Will I earn university credit for completing the Specialization?

There will be no degree credit awarded with this course

Is this course really 100% online? Do I need to attend any classes in person?

This course is completely online, so there’s no need to show up to a classroom in person. You can access your lectures, readings and assignments anytime and anywhere via the web or your mobile device.

Can I just enroll in a single course?

Yes! To get started, click the course card that interests you and enroll. You can enroll and complete the course to earn a shareable certificate. When you subscribe to a course that is part of a Specialization, you’re automatically subscribed to the full Specialization. Visit your learner dashboard to track your progress.

Is financial aid available?

Yes. In select learning programs, you can apply for financial aid or a scholarship if you can’t afford the enrollment fee. If fin aid or scholarship is available for your learning program selection, you’ll find a link to apply on the description page.

Can I take the course for free?

No, you cannot take this course for free. When you enroll in the course, you get access to all of the courses in the Specialization, and you earn a certificate when you complete the work. If you cannot afford the fee, you can apply for financial aid.

Drug Development and Pharmacoepidemiology Specialization

Drug Development and Pharmacoepidemiology Specialization

Use, Safety & Effectiveness of Prescription Drugs. Apply best pharmacoepidemiologic methods to prescription drugs across their lifecycle

Instructors: Jung-Im Shin

Included with Coursera Plus

Learn more

4 course series

Get in-depth knowledge of a subject

4.7

(61 reviews)

Intermediate level

Recommended experience

1 month at 10 hours a week

Flexible schedule

Earn a career credential

Share your expertise with employers

4 course series

Get in-depth knowledge of a subject

4.7

(61 reviews)

Intermediate level

Recommended experience

1 month at 10 hours a week

Flexible schedule

Earn a career credential

Share your expertise with employers

What you'll learn

Articulate core principles and analytic approaches used to quantify the use, safety and effectiveness of prescription drugs after market approval
Contribute to and critically evaluate study designs and methodologies examining product use, safety and effectiveness
Understand the complexity of optimizing the value of pharmacotherapies in clinical practice and the incentives and roles of various stakeholders

Overview

Pharmacoepidemiology is a scientific discipline that uses epidemiological methods to evaluate the use, benefits and risks of drugs, devices and biologicals. It focuses on observational research methods that use data which are generated in the usual care of patients. This four-course specialization teaches:

The drug development process
Methods for assessing use of products with real-world data
Observational methods for effectiveness evaluation
Methods for pharmacovigilance and safety evaluation

The course directors provide insights from the field to inform trainees and professionals seeking to improve the quality and safety of medication use. This course is ideally suited for early and mid-career medicine, pharmacy, and public health professionals who wish to expand their knowledge of pharmacoepidemiology and drug safety to inform their work in academic, regulatory, or industry settings.

What’s included

Shareable certificate

Add to your LinkedIn profile

Taught in English

Advance your subject-matter expertise

Learn in-demand skills from university and industry experts
Master a subject or tool with hands-on projects
Develop a deep understanding of key concepts
Earn a career certificate from Johns Hopkins University

Specialization - 4 course series

Drug Development and Regulation: From Bench to Bedside

Course 15 hours4.8 (19 ratings)View course

What you'll learn

Describe the drug development approval process and regulatory agencies’ role in approval process
Examine the role of pharmacoepidemiology throughout the drug development process and informing regulatory, clinical and policy decisions
Identify essential tools and resources to conduct pharmacoepidemiologic studies

Skills you'll gain

Clinical Trials, Drug Development, Epidemiology, Clinical Research, Data Collection, Pharmaceuticals, Statistical Analysis, Statistical Methods, Health Care Procedure and Regulation, Medical Science and Research, and Pharmacology

Drug Utilization: Trends, Determinants and Consequences

Course 26 hoursView course

What you'll learn

To explore how drug utilization research provides critical information regarding patterns, quality and determinants of prescription drug utilization
To assess methods for improving drug utilization, including value-based insurance, audit and feedback, patient education, and medication management.
To reinforce key concepts relevant to drug utilization through case studies including antibiotics, opioids, anticoagulants and generic drugs

Skills you'll gain

Health Policy, Pharmacotherapy, Epidemiology, Pharmacy, Trend Analysis, Medical Prescription, Patient Education And Counseling, Research Design, Pharmacology, Clinical Research, and Descriptive Statistics

Comparative Effectiveness and Real-World Evidence

Course 36 hours4.5 (10 ratings)View course

What you'll learn

Differentiate efficacy and effectiveness research and identify stakeholders who value this research in public health and regulatory decision-making.
Recognize the strengths and limitations of epidemiology study designs, including cohort, case-control, case-cohort, and self-controlled designs.
Use best methods of study design and analysis to control for confounding and biases in observational research

Skills you'll gain

Clinical Research, Epidemiology, Clinical Trials, Statistical Methods, Research Design, Patient Safety, Science and Research, Data Collection, Pharmaceuticals, and Research Methodologies

Drug Safety: Pharmacovigilance

Course 45 hours4.9 (48 ratings)View course

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

Patient Safety, Continuous Monitoring, Pharmacology, Drug Development, Clinical Pharmacy, Contraindication, Epidemiology, Pharmaceuticals, Drug Interaction, and Clinical Research