PVmonitoring.net

PVmonitoring.net is a technical service solution for pharmaceutical companies in the sphere of pharmacovigilance, namely searching for mentions of adverse reaction (AR) in specialized medical and pharmaceutical printed media

The process of monitoring has several stages: data collection (subscription), data processing (digitizing), search organization (implementation of search system in the database according to key words; medicine name, INN) and final reporting with indications of AR mentions in articles if found

Monitoring solutions can be implemented in 2 ways:
1. Previously researched countries, a list of which you can see here Periodicals list. This option is dependent on printed media subscriptions and subsequent processing and monitoring being completely provided by our company;
2. Countries “on demand” this means partial involvement. Media subscriptions are provided by the Client’s Company. Data base processing and further monitoring is conducted by our company

Yes, in addition, an ordinary report (with non-adverse reaction mentions for a certain period) there is an option to receive notifications of AR mention within 24 hours from the moment it is revealed in the form of a digitized version of a printed magazine

Monitoring is conducted in accordance with the Guideline on Good Pharmacovigilance Practices (Module VI — Management and Reporting of Adverse Reactions to Medicinal Products) of the European Medicines Agency (EMA). This practice includes weekly reporting of literary searches targeted at revealing AR mentions in scientific literature

If there is no direct indication from the client on what should be considered an AR. Our specialists with medical education (practitioners) will take this decision. In other cases we mark “AR” only according to the strict demands of a client’s SOP (Standard Operating Procedure

The process of monitoring is based on the Standard Operating Procedure (SOP) of a client company. Should there be a need to change for example the form of reporting tables, it would be implemented in accordance with the client’s requirements

We produce it in 2 ways. The first is based on a client’s demand. The second is by adding material when our specialists reveal new and useful printed media on the market. To be added to the data base, a new magazine needs to be published at least twice during the course of a year

It takes 5-7 days to digitize printed media (30-50 medical magazines and newspapers) and then 1-2 days to search for key words and the creation of the report. Then 1-2 days for key word searching and creating report

All clients’ reports are available only to the client and our administrator

We are ready for an audit based on a client’s request aimed at checking the process of data collection, processing and reporting

Our specialists work with our clients to receive proper training to learn the client’s SOP requirements for monitoring and reporting

All reports are provided in the form of table with links to pdf articles

To receive a detailed presentation and demo report please contact us at: info@pvmonitoring.net.

Yes, we conduct Internet-monitoring. This process is based on a client’s requirements and indications of sources, processing and reporting