Overview

Across the product life cycle, adherence to policies, plans, procedures, laws, 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 system, should be verified through audits.

Freyr provides support in audit-related activities including audit plan, audit findings, audit programme, audit recommendations etc.

Structure of PV Audits

The risk-based approach to PV audits focuses on the areas of highest risk to the organisation’s pharmacovigilance system, including its quality system for pharmacovigilance activities. In the context of pharmacovigilance, the risk to public health is of prime importance. Risk can be assessed at the following stages:

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

Process of PV 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 (GVP)

  • ICH Harmonised 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 Good Pharmacovigilance Practices (GVP) Modules
  • FDA Safety Reporting Requirements for INDs and BA/BE Studies
  • Post Marketing Safety Reporting for Human Drug and Biological Products Including Vaccines
  • US FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the US FDA Adverse Event Reporting System (FAERS)
  • Providing Submissions in Electronic Format – Post Market Non-Expedited ICSRs Technical Questions and Answers
  • E2E Pharmacovigilance Planning

Freyr PV Training

  • Skill Gap Assessment of the Pharmacovigilance staff at the Sponsor Location
  • Training on Audits and Inspections
  • Training Programs on Safety Specific Topics
  • Regulations/Guidelines Assessment