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Course / Course Details

Biologics Regulation

  • 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
  • 11 lectures
  • 1 quizzes
  • 3 Hours total length
Toggle all chapters
1 Introduction of Biologics
15 Min

2 Articles /Guidances 1
15 Min

3 Articles /Guidances 2
15 Min

4 Articles /Guidances 3
15 Min

5 Articles /Guidances 4
15 Min

6 PPT
15 Min

7 Video-Aspect of Comparability for Biologics
1 Min

8 Guide to writing IND for Biologics Video part1
1 Min

9 Guide to writing IND for Biologics Video part2
1 Min

10 NDA and BLA Application Review Process Video
1 Min

1 MCQs [Quiz]
10 Min

Instructor

Rajashri Ojha

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155 Courses

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  • Duration 3 Hours

  • Lectures 11 lessons

  • Enrolled 0 students

  • Category: Biotech-Biosimilars

  • 1 Quizzes

  • Language: English

  • Skill Level Short Courses

  • Certificate of Completion

  • 7 Days Access

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