According to current regulations, every Marketing Authorization Holder (MAH) is obligated to appoint a qualified individual (QPPV) who is responsible for the proper establishment and operation of the pharmacovigilance system, and is available 24/7. At Inparibus, our QPPV is a medically qualified professional who is one of the most experienced regional specialists in this field.

A detailed document with specified formatting and content criteria, outlining anticipated safety issues related to a specific product and the strategies for managing them.

In accordance with regulatory requirements, Marketing Authorization Holders (MAHs) must periodically summarize safety experiences related to a specific product or active substance in a document called Periodic Safety Update Report (PSUR). PSUR submission deadlines, as well as the precise formatting and content specifications, are outlined in the relevant documents.

It is necessary to continuously educate and train the stakeholders within the pharmacovigilance system for smooth functioning. The significance of this task becomes particularly evident during periods of substantial changes in regulatory expectations. Through regular training sessions tailored to the roles and needs of individual employees, both our partners and Inparibus ensure that every staff member involved in drug safety receives adequate training. Employees with roles not directly related to pharmacovigilance activities acquaint themselves with basic reporting methods through introductory training. This enables them to promptly forward any relevant information to the appropriate specialist.

The pharmacovigilance system is fundamentally built on the registration and processing of adverse drug reactions (and other adverse events related to drug treatment). In this capacity, we are available 24/7 to receive pharmacovigilance events and promptly forward and process them within the timeframe agreed upon with our partners.

The EudraVigilance database is the central element of the European Union pharmacovigilance system, operated under the supervision of the European Medicines Agency (EMA). In this database, every EU member state submits recorded adverse drug reactions and adverse events. We continuously perform this activity on behalf of our partners.

The EudraVigilance system’s drug information module (XEVMPD: Extended EudraVigilance Medicinal Product Dictionary) ensures the maintenance of drug information.

Authorities are increasingly focusing on the drug information module (XEVMPD) within the EudraVigilance database to be up-to-date in line with changes in European regulations. For our partners, we undertake the task of maintaining the accuracy of the data in the EV drug information module by staying in touch with the client’s regulatory affairs personnel.

Marketing Authorization Holders (MAHs) are required to regularly monitor adverse drug reactions uploaded into the EudraVigilance (EV) system, process and assess cases related to their products. Our company has substantial expertise in this area, as we’re delivering these services to numerous partners.

The cases to be processed can be submitted to us in two ways:

1. the client registers one of our staff with L2A read access in the EV system;
2. the client periodically (at least once a week) downloads the EV identifiers of newly registered cases within the given interval and provides us with this list.

Through either of the above methods, we obtain the relevant EV identifiers. We download all the corresponding cases registered in the period in XML, RTF, and PDF formats (or HTML if requested) from the EV. Additionally, we process each case with the necessary detail, (but at least including the following data: Safety Report ID, Suspect drug, Report type, Reference, Sender, and Inclusion/Exclusion criteria) and deliver the results to the client along with the downloaded files.

The functionality of our system is demonstrated by its ability to download and process several hundred cases on a weekly basis.