Pillar #4: Drug Safety - Pharmacovigilance
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Pillar #4: Drug Safety - Pharmacovigilance
This course is part of Drug Development and Pharmacoepidemiology Specialization
Instructor: Jung-Im Shin
11,375 already enrolled
Included with
What you'll learn
Explain the types of pharmacovigilance, including with their limitations and strengths, and key surveillance systems in the US and globally
Describe US regulatory requirements for drug safety, including phase 4 post-marketing studies
Recognize real-world impact of drug safety research and its role in shaping regulatory actions and policies
Details to know
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There are 4 modules in this course
This course provides a comprehensive overview of drug safety and pharmacovigilance. We start with the fundamentals of pharmacovigilance and regulatory requirements, including phase 4 post-marketing safety studies. We discuss passive and active surveillance methods, exploring key surveillance systems in the US and globally. The course concludes with real-world examples, demonstrating how drug safety research impacts regulatory decisions and prescribing practices.
What's included
5 videos2 readings1 assignment
5 videos•Total 33 minutes
- Pharmacovigillance•12 minutes
- Regulatory Requirements•6 minutes
- Science of Safety Signal Detection•6 minutes
- How to Assess Causal Effects Between a Drug and an Adverse Event?•4 minutes
- Post-Authorization Safety Studies, Phase 4•5 minutes
2 readings•Total 20 minutes
- Course Resources and Technical Support•10 minutes
- Introduction to Drug Safety•10 minutes
1 assignment•Total 30 minutes
- Module 1 Knowledge Check•30 minutes
What's included
5 videos2 readings1 assignment
5 videos•Total 29 minutes
- What is Passive Surveillance?•3 minutes
- Passive Surveillance System in the United State•9 minutes
- Worldwide Passive Surveillance System•4 minutes
- Analyses of Passively Reported Events•8 minutes
- Strengths and Limitations of Passive Methods•5 minutes
2 readings•Total 15 minutes
- WHO Programme for International Drug Monitoring (WHO PIDM)•5 minutes
- Pharmacovigilance: Passive Surveillance•10 minutes
1 assignment•Total 30 minutes
- Module 2 Knowledge Check•30 minutes
What's included
5 videos1 reading1 assignment
5 videos•Total 34 minutes
- Definition of Active Surveillance•6 minutes
- Use of Sentinel Sites•4 minutes
- Use of Drug Event Monitoring and Registries•3 minutes
- Use of Big Data•14 minutes
- International Active Surveillance System•7 minutes
1 reading•Total 10 minutes
- Pharmacovigilance: Active Surveillance•10 minutes
1 assignment•Total 30 minutes
- Module 3 Knowledge Check•30 minutes
What's included
3 videos2 readings1 assignment
3 videos•Total 32 minutes
- Adverse Events and Boxed Warnings•13 minutes
- Adverse Events and Prescribing Practice Change•12 minutes
- Phase 4 Clinical Trials•7 minutes
2 readings•Total 20 minutes
- Applied Examples of Drug Safety Research•10 minutes
- Closing Thoughts•10 minutes
1 assignment•Total 30 minutes
- Module 4 Knowledge Check•30 minutes
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Reviewed on Sep 11, 2025
I badly need the certificate for free. The course was good overall.
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This very beneficial and skilled course but my certificate is not generated due to 7-days free trial & I didn't have a subscription
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I really like it. I will do more courses to improve my skills.
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