The Pharmacovigilance Audit course will help you comply with the principles and guidelines set within legislative requirements. This course will help you conduct a diagnostic overview of pharmacovigilance activities to gain a rapid understanding of the company’s current position, against the best means of practice that correspond with regulations.
This course delivers an introduction to the basics of pharmacovigilance & drug safety, including in-depth explanations of audits & inspections, as well as an explanation of how to prepare for a pharmacovigilance inspection. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge of pharmacovigilance auditing.
1. The Pharmacovigilance Audit
2. Audits & Inspections Audits vs Inspections, Types of Audits & Inspections
3. Preparing for a Pharmacovigilance Inspection
4. Audit Items
Audit Items - Collection
Audit Items - Assessment
Audit Items - Reporting
Audit Items - Analysis
Additional Audit Items
5. Company Sources of Information to be Examined
6. Pharmacovigilance Checklist