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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.

Master the phases of clinical development, from initial trials to product approval, with insights from industry experts.

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.

4.7

(2,295 ratings)

89,610 already enrolled

Instructors:

English

پښتو, বাংলা, اردو, 3 more

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Drug Development: Clinical Trials and Regulatory Process

This course includes

9 Hours

Of Self-paced video lessons

Beginner Level

Completion Certificate

awarded on course completion

Free course

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

Shareable certificate

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Certificate

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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

Instructor

 Joseph D. Ma
Joseph D. Ma

4.6 rating

1,137 Reviews

1,94,287 Students

3 Courses

Associate Professor of Clinical Pharmacy

Dr. Joseph D. Ma, Pharm.D., is an Associate Professor of Clinical Pharmacy at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California, San Diego. He earned his Pharmacy Doctorate from the University of California, San Francisco, and completed a postdoctoral fellowship in clinical pharmacology at Bassett Healthcare in Cooperstown, NY. Dr. Ma has a robust background in the pharmaceutical industry, having worked at Amgen from 2004 to 2007 in the Early Development Department. His current research focuses on validating methods for evaluating drug-drug interactions, a critical area in ensuring patient safety and effective medication management.In addition to his research, Dr. Ma practices at the Doris A. Howell Service at the UCSD Moores Cancer Center, where he specializes in symptom management and pain control while addressing psychological and social issues faced by patients. His courses include Drug Commercialization, Drug Development, and Drug Discovery, which are designed to equip students with essential knowledge and skills for careers in pharmacy and pharmaceutical sciences. Through his work, Dr. Ma contributes significantly to both academic education and clinical practice in the field of pharmacy.

Drug Development: Clinical Trials and Regulatory Process

This course includes

9 Hours

Of Self-paced video lessons

Beginner Level

Completion Certificate

awarded on course completion

Free course

Testimonials

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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.