InFlow-PV

What is InFlow-PV?

All pharmacovigilance information must be recorded to ensure that all information is handled and stored to allow accurate reporting, interpretation and verification of the information.

InFlow-PV is a record management system for all documents used for pharmacovigilance activities shall ensure retrievability and traceability of decisions and measures taken to investigate safety concerns, including timelines, dates and the decision-making process.

PV activities with documented procedures:

• Responsibilities of the Qualified Person Responsible for Pharmacovigilance
• Management of Pharmacovigilance Data,
• Spontaneous Case Processing
• Reference Safety Information
• Literature review, incl search strategy
• Periodic Safety Update Reports / Aggregate reports
• Signal management / Evaluation of Safety Data
• Risk Management  / Minimization, incl. RMPs
• Clinical trials / observational studies, if applicable.

Benifits of InFlow-PV Monitoring System

• Management of pharmacovigilance data quality: Completeness of the data, Accuracy of the data and Integrity of the data.
• Timely access to all records
• Retention of documents relating to the pharmacovigilance system
• Retention of documents relating to the conduct of pharmacovigilance activities for individual vaccines Definition of applicable retention periods
• Specific measures for storage and processing of pharmacovigilance data to ensure data security and confidentiality
• Ensure strict access to documents and database to authorized personnel