Non-Interventional Studies (NIS) Module 1: General Principles

Non-Intervention Studies  (NIS) are carried out in uncontrolled settings unlike 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.

Curriculum

Lesson 1: What is NIS and Some Important Definitions?

• NIS Definitions

Lesson 2: Ethical Considerations

Lesson 3: Post-Authorization Studies in Europe

• Post-Authorization Safety Study (PASS)
• Post-Authorization Efficacy Study (PAES)
• Requirements for Disclosure of Non-Interventional Studies Reports

Lesson 4: Post-Authorization Studies in the USA

Lesson 5: Operations of the EU Network

• Procedure for Imposing Post-Authorization Safety Studies
• Request for Post-Authorization Safety Study as Part of the Initial Marketing Authorization Application
• Request for A Post-Authorization Safety Study During a Post-Authorization Regulatory Procedure
• Request for a Post-Authorization Safety Study Due to an Emerging Safety Concern
• Joint Post-Authorization Safety Studies
• Written Observations in Response to the Imposition of an Obligation
• Supervision of Non-Interventional Post-Authorization Safety Studies Conducted Under an Obligation
• Roles and Responsibilities of the Marketing Authorization Holder

Lesson 6: Roles and Responsibilities of the PRAC and the National Competent Authority

• Roles and Responsibilities of the Agency

Lesson 7: Changes to the Marketing Authorization Following Results from a Non-Interventional Post-Authorization Safety Study

Lesson 8: Good Pharmacovigilance Practice

• Objectives of Pharmacovigilance
• Pharmacovigilance in the EU: Roles of Different Factors
• Legal Basis, Scope, and Process for GVP
• Maintenance and Further Development of GVP
• Structure of GVP

Lesson 9: EU Data Protection Regulation – Impact on Clinical Trials & Pharmacovigilance

• What Data Protection Issues Should Be Considered When Conducting Clinical Studies?
• What Data Protection Issues Should Be Considered When Conducting Pharmacovigilance Activities?

Glossary

Quiz