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Quick Facts
| Medium Of Instructions | Mode Of Learning | Mode Of Delivery |
|---|---|---|
| English | Self Study | Video and Text Based |
Course Overview
Prof. Joseph D. Ma and Prof. Williams S. Ettouati created the Drug Development certification course, which is presented by the University of Pennsylvania, United States, in collaboration with Coursera, and is the second part of the Drug Discovery, Drug Commercialization, and Drug Development certification series. The Drug Development online course is intended to teach the various stages of clinical development as well as the regulatory responsibilities associated with the registration of new drugs.
Drug Development online classes are designed to teach the various stages of the clinical development process, which are divided into three major phases: phase 1 deals with the functioning of a new drug in the human body, phase 2 deals with testing the efficacy, safety, and side effects of the drug, and phase 3 deals with testing drugs on larger scales involving hundreds and thousands of people. Candidates will also learn how to integrate study design methodologies into clinical protocol formulation to examine the safety, tolerance, and effectiveness in several diagnostic.
The Highlights
- Certificate of completion
- Self-paced course
- English video lectures with Multiple subtitles
- 9 hours effort
- 100% online content
- Flexible deadlines
- Case Studies
- Exercises
- Graded assignments
- Graded quizzes
Programme Offerings
- Certificate of completion
- Self-paced Course
- English video lectures with multiple subtitles
- 100% online content
- Flexible Deadlines
- Case Studies
- Exercises
- Graded Assignments
- 9 hours effort
- Graded Quizzes.
Courses and Certificate Fees
| Certificate Availability | Certificate Providing Authority |
|---|---|
| yes | Coursera |
Drug Development Fee Details
Description | Total Fee in INR |
Course Fee, 1 month | Rs. 4,117 |
Course Fee, 3 months | Rs. 8,234 |
Course Fee, 6 months | Rs. 12,352 |
What you will learn
After completing the Drug Development online certification, candidates will gain a deep understanding of the fundamental principles behind the drug development process. Candidates will study the regulatory considerations while submitting an experimental new clinical drug application. Candidates will learn about the many skills required by drug development scientists for drug development, such as clinical trial design, clinical development and testing, and many more.
The Syllabus
Video
- Welcome!
Videos
- Regulatory Considerations When Filing an Investigational New Drug Application I
- Regulatory Considerations When Filing an Investigational New Drug Application II
- Regulatory Considerations When Filing an Investigational New Drug Application III
- Regulatory Considerations When Filing an Investigational New Drug Application IV
- Regulatory Considerations When Filing an Investigational New Drug Application V
Readings
- Lecture Slides
- A new Master Degree in Science in Drug Development & Product Management at UCSD
Quiz
- Regulatory Considerations When Filing an Investigational New Drug Application Quiz
Discussion Prompts
- How do high user fees impact drug development?
- The FDA's impact on drug development?
- Share interesting findings from ClinicalTrials.gov
Videos
- Clinical Study & Start-up Activities I
- Clinical Study & Start-up Activities II
- Clinical Study & Start-up Activities III
- Clinical Study & Start-up Activities IV
- Clinical Study & Start-up Activities V
Readings
- Lecture Slides
Quiz
- Clinical Study & Start-up Activities Quiz
Discussion Prompts
- What do you think are the most important ethical concerns?
Videos
- Clinical Trials: Phase 1 Part I
- Clinical Trials: Phase 1 Part II
- Clinical Trials: Phase 1 Part III
- Clinical Trials: Phase 1 Part IV
- Clinical Trials: Phase 1 Part V
Readings
- Lecture Slides
Practice Exercise
- Clinical Trials: Phase 1 Quiz
Videos
- Clinical Trials: Phase 2 Part I
- Clinical Trials: Phase 2 Part II
- Clinical Trials: Phase 2 Part III
- Clinical Trials: Phase 2 Part IV
- Clinical Trials: Phase 2 Part IV
Readings
- Lecture Slides
Quiz
- Clinical Trials: Phase 2 Quiz
Discussion Prompts
- Other major safety Phase I situations?
Videos
- Industry Considerations with Phase III Clinical Trials I
- Industry Considerations with Phase III Clinical Trials II
- Industry Considerations with Phase III Clinical Trials III
- Industry Considerations with Phase III Clinical Trials IV
- Industry Considerations with Phase III Clinical Trials V
Readings
- Lecture Slides
Quiz
- Industry Considerations with Phase III Clinical Trials Quiz
Videos
- New Drug Application, Filing, Product Labeling I
- New Drug Application, Filing, Product Labeling II
- New Drug Application, Filing, Product Labeling III
- New Drug Application, Filing, Product Labeling IV
- New Drug Application, Filing, Product Labeling V
- New Drug Application, Filing, Product Labeling VI
Readings18
- Lecture Slides
Quiz
- New Drug Application, Filing, Product Labeling Quiz
Discussion Prompts
- Where do you get data on drugs?
- Drug Promotion: Good or Bad?