- The Company QMS
- Inspection gradings, including finding upgrades when cumulative
- CAPAs and approvals
- Risk analysis of findings
Pharmacovigilance Inspections
Regulatory inspections are the end result of the Company QMS assessment. Companies and Sponsors of trials need to have performed audits on all regulatory aspects to ensure compliance before the Regulatory Authorities assess with an inspection.
This course will cover how the Regulatory Agencies interact with Companies, what they will look for and expect, the grades of findings, and what happens next after the inspection and report.
The course will also cover how to prepare for the inspection.
Webinar
Jan 01 2026, Thursday
01:00 PM EDT
60
Minutes
Intermediate Level
Code: GRC0000298
- PV Compliance
- Head of Regulatory
- EU QP PVs
- Director/Manager of Pharmacovigilance
- PVQA
The reason for attending this talk is to understand where the Regulators will focus their attention when it comes to inspections involving pharmacovigilance activities from individual report production and reporting to signal detection; benefit-risk and risk minimization programs.
The focus will be on what processes are in place, training for individuals, database systems, etc… and this will involve Clinical; Regulatory; PV; IT; and QA Departments.
Serious Regulatory findings can cause clinical trials to be stopped/delayed; product suspensions; large Company fines and further Regulatory scrutiny.
Pharmacovigilance inspections are becoming increasingly more of a global occurrence. The sharing of such inspection reports between the various Regulators is again increasing, allowing Regulators to know if Sponsors of Clinical trials or license holders are in a compliant position regarding the safety of their products, which means that multiple inspections and findings can face those Companies that do not have robust internal audit programs and experienced auditors to keep them compliant.
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