Non-Interventional Studies (NIS) Module 2: Practical Aspect

Non-Interventional studies are the class of research studies that do not interfere with the present line of therapy of the subject. These studies are great data sources for comparing the efficacy and safety of drug substances with others used to treat similar conditions at the post-marketing authorization stage. These studies may be conducted by sponsors willingly or as imposed upon them by regulatory agencies. This course goes deeper into the practical aspects of these studies teaching about the contents of reports and filing these reports with appropriate authorities and journals for accountability. Participants will also learn the importance of and relationship between PASS and Pharmacovigilance.

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: General Overview

Lesson 2: Post-authorization Safety Studies Non-Intervention Studies

• European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
• EU PAS Register
• EMA Role

Lesson 3: Structure and Process on a Pass in NIS

• Principles
• Study Registration

Lesson 4: Study Protocol

• Format and Content of the Study Protocol
• Substantial Amendments to the Study Protocol

Lesson 5: Reporting of Pharmacovigilance Data to Competent Authorities

• Data Relevant to The Risk-Benefit Balance of the Product
• Reporting of Adverse Reactions/ Adverse Events
• Study Reports

Lesson 6: Publication of Study Results

• Submission of Manuscripts Accepted for Publication
• Data Protection
• Quality Systems, Audits, and Inspections
• Impact on the Risk Management System

Lesson 7: Supervision of Non-Interventional Post-Authorization Safety Studies Conducted Under an Obligation

• Roles and Responsibilities of the PRAC and the National Competent Authority
• Roles and Responsibilities of the Agency

Lesson 8: Changes to the Marketing Authorization Following Results form a Non-Interventional Post-Authorization Safety Study

Lesson 9: Methods for Post-Authorization Safety Studies

Quiz