
15 Min

6 Article/Guidance - Biosimilar Handbook-EU
15 Min

7 Article/Guidance - EMA Guidelines on Biosimilar
15 Min

8 Article/Guidance - USFDA Biosimilar Regulatory Review and Approval
15 Min

9 Article/Guidance - USFDA Biosimilar
15 Min

10 Article/Guidance - USFDA Labeling for Biosimilar
15 Min

11 Videos-Biosimilars and Biologics
1 Min

12 Video-Strategic Considerations for Successful Biosimilars Development 1
1 Min

13 Video-Strategic Considerations for Successful Biosimilars Development 2
1 Min

14 Video-Biosimilars – an overview of the route to market in the US and Europe 1
1 Min

15 Video-Biosimilars – an overview of the route to market in the US and Europe 2
1 Min

1 MCQs [Quiz]
10 Min

Instructor

Rajashri Ojha

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  • Duration 3 Hours

  • Lectures 16 lessons

  • Enrolled 0 students

  • Category: Biotech-Biosimilars

  • 1 Quizzes

  • Language: English

  • Skill Level Short Courses

  • Certificate of Completion

  • 10 Days Access

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