Pillar #4: Drug Safety - Pharmacovigilance

Pillar #4: Drug Safety - Pharmacovigilance

This course is part of Drug Development and Pharmacoepidemiology Specialization

Instructor: Jung-Im Shin

11,845 already enrolled

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4 modules

Gain insight into a topic and learn the fundamentals.

5 hours to complete

Flexible schedule

Learn at your own pace

4 modules

Gain insight into a topic and learn the fundamentals.

5 hours to complete

Flexible schedule

Learn at your own pace

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

Skills you'll gain

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Assessments

4 assignments

Taught in English

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This course is part of the Drug Development and Pharmacoepidemiology Specialization

When you enroll in this course, you'll also be enrolled in this Specialization.

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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 videosTotal 33 minutes

Pharmacovigillance12 minutes
Regulatory Requirements6 minutes
Science of Safety Signal Detection6 minutes
How to Assess Causal Effects Between a Drug and an Adverse Event?4 minutes
Post-Authorization Safety Studies, Phase 45 minutes

2 readingsTotal 20 minutes

Course Resources and Technical Support10 minutes
Introduction to Drug Safety10 minutes

1 assignmentTotal 30 minutes

Module 1 Knowledge Check30 minutes

What's included

5 videos2 readings1 assignment

5 videosTotal 29 minutes

What is Passive Surveillance?3 minutes
Passive Surveillance System in the United State9 minutes
Worldwide Passive Surveillance System4 minutes
Analyses of Passively Reported Events8 minutes
Strengths and Limitations of Passive Methods5 minutes

2 readingsTotal 15 minutes

WHO Programme for International Drug Monitoring (WHO PIDM)5 minutes
Pharmacovigilance: Passive Surveillance10 minutes

1 assignmentTotal 30 minutes

Module 2 Knowledge Check30 minutes

What's included

5 videos1 reading1 assignment

What's included

3 videos2 readings1 assignment

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Instructor

Jung-Im Shin

Johns Hopkins University

1 Course11,845 learners

Offered by

Johns Hopkins University

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