Pharmacovigilance Audits and Training

Across the medicinal product lifecycle, adherence to policies, plans, procedures, laws, and regulations is critical to ensure compliance with the evolving Regulatory requirements. The appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality, should be verified through pharmacovigilance audits.

Freyr supports in pharmacovigilance training and pharmacovigilance audit-related activities, including audit plans, findings, programs, recommendations, etc.

Structure of Pharmacovigilance Audits

The risk-based approach to pharmacovigilance audits focuses on the areas of the highest risk in the organization’s pharmacovigilance system. In the context of pharmacovigilance, the risk to public health is of prime importance.

The following are different types of PV audit plans:

• Strategic-level audit planning results in an audit strategy (long-term approach), which should be endorsed by the top management.
• Tactical level audit planning, resulting in an audit program for setting audit objectives and the extent and boundaries (often termed as scope) of the PV audits and inspections in that program.
• Operational level audit planning, resulting in an audit plan for individual audit engagements, prioritizing audit tasks based on the risk, utilizing risk-based sampling, and testing approaches, reporting audit findings based on the relative risk level, and offering audit recommendations per the suggested grading system.

Process of Pharmacovigilance Audits

Freyr ensures that all your processes and products are aligned with the applicable quality, information security, compliance, and Regulatory requirements such as (but need not be limited to) the following:

Good Clinical Practice (GCP) and Good Pharmacovigilance Practice Auditor (GVP Auditor)

• ICH-harmonized Tripartite Guideline: Guideline for Good Clinical Practice - E6.
• E2B(R3) Individual Case Safety Report (ICSR) Specification and related files.
• E2C(R2) Periodic Benefit-risk Evaluation Report (PBRER).
• Other applicable ICH Guidelines.
• Guidelines on GVP Modules.
• US FDA’s Safety-reporting requirements for INDs and BA/BE studies.
• Post-marketing Safety-reporting for Human Drugs and Biological Products, Including Vaccines.
• US FDA’s Regional Implementation Specifications for ICH E2B(R3) Reporting to the Adverse Event Reporting System (FAERS).
• Providing Submissions in the Electronic Format – Post-market, non-expedited ICSRs, and Technical Questions and Answers.
• E2E Pharmacovigilance Planning.