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


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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.





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




Dr. Faheem S. Khawaja
Dr. Faheem S. Khawaja (PharmD, MS) is an E-Learning content specialist, working as a Research Manager at Prime Foundation Pakistan, with 5 years of professional experience in healthcare and academia with a research interest in pharmaceutical nanotechnology and drug delivery systems. He is a highly capable and motivated Healthcare professional with superior analytical and problem-solving skills. Faheem possesses extensive knowledge of Pharmaceuticals and their regulatory bodies, database design, and medical informatics.


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