Tutorial 14: Pharmacovigilance Audits and Inspections

Every Pharmacovigilance (PV) department undergoes pharmacovigilance inspections by regulatory or health authorities as well as internal audits and audits conducted by service provider or partners. It is important to know how to handle audits and inspections and how to respond to requests and findings.
Since pharmacovigilance inspections by Regulatory Authorities have become increasingly intensive this tutorial will teach you how to comply with applicable regulations

Professionals who work in:

• Pharmacovigilance / Drug Safety
• Regulatory Affairs
• Quality Management
• Compliance
  

At the conclusion of this tutorial, attendees will be able to:

• Understand how to comply with national and international regulatory PV legislation and guidelines with respect to most relevant issues during inspection
• Create audit plans which anticipate the activities of regulatory PV inspections
• Respond to PV audit/inspection questions and/or requests in a comprehensive and structured way