What is pharmacovigilance and what are its key processes and timelines?

Here are the answers to your quiz questions:

1. The science and activities relating to the detection, assessment, understanding and prevention of adverse or any other drug related problems

   • The definition provided describes pharmacovigilance.
   • C. Pharmacovigilance

2. Pharmacovigilance continues throughout:

   • Pharmacovigilance encompasses the entire lifecycle of a drug, from its development in clinical trials (pre-marketing) to its use after approval (post-marketing).
   • B. Pre and post marketing surveillance

3. Process of Pharmacovigilance is:

   • The typical process involves collecting and processing individual adverse event reports (case processing), analyzing these reports to identify safety signals (signal management), developing strategies to mitigate identified risks (risk management), and then submitting relevant data and reports to regulatory authorities or international centers like UMC.
   • A. Case processing, Signal management, Risk management, Submission to UMC