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Advanced Pharmacovigilance Audits and Inspections Virtual Live Training Course 48 October 2021 09:0013:30 OVERVIEW Using pharmacovigilance audit techniques allows a company to identify any existing
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How to fill out advanced pharmacovigilance audits and

01
Understand the regulatory requirements for advanced pharmacovigilance audits.
02
Develop a detailed audit plan outlining the scope, objectives, and methodology.
03
Collect all relevant documentation and data for the audit.
04
Conduct interviews with key personnel involved in pharmacovigilance activities.
05
Perform thorough review and analysis of pharmacovigilance processes and systems.
06
Identify any gaps or deficiencies and develop corrective actions.
07
Prepare a comprehensive audit report documenting findings and recommendations.
08
Present findings to relevant stakeholders and follow up on implementation of corrective actions.

Who needs advanced pharmacovigilance audits and?

01
Pharmaceutical companies involved in drug development and marketing.
02
Contract research organizations (CROs) conducting clinical trials.
03
Regulatory agencies overseeing drug safety and monitoring.
04
Healthcare providers and institutions involved in patient care and medication management.
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Advanced pharmacovigilance audits involve more in-depth examination of safety data and processes to ensure compliance with regulations and identify potential risks.
Pharmaceutical companies and drug manufacturers are required to file advanced pharmacovigilance audits.
Advanced pharmacovigilance audits can be filled out electronically through regulatory platforms or submitted in paper form.
The purpose of advanced pharmacovigilance audits is to evaluate the effectiveness of safety monitoring systems, identify trends in adverse events, and improve overall pharmacovigilance practices.
Advanced pharmacovigilance audits should include details on adverse events, risk management plans, signal detection activities, and any corrective actions taken.
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