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Course / Course Details

Biologics/Biosimilar Submission as per US and EU

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 0 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

  • Introduction in Biologics
  • History of Biologics
  • Advancing Biomedical Science
  • 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

  • 1 chapters
  • 3 lectures
  • 1 quizzes
  • 3 Hours total length
Toggle all chapters
1 test lesson
10 Min

2 Test bunny
1 Min

3 Biosimilar Test Quiz [Quiz]
10 Min

Instructor

Rajashri Ojha

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11 Students
141 Courses

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  • Duration 3 Hours

  • Lectures 3 lessons

  • Enrolled 0 students

  • Category: Medical Device

  • 1 Quizzes

  • Language: English

  • Skill Level Short Courses

  • Certificate of Completion

  • 7 Days Access

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