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As it is impossible to get all the necessary information about a drug substance or medical device from the clinical trials in a relatively controlled setting, it is necessary to keep obtaining and obtaining information on responses to the drug once it makes it into the market. This is called “Pharmacovigilance” and may be referred to as an extension of clinical trials. This course teaches you about the handling of pharmacovigilance cases and reports. You will learn to evaluate reports for credibility and eliminate repetitions by updating information that is already present in the database. You will also learn how information is obtained for each peculiar case.
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: Pharmacovigilance and Pharmacovigilance Case Handling: Importance and Major Steps
Lesson 2: Data Collection – Receipt and Validation of a Case Report
Lesson 3: Data Collection in Special Situations
Lesson 4: Triage, Data Entry, and Assessment
Lesson 5: Maintaining Quality and Avoiding Errors in Case Handling
Lesson 6: Transmission to Authorities and Further Action