PV Inspection and Audit Readiness
To determine that the marketing authorisation holder has personnel, systems and facilities in place to meet their pharmacovigilance obligations, to identify, record and address non-compliance which may pose a risk to public health, to use the inspection results as a basis for enforcement action, where considered necessary. The aim of a pharmacovigilance audit is to use objective evidence to assess the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system. The audit must be clearly documented and can only relyon verifiable evidence, such as written records and statements.
- Types of inspections
- Inspection Conduct
- Strategic Risk Planning
Related Conference of PV Inspection and Audit Readiness
May 16-17, 2025
8th International Conference on Pharmaceutical Research
&
Innovations in Pharma Industry
Rome, Italy
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PV Inspection and Audit Readiness Conference Speakers
Recommended Sessions
- Adverse drug reactions
- Artificial Intelligence in Signal Detection
- Drug Development
- Drug Safety
- Drug Tolerance
- Good Pharmacovigilance Practices
- Impacts of PV on Covid-19
- Market Research Programs
- Patient Support Programs
- Pharmaceutical Toxicology
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- Pharmacovigilance Operations
- Pharmacovigilance risk management plans
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