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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
Lesson 3: Structure and Process on a Pass in NIS
Lesson 4: Study Protocol
Lesson 5: Reporting of Pharmacovigilance Data to Competent Authorities
Lesson 6: Publication of Study Results
Lesson 7: Supervision of Non-Interventional Post-Authorization Safety Studies Conducted Under an Obligation
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