Have you ever taken over the counter or prescription drug? Are you curious about how these drugs are developed, approved and brought to the market? We begin by providing an overview of drug development and approval process and the role regulatory agencies, such as the US Food and Drug Administration, play in the approval process. We discuss phases of clinical trials – phases 1, 2, 3 and 4 – to evaluate efficacy and safety of drug products, along with case studies. We define pharmacoepidemiology – a scientific discipline to study use, safety and effectiveness of medical products and interventions – and the role it plays throughout the drug life cycle with relevant case studies. We also discuss how pharmacoepidemiology informs regulatory, policy and clinical decisions. Finally, we provide high-level overview of essential tools – study protocols, data sources, study designs and analysis – to conduct pharmacoepidemiologic studies.
Drug Development and Regulation: From Bench to Bedside
This course is part of Drug Development and Pharmacoepidemiology Specialization
Instructor: Hemalkumar Mehta
Included with 
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
Details to know
Add to your LinkedIn profile
May 2025
4 assignments
See how employees at top companies are mastering in-demand skills
Build your subject-matter expertise
- Learn new concepts from industry experts
- Gain a foundational understanding of a subject or tool
- Develop job-relevant skills with hands-on projects
- Earn a shareable career certificate
Earn a career certificate
Add this credential to your LinkedIn profile, resume, or CV
Share it on social media and in your performance review
There are 4 modules in this course
What's included
6 videos2 readings1 assignment
What's included
6 videos1 reading1 assignment
What's included
7 videos1 reading1 assignment
What's included
7 videos2 readings1 assignment
Instructor
Offered by
Explore more from Public Health
Johns Hopkins University
Johns Hopkins University
Johns Hopkins University
Why people choose Coursera for their career
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
Advance your career with an online degree
Earn a degree from world-class universities - 100% online
Join over 3,400 global companies that choose Coursera for Business
Upskill your employees to excel in the digital economy
Frequently asked questions
Access to lectures and assignments depends on your type of enrollment. If you take a course in audit mode, you will be able to see most course materials for free. To access graded assignments and to earn a Certificate, you will need to purchase the Certificate experience, during or after your audit. If you don't see the audit option:
The course may not offer an audit option. You can try a Free Trial instead, or apply for Financial Aid.
The course may offer 'Full Course, No Certificate' instead. This option lets you see all course materials, submit required assessments, and get a final grade. This also means that you will not be able to purchase a Certificate experience.
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. Your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile. If you only want to read and view the course content, you can audit the course for free.
If you subscribed, you get a 7-day free trial during which you can cancel at no penalty. After that, we don’t give refunds, but you can cancel your subscription at any time. See our full refund policy.
More questions
Financial aid available,