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Clinical trials can only show results of applying medication or therapeutic devices to members of a controlled population usually in controlled settings. However, once the product is approved for commercialization, variation of some sort is bound to exist in how different people accommodate it. Hence, pharmacovigilance is a necessary extension of the drug discovery process where the use of a novel drug or device is monitored in the real world. This course introduces students to the various reports used in compiling data for active and passive pharmacovigilance and points out the relevance of agencies like the FDA and MHRA in collating such information.
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: Screening Scientific Literature for Pharmacovigilance Purposes
Lesson 2: Summary Reports
Lesson 3: Active Surveillance (Pharmacovigilance)
Lesson 4: Effectiveness of Risk Minimization Activities
Lesson 5: Difference in Regulation
Lesson 6: Software Solutions for Literature Management