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.
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پښتو, বাংলা, اردو, 3 more
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
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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
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.
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Frequently asked questions
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