Drug Development: Clinical Trials and Regulatory Process
Master the phases of clinical development, from initial trials to product approval, with insights from industry experts.
Course Cost
Free course
Beginner
Skill Level
6 Hours
Self-paced lessons
This course cannot be purchased separately - to access the complete learning experience, graded assignments, and earn certificates, you'll need to enroll in the full Drug Development Product Management Specialization program. You can audit this specific course for free to explore the content, which includes access to course materials and lectures. This allows you to learn at your own pace without any financial commitment.
What you'll learn
Understand the stages of clinical development
Master regulatory requirements for drug approval
Learn clinical trial design and methodology
Understand IND and NDA application processes
Gain knowledge of product labeling requirements
Develop expertise in clinical study protocols
Skills you'll gain
This course includes:
4.7 Hours PreRecorded video
6 assignments
Access on Mobile, Tablet, Desktop
FullTime access
Shareable certificate
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Top companies provide this course to enhance their employees' skills, ensuring they excel in handling complex projects and drive organizational success.





There are 7 modules in this course
This comprehensive course from UC San Diego's Skaggs School of Pharmacy covers the entire drug development process, focusing on clinical trials and regulatory requirements. Students learn about different phases of clinical development, from Phase 1 safety studies through Phase 3 efficacy trials, and the regulatory process including IND and NDA applications. The course combines theoretical knowledge with practical insights from industry experts, providing detailed understanding of clinical trial design, regulatory considerations, and product labeling requirements.
Welcome
Module 1 · 3 Minutes to complete
Regulatory Considerations When Filing an Investigational New Drug Application
Module 2 · 1 Hours to complete
Clinical Study & Start-up Activities
Module 3 · 1 Hours to complete
Clinical Trials: Phase 1
Module 4 · 1 Hours to complete
Clinical Trials: Phase 2
Module 5 · 1 Hours to complete
Industry Considerations with Phase III Clinical Trials
Module 6 · 1 Hours to complete
New Drug Application, Filing, Product Labeling
Module 7 · 1 Hours to complete
Fee Structure
Reviews
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Faculties
These are the expert instructors who will be teaching you throughout the course. With a wealth of knowledge and real-world experience, they're here to guide, inspire, and support you every step of the way. Get to know the people who will help you reach your learning goals and make the most of your journey.
Frequently asked Questions
Below are some of the most commonly asked questions about this course. We aim to provide clear and concise answers to help you better understand the course content, structure, and any other relevant information. If you have any additional questions or if your question is not listed here, please don't hesitate to reach out to our support team for further assistance.






