Pharmacovigilance
Fulfilling pharmacovigilance obligations completely and accurately is a complex task that requires continuous attention and up-to-date expertise. For over two decades, Inparibus has been providing pharmacovigilance services to pharmaceutical companies and marketing authorization holders. With our experience and knowledge of regulatory requirements, we act as a reliable partner in ensuring that the safety monitoring of our clients’ products and all associated legal obligations are met efficiently – ranging from local Hungarian tasks to the operation of a complete pharmacovigilance system.
Our company covers the entire spectrum of pharmacovigilance, however, our services can be tailored to your specific operations and product portfolio. Besides full-scale system support, individual activites can also be provided separately, allowing the scope of cooperation to always match individual needs.
Our expert team is available throughout the entire process – from establishing processes that comply with national and European requirements to keeping related documentation up to date and ensuring the smooth execution of operational tasks.
Contact us to design the most optimal solution for any specific needs.
Comprehensive Pharmacovigilance Solutions
Our company’s most comprehensive offer is delivering complete pharmacovigilance solutions. In this arrangement, the marketing authorization holder delegates all pharmacovigilance-related responsibilities and legal obligations to our company under a contractual partnership (i.e. including performing the EU QPPV function, maintaining the PSMF, preparing RMPs, PSURs, conducting training, and managing the collection and reporting of adverse events to national authorities and the EMA through the EudraVigilance system).
Outsourcing pharmacovigilance to us has proven to save significant human and financial resources for our clients, leading to substantial improvements in efficiency.
Our regular pharmacovigilance services cover the following functions:
Setting up a Pharmacovigilance System (PSMF and SOPs)
The operation of a pharmacovigilance system is a requirement for every Marketing Authorization Holder (MAH). The fundamental document of this system is the Pharmacovigilance System Master File (PSMF), which contains the basic description of the pharmacovigilance system following strict formatting and content requirements.
An integral part of the pharmacovigilance system is a quality assurance system, the essential elements of which are Standard Operating Procedures (SOPs). These SOPs standardize the practical operation of the pharmacovigilance system, ensuring its reliability and traceability
Performing the EU QPPV function
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.
Risk Management Plan (RMP)
A detailed document with specified formatting and content criteria, outlining anticipated safety issues related to a specific product and the strategies for managing them.
Periodic Safety Update Reports (PSURs)
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.
Training
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.
Registering Adverse Drug Reactions
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.
Reporting adverse drug reactions through EudraVigilance to EMA
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.
Maintenance of Drug Information in the XEVMPD System: XEVMPD (A57) Module
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.
EudraVigilance L2A Download and Assessment
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:
- the client registers one of our staff with L2A read access in the EV system;
- 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.
Local Literature Monitoring
As part of this activity, we regularly review domestic medical literature, and if we find relevant information from a pharmacovigilance point of view, we forward it to our clients within 24 hours. Currently, we review about a hundred medical journals at least weekly.
Global Literature Monitoring
Marketing Authorization Holders must perform weekly searches in relevant international databases, filtering out pharmacovigilance-relevant findings from publications. This task can be time-consuming, especially for specific pharmaceutical products, where automated processing is not possible in the absence of specific electronic search terms. Genereally, this process requires the personal assistance of a specialist. Our company has a long-standing history of conducting this activity, with the help of our medical expertise and advanced instrastructure.
Local Pharmacovigilance Representation
Our company undertakes the local pharmacovigilance representation of foreign pharmaceutical companies. In most cases, this type of cooperation includes local literature monitoring, the transmission of pharmacovigilance cases occurring in Hungary to the foreign partner, monitoring the national authority’s website. In some cases and upon request we are performing other related activities as well.
Digital Media Monitoring
We provide our digital media monitoring service to our partners who manage social or other digital media platforms. This is to ensure adherence to relevant sections of current pharmacovigilance regulations. Within our service, we conduct regular screenings on specified pages with agreed frequency (even on a daily basis), for the timely detection of potential adverse drug reactions and other pharmacovigilance-related information. Every finding is forwarded to our partners within 24 hours, and upon request, we also undertake the assessment and reporting of relevant cases, fully complying with all regulatory requirements.
Veterinary Literature Monitoring
Our efficient system, established within the framework of human literature monitoring, is capable of conducting literature reviews in the same quality for companies involved in the manufacturing and/or distribution of veterinary medicinal products. We regularly review specialized journals in Hungary related to veterinary medicine and communicate relevant pharmacovigilance information found in these publications to our partners.
Contacts
Our colleague will respond to your inquiry as soon as possible.
1188 Budapest,
Damjanich u. 32
+36-30-957-0017
