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.

Curriculum

Introduction

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

Glossary

Conclusion

Quiz