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

Intermediate level

Recommended experience

4 weeks to complete

at 10 hours a week

Flexible schedule

Learn at your own pace

4 course series

Get in-depth knowledge of a subject

Intermediate level

Recommended experience

4 weeks to complete

at 10 hours a week

Flexible schedule

Learn at your own pace

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

Skills you'll gain

Details to know

Shareable certificate

Add to your LinkedIn profile

Taught in English

See how employees at top companies are mastering in-demand skills

Learn more about Coursera for Business

logos of Petrobras, TATA, Danone, Capgemini, P&G and L'Oreal

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

Earn a career certificate

Add this credential to your LinkedIn profile, resume, or CV

Share it on social media and in your performance review

Specialization - 4 course series

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.

Applied Learning Project

Drug Development and Regulation: From Bench to Bedside

Course 15 hours

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

Drug Utilization: Trends, Determinants and Consequences

Course 26 hours

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

Comparative Effectiveness and Real-World Evidence

Course 36 hours

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

Drug Safety: Pharmacovigilance

Course 45 hours

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

Instructors

Jung-Im Shin

Johns Hopkins University

0 Courses0 learners

Offered by

Johns Hopkins University

Why people choose Coursera for their career

Felipe M.

Learner since 2018

"To be able to take courses at my own pace and rhythm has been an amazing experience. I can learn whenever it fits my schedule and mood."

Jennifer J.

Learner since 2020

"I directly applied the concepts and skills I learned from my courses to an exciting new project at work."

Larry W.

Learner since 2021

"When I need courses on topics that my university doesn't offer, Coursera is one of the best places to go."

Chaitanya A.

"Learning isn't just about being better at your job: it's so much more than that. Coursera allows me to learn without limits."

New to Public Health? Start here.

Open new doors with Coursera Plus

Unlimited access to 10,000+ world-class courses, hands-on projects, and job-ready certificate programs - all included in your subscription

Learn more

Advance your career with an online degree

Earn a degree from world-class universities - 100% online

Explore degrees

Join over 3,400 global companies that choose Coursera for Business

Upskill your employees to excel in the digital economy

Learn more

Frequently asked questions

This Specialization can be completed in four weeks at 6 hours/week

Minimum of an undergraduate degree and 2 years of experience in pharmacy, clinical pharmacology, epidemiology, medicine, health policy or regulation

It should be done in the given order:

Development and Regulation: From Bench to Bedside
Utilization: Trends, Determinants, and Consequences
Comparative Effectiveness and Real-World Evidence
Drug Safety: Pharmacovigilance

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, or you can audit it to view the course materials for free. 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.