150031, Yaroslavl, Uglichskaya str., 68, 1
+7 (4852) 59-38-86
info@cphd.ru
Organization of pharmacovigilance within the Russian Federation territory is an obligation of the drug manufacturer. It assumes quite complex and thorough work on formation of the team, building the pharmacovigilance system on the whole and maintaining its high-quality implementation. To control safety of the use of their drugs, manufacturers and MA holders are able to outsource, in part of fully, the activity of pharmacovigilance and submission of the information set forth by the legislation to regulatory authorities. Such initiative is an excellent solution in case the company has no staff responsible for the pharmacovigilance system and is not eager to allocate additional resources for such activities.
We have qualified personnel trained for implementation of our own pharmacovigilance system meeting all regulatory requirements effective within the RF and EAEU territory.
For data registration, we use the dedicated software developed by our company for pharmacovigilance purposes, that complies with E2B standards as well as EAEU and RF requirements.
To carry out the activity, we have elaborated all the necessary documentation structuring the work of the pharmacovigilance team within CPhD, Ltd.: our activity is regimented and controlled by the Federal Service for Surveillance in Healthcare for Yaroslavl region.
We organize and carry out clinical trials of medicinal drugs of later phases II-IV. Managing of such projects has certain peculiarities upon performing medical monitoring and requires closer attention of the project team to the control of investigational drugs safety as trials are conducted with patients.
The adverse events registered during drug clinical trials require additional expert evaluation, analysis of the event-drug relation, consideration of the registered adverse event in terms of its anticipation with processing of all the data available about safety of the investigational drug, including referenced documents.
To trace the occurrence of post-marketing adverse events with medicinal drugs, on 10 May, 2018, CPhD, Ltd. entered into a contract with Federal Service for Surveillance in Healthcare for Yaroslavl region to ensure informational cooperation and collaboration in the field of medicinal drugs safety monitoring. Under this contract, we have fine-tuned the work on collection and processing of spontaneous reports received from healthcare institutions of Yaroslavl region. This allows us to get safety messages directly and include them into periodic safety reports for your product.
The owned software and availability of qualified staff allow us to successfully render services to our customers on implementation of the pharmacovigilance system starting from phase II-IV studies and further post-marketing activities: maintenance of the pharmacovigilance master file, elaboration of regularly updated safety reports, auditing of the pharmacovigilance system, activities on alert identification, timely notifications to the customer and regulatory authorities.
During the post-marketing period, what is most important is to monitor the drug safety profile. Our team has highly competent professionals who process various sources of information, including the data from the Internet, for identification of drug-specific adverse events of all kinds. All the materials collected are submitted to the pharmacovigilance team and, after the medical evaluation and event-drug relation decision-making, we draw up a conclusion about the necessity to list this event in the periodic safety report and about its significance in the risk-benefit ratio evaluation for a certain drug.
We can implement pre-marketing and post-marketing pharmacovigilance relying completely on the data array, which guarantees a volume of comprehensive information about your drug safety.
