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The backbone of Non-Intervention Studies (NIS) is that they are carried out outside the controlled setting common to clinical trials. Patients are enlisted based on specific criteria which include their current treatment plan. These studies do not interfere with the current plan, hence, the researchers can identify specific events that influence therapy in the real world. This course serves as an introduction to the fundamentals of NIS. You will learn about the ethics and steps involved in obtaining data and drawing useful inferences from NIS.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: What is NIS and Some Important Definitions?
Lesson 2: Ethical Considerations
Lesson 3: Post-Authorization Studies in Europe
Lesson 4: Post-Authorization Studies in the USA
Lesson 5: Operations of the EU Network
Lesson 6: Roles and Responsibilities of the PRAC and the National Competent Authority
Lesson 7: Changes to the Marketing Authorization Following Results from a Non-Interventional Post-Authorization Safety Study
Lesson 8: Good Pharmacovigilance Practice
Lesson 9: EU Data Protection Regulation – Impact on Clinical Trials & Pharmacovigilance