Subject: Subject Sylbus: Clinical Studies and Regulation - 138009

Clinical Studies and Regulation - 138009
Will not be given the year
Credit
Points
2.0
 
  Lecture Exercise Laboratory Project or
Seminar
House
Work
Weekly
Hours
2       3

Determination of the grade subject to submitting the final thesis.


Prerequisites Int.to Probability and Statistics 094481
or Statistics for Managers 098740
or Biostatistics for Biologists 134154
or Biostatistics 274219


Demonstrating the Effectiveness and Safety of New Medical Products Is a Critical Part of the Product Development Process. Clinical Trials and Regulatory Approval for New Medical Technologies Are Key Components of Successful Product Commercialization. This Course Discusses the Basics of Planning and Performing Clinical Trials Along with the Global Regulatory Framework.
Students Are Expected to Understand the Different Types of Study Design, Study Protocol Structure and Content as Well as the Requirements for Planning, Conducting and Completing a Clinical Trial. Students Will Also Gain Basic Knowledge of the Principles and Requirements of Worldwide Regulations That Govern the Design, Fabrication, and Maintenance of Medical Products.


Created in 15/08/2022 Time 06:30:49