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Drug Development: Clinical Trials and Regulatory Process
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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.

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4.7

89,610 Enrolled

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English

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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

Clinical Research
Drug Development
Clinical Trial Design
Clinical Development
IND Application
NDA Filing
Product Labeling
Regulatory Affairs
Clinical Pharmacology
Study Design

This course includes:

4.7 Hours PreRecorded video

6 assignments

Access on Mobile, Tablet, Desktop

FullTime access

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Share your certificate with prospective employers and your professional network on LinkedIn.

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Top companies offer this course to their employees

Top companies provide this course to enhance their employees' skills, ensuring they excel in handling complex projects and drive organizational success.

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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.

Drug Development: Clinical Trials and Regulatory Process

Beginner

Skill Level

6 Hours

Self-paced lessons

Course Cost

Free course

Completion

CERTIFICATE

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.