GXP1050 Pharmacovigilance Case Handling

GXP1050 Pharmacovigilance Case Handling


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


  • What is Pharmacovigilance?
  • Why is Pharmacovigilance Necessary?
  • Good Pharmacovigilance Practice
  • Major Steps in Pharmacovigilance Case Handling


Lesson 2: Data Collection - Receipt and Validation of a Case Report


  • Sources of Reports
  • Receiving Data
  • Validation of Reports
  • Follow-up


Lesson 3: Data Collection in Special Situations


  • Pregnancy or Breastfeeding
  • Pediatric Population
  • Misuse, Abuse, or Overdose of Drug
  • Lack of Therapeutic Efficacy


Lesson 4: Triage, Data Entry, and Assessment


  • Triage
  • Duplicate Search
  • Complete Data Entry
  • Coding Assessment


Lesson 5: Maintaining Quality and Avoiding Errors in Case Handling


  • Quality Management
  • Errors in Case Handling


Lesson 6: Transmission to Authorities and Further Action


  • Submission of Safety Reports
  • Submission Time Frames
  • What Next?
  • Market Withdrawal









GXP1050 Pharmacovigilance Case Handling
Ellena J. Jefferson
Ellena is a CAPA Manager at Janssen Pharmaceuticals where she serves as a Training and Quality Advisor with ICON plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Ellena is a fixer who continuously strives for excellence as a way of life; not just as a job.

General info:


1 hour

Skill level:




Final exam:


Certificate of Completion:



An interesting introduction to pharmacovigilance case and report handling. This has helped the team’s perspective on the necessity of pharmacovigilance. The real-life examples were the icing on the cake.

Regina C


Training Director

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GXP1050 Pharmacovigilance Case Handling

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