Individual case processing in pharmacovigilance involves several steps.

Let's take a look at the workflow involved in individual case processing.

Individual case processing in pharmacovigilance involves several steps to ensure the timely detection, assessment, and reporting of adverse drug reactions (ADRs) or other safety concerns related to a medicinal product. The workflow includes:

1. Case receipt: Receive the case report from various sources, such as healthcare professionals, patients, or regulatory authorities.

2. Case triage: Prioritize cases based on seriousness, expectedness, and local regulatory requirements.

3. Data entry: Enter the case details into a pharmacovigilance database, capturing relevant information like patient demographics, drug details, adverse events, and medical history.

4. Quality check: Verify the accuracy and completeness of the entered data.

5. Coding: Assign standardized medical terminology codes to the adverse events, drugs, and medical history using coding dictionaries like MedDRA and WHO-Drug.

6. Case narrative: Write a structured, chronological summary of the case, highlighting the essential information.

7. Medical Review: Evaluate the case to determine the relationship between the drug and the reported ADR, and assess its seriousness, expectedness, and causality.

8. Expedited reporting hi: Submit serious and unexpected cases to regulatory authorities within the required timeframes, usually 15 days for ICSRS and 7 days for fatal/life-threatening cases.

9. Follow-up: Request additional information from the reporter if needed and update the case accordingly.

10. Signal detection: Monitor the accumulated data for potential safety signals or trends indicating new or changing risks associated with the drug. 

11. Risk management: Implement risk minimization measures, communicate safety information to stakeholders, and update product labeling when necessary.

12. Periodic reporting: Prepare and submit periodic safety update reports (PSURS) to regulatory authorities summarizing the safety profile of the drug.

13. Archiving: Store and maintain case records in compliance with regulatory requirements and company policies.

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