Based on our wide experience, we’ve created a list of Q&A’s which will help you find the answers to most of your questions. Should you still have additional questions, please feel free to contact us directly on-line.
1. What is 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
2. How does it work?
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
3. What is the process of service?
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
4. Is there a notification within 24 hours in case of finding an adverse reaction (AR) mention in press?
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
5. Does this solution meet the European standards?
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
6. Who takes the decision whether it is an AR mention in the article?
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
7.Can monitoring algorithms be changed for the better compliance with the client’s requirements and internal procedures?
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
8.How can new printed media be added into an already existing data base??
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
9. How can printed media be processed promptly and converted into a digital data base?
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
10. Are all the results of monitoring kept confidential?
All clients’ reports are available only to the client and our administrator
11. Is there the possibility for a client to see the monitoring process?
We are ready for an audit based on a client’s request aimed at checking the process of data collection, processing and reporting
12. Is there any trainings for monitoring specialists?
Our specialists work with our clients to receive proper training to learn the client’s SOP requirements for monitoring and reporting
13. What is the form of a report?
All reports are provided in the form of table with links to pdf articles
14. Can i see any report example and get more detailed information about this service?
To receive a detailed presentation and demo report please contact us at: firstname.lastname@example.org.
15. Is there any monitoring of on-line sources?
Yes, we conduct Internet-monitoring. This process is based on a client’s requirements and indications of sources, processing and reporting