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Course / Course Details

Certificate Course in Pharmacovigilance [PV]

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 3 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

This course will cover Introduction and Objectives of Pharmacovigilance, Drug surveillance-WHO, Classification of ADR, The importance of reporting ADR, The effects of ADRs, Pre marketing studies, Post-marketing surveillance (PMS), Pharmacovigilance Methods, Drug Event Monitoring, Uppsala Monitoring Centre, The National Pharmacovigilance Centers, Pharmacovigilance in Drug Regulation, Clinical trial regulation, Post-marketing safety monitoring, Signal Detection & Analysis, Good Pharmacovigilance Practices, Periodic Safety Update Reports: General principles, Submission of PSURs

Course Curriculum

  • 11 chapters
  • 74 lectures
  • 10 quizzes
  • 3 Hours total length
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1 SOP for Pharmacovigilance
15 Min

2 About Us
15 Min

3 Table Of Content
15 Min

1 INTRODUCTION AND OBJECTIVE OF PHARMACOVIGILANCE
15 Min

2 Article 1
15 Min

3 Article 2
15 Min

4 PPT
15 Min

5 Pharmacovigilance Video
15 Min

6 Pharmacovigilance Mayur Kanchalwar Lecture Video-1
15 Min

7 Pharmacovigilance Mayur Kanchalwar Lecture Video-2
15 Min

8 Pharmacovigilance Mayur Kanchalwar Lecture Video-3
15 Min

9 Pharmacovigilance Mayur Kanchalwar Lecture Video-4
15 Min

10 MCQs 1 [Quiz]
5 Min

1 Content of pharmacovigilance
15 Min

2 Article 1
15 Min

3 Article 2
15 Min

4 Article 3
15 Min

5 Article 4
15 Min

6 Article 5
N/A

7 Article 6
15 Min

8 Basic Terminologies in Pharmacovigilance video 1
15 Min

9 Basic Terminologies in Pharmacovigilance video 2
15 Min

10 Basic Terminologies in Pharmacovigilance video 3
15 Min

11 MCQs 2 [Quiz]
5 Min

1 ICH Guidelines
15 Min

2 PPT
15 Min

3 S1-Carcinogenicity Studies
15 Min

4 S2 Genotoxicity Studies
15 Min

5 S3A - S3B Toxicokinetics and Pharmacokinetics
15 Min

6 S4 Toxicity Testing
15 Min

7 S5 Reproductive Toxicology
15 Min

8 S6 Biotechnological Products
15 Min

9 S7A - S7B Pharmacology Studies
15 Min

10 S8 Immunotoxicity Studies for Human Pharmaceuticals
15 Min

11 S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
15 Min

12 S10 Photosafety Evaluation of Pharmaceuticals
15 Min

13 MCQs 3 [Quiz]
5 Min

1 Passive Surveillance
15 Min

2 Active Surveillance and Comparative Observational Studies
15 Min

3 Targeted Clinical Investigations and Descriptive Studies
15 Min

4 Article 1
15 Min

5 Article 2
15 Min

6 Pharmacovigilance lecture Video
N/A

7 MCQs 4 [Quiz]
5 Min

1 Wings of Pharmacovigilance-1
15 Min

2 Wings of Pharmacovigilance-2
15 Min

3 CIOMS
15 Min

4 PPT
15 Min

5 MCQs 5 [Quiz]
5 Min

1 PHARMACOVIGILANCE IN DRUG REGULATION
15 Min

2 Project management
15 Min

3 PHARMACOVIGILANCE IN INTERNATIONAL HEALTH
15 Min

4 Pharmacovigilance Program of India video
15 Min

5 PPT
15 Min

6 MCQs 6 [Quiz]
5 Min

1 Major challenges of Pharmacovigilance
15 Min

2 PV program of India
15 Min

3 Article
15 Min

4 Pharmacovigilance video 1.1
15 Min

5 Pharmacovigilance video 1.2
15 Min

6 MCQs 7 [Quiz]
5 Min

1 SIGNAL DETECTION & ANALYSIS
15 Min

2 Clinical Safety and Pharmacovigilance
15 Min

3 Article
15 Min

4 PPT
15 Min

5 Pharmacovigilance Causality assessment Video
15 Min

6 MCQs 8 [Quiz]
5 Min

1 Good Pharmacovigilance Practices
15 Min

2 Guidance 1
15 Min

3 Guidance 2
15 Min

4 Good Pharmacovigilance practices Videos
15 Min

5 2019 Gxp Updates Pharmacovigilance
15 Min

6 MCQs 9 [Quiz]
5 Min

1 FINAL EXAM [Quiz]
1 Hour 20 Min

Instructor

Rajashri Ojha

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  • Duration 3 Hours

  • Lectures 74 lessons

  • Enrolled 3 students

  • Category: Pharmaceuticals

  • 10 Quizzes

  • Language: English

  • Skill Level Long Courses

  • Certificate of Completion

  • 90 Days Access

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