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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

10,259 already enrolled

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4 modules

Gain insight into a topic and learn the fundamentals.

97 reviews

5 hours to complete

Flexible schedule

Learn at your own pace

4 modules

Gain insight into a topic and learn the fundamentals.

97 reviews

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

Details to know

Shareable certificate

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Assessments

4 assignments

Taught in English

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Build your subject-matter expertise

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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Gain a foundational understanding of a subject or tool
Develop job-relevant skills with hands-on projects
Earn a shareable career certificate

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.