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Course / Course Details

RA/QA in BIOTECH-Biosimilars and Biologicals

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 0 students
  • N/A
  • (0)

Course Requirements

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

Course Curriculum

  • 11 chapters
  • 31 lectures
  • 11 quizzes
  • N/A total length
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1 Description
20 Min

2 videos on introduction of biotechnology
20 Min

3 videos on Biologics drug and Biosimilars
20 Min

4 Difference between Biotechnology and Biological products
20 Min

5 Biotech Quiz-1 [Quiz]
15 Min

1 manufacturing of biological produt descriptions
20 Min

2 Biological product manufacturing
20 Min

3 Biotech Quiz-2 [Quiz]
15 Min

1 Introduction to biosimilars
20 Min

2 Basics of biosimilars-videos
N/A

3 Biotech Quiz-3 [Quiz]
10 Min

1 Clinical development & PV of Biosimilar
20 Min

2 Biotech Quiz-4 [Quiz]
25 Min

1 LC-MS Peptide Mapping-videos 1
20 Min

2 Intact Mass & Subunit Analyses of a Therapeutic Antibody-video 2
20 Min

3 Glycan Analysis of a Biologic Therapeutic-video 3
20 Min

4 Analytical Characterization of Biologics
20 Min

5 Biotech Quiz-5 [Quiz]
25 Min

1 Biosimilar Registration Procedure of Biosimilar in US and European Union (EU)
20 Min

2 Biotech Quiz-6 [Quiz]
23 Min

1 For biosimilar or biologic drugs Regulatory Submission Requirements as per CANADA
20 Min

2 Biotech Quiz-7 [Quiz]
14 Min

1 BIotech-biosimilar RA approval ASEAN, CIS, MENA and other RoW markets
20 Min

2 Biotech Quiz-8 [Quiz]
30 Min

1 Biosimilar Regulation in the ASEAN
20 Min

2 Biotech Quiz-9 [Quiz]
30 Min

1 Biological Regulation As per India-CDSCO
20 Min

2 videos on Biosimilar -INDIA
20 Min

3 Biotech Quiz-10 [Quiz]
25 Min

1 Regulatory Requirements for Biological Products as per CTD-eCTD Format
20 Min

2 Biotech Quiz-11 [Quiz]
15 Min

Instructor

Rajashri Ojha

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  • Duration N/A

  • Lectures 31 lessons

  • Enrolled 0 students

  • Category: Biotech-Biosimilars

  • 11 Quizzes

  • Language: English

  • Skill Level Long Courses

  • Certificate of Completion

  • 90 Days Access

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