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This course is part of our Post-Degree Diploma in Clinical Trials Management.

 

How do drugs and medical devices go from lab to clinical use? What research is required to get them to patients and demonstrate safety and effectiveness along the way? This course allows students to gain knowledge and understanding of the drug development process, the regulatory framework and explore the differences between drugs and medical devices.

Topics

  • Legislation on the drug approval process
  • Phases of drug and medical device development
  • The pre-clinical and clinical activities required for drug approval
  • Clinical trial outputs - safety and efficacy data and interpretation

 

Diploma Program Progression

Successful completion of first term courses (Minimum 70% average with no single final grade below 65%) is required for progression to second term courses. Successful completion of first and second term courses is required for progression to practicum. 

Applies Towards the Following Certificates

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Register - Select a section to enroll in
Schedule
View Details
Total Hours
36.0
Format
Online: Paced  
Fee
Clinical Trials Management - Course Fee (0.5 units) $0.00 Click here to get more information
Instructors
  • Santosh Deshpande

What to Expect

This is an interactive course; you will engage online with your class and instructor through our online learning management system. Plan to log into your course regularly throughout the week.

You can expect to spend approximately six hours of work per week on course requirements.

Completion Requirements

This is a graded course. Evaluation will be based on any combination of participation, exams/quizzes and assignments.

Textbook

TBA

Schedule
View Details
Total Hours
36.0
Location
Format
Hybrid  
Fee
Clinical Trials Management - Course Fee (0.5 units) $0.00 Click here to get more information
Instructors

What to Expect

This is an interactive course; you will engage face-to-face during the in-class portion and online with your class and instructor through our online learning management system. Plan to log into your course regularly throughout the week.

You can expect to spend approximately six hours of work per week on course requirements. Students are expected to attend six in person classes. A schedule will be provided.

Completion Requirements

This is a graded course. Evaluation will be based on any combination of attendance in in-person classes, participation, exams/quizzes and assignments.

Textbook

TBD

Required