X7 Research offers a wide range of services at all stages of pharmacovigilance system, starting with individual consultations and ending with the complete management of the pharmacovigilance system.The pharmacovigilance is supervised by the Head of Pharmacovigilance Department at X7 Research, Olga Latysheva.
Olga graduated from the Irkutsk State Medical University, faculty of pharmacy.
- She has been working in the field of pharmacovigilance since 2014, including in such large pharmaceutical companies in St. Petersburg as CJSC Biocad and JSC Vertex.
- Already more than 3 years will perform the functions of an authorized person for Russian pharmaceutical companies. During this time, she was the representative of the companies, which is engaged with the regulatory authorities of Russia, the countries of the EAEU and the CIS.
- Since 2017 she has been working in contract research organization X7 Research.
X7 Research provides services in the following areas:
Pharmacovigilance Outsourcing
A comprehensive solution for small and medium-sized companies.
Our advantages:
- We fully assume all the responsibilities for pharmacovigilance
- We constantly monitor new requirements in each country and instantly react to all innovations
- We provide all necessary interactions with regulators
- We develop and implement an effective SOP system
- Reliable Authorized Person and Experienced Team
We offer a full range of services in accordance with the requirements of regulatory authorities, including the management of safety data, signal management, risk management, maintenance of a security database, screening of specialized literature and information resources (local and global), a pharmacovigilance system master file, Authorized person for pharmacovigilance, local contact persons for pharmacovigilance, development of necessary SOP, staff training, periodic internal audits, inspection support.
Pharmacovigilance system construction
An effective working system of pharmacovigilance in a short time.
Our advantages:
- We can integrate into the process of creating a pharmacovigilance system at any stage
- We will develop or improve the Master File of Pharmacovigilance System
- Create an effective SOP system built into the existing quality system
- We will develop templates of documents for comfortable further work
- We will train employees (including distance learning for remote employees)
Full readiness for any inspections.
Pharmacovigilance in other countries
Compliance with local requirements of other countries (including the EAEU and the CIS).
Our advantages:
- A wide network of contact persons for pharmacovigilance
- Compliance with the local requirements of each country
- Constant monitoring of local literature and normative documentation
- Effective interactions with local regulatory authorities
Continuous security monitoring in all countries.
Pharmacovigilance audit
Analysis of the existing pharmacovigilance system. Identify weaknesses, recommendations for improvement.
Our advantages:
- We analyze pharmacovigilance system at any level with recommendations for improvement
- We conduct pre-audit activities to prepare for audits from regulators
- We carry out annual internal audits — in accordance with the requirements of the legislation
Continuous quality control and improvement of the existing system.
Safety in clinical trials
Safety control at any phase of the study. Post-registration security study.
Our advantages:
- Management of adverse events from the time of receipt: data entry, clarification of all data, medical evaluation, follow-up monitoring before the resolution of the case of quality control in electronic reporting
- Quality system: management of safety data, its SOP system
- Maintaining a security database (own database or working in the customer database)
- Preparation of annual periodic reports on the safety of the developed medicinal products
- Support for ongoing risk/risk management, including PV signal evaluation, protocol review and interpretation of results
- Interaction with regulators
Complete safety control of your clinical trial.
Consulting services
Assistance on any questions in the field of pharmacovigilance.
Our advantages:
- Consultations on the introduction of the pharmacovigilance system in the enterprise
- Analysis and preparation of recommendations for improving the quality of the developed documentation (SOP, instructions, etc.)
- Assistance in the development and correction of periodic reports (including the compilation of reports in the format required by Roszdravnadzor)
- Assistance in the preparation of responses to requests from regulators
- Development of recommendations on training programs for employees of drug safety departments and medical/pharmaceutical representatives
We can help in a difficult situation and develop the most effective ways to solve emerging problems.
X7 Research is engaged in scientific activities, including pharmacovigilance. Working with both local and global sponsors, our team understands the importance of discussing the benefits of conducting research in the EAEU market. For foreign partners, X7 Research publishes research not only in Russian but also in English.
Below is a published short version of the scientific article. In order to download the full version, click on the link at the bottom of the page.
Pharmacovigilance system in Russia and Eurasian Economic Union (EAEU)
Pharmacovigilance (PV) is the type of activity aimed at detection, assessment, understanding, and prevention of adverse effects and any other drug-related problems.
Efficacy and safety of medicinal products registered in Russian Federation should be monitored in order to detect any adverse effects, individual intolerance, and other problems. Medical specialists, vets, patients, and owners of animals ought to be informed about any negative effects of medication.
Information about a marketing authorization holder’s (MAH’s) pharmacovigilance system should be included in a pharmacovigilance system master file (PSMF).The PSMF makes it possible to ensure that the pharmacovigilance system works in accordance with the requirements of the legislation of the Eurasian Economic Union (EAEU) member states; to confirm compliance of the system with the current requirements; to get information about any shortcomings of the system; to obtain information about risks or ineffectiveness of PV activities in some areas. Information about internal and external audits of the pharmacovigilance system must be also included in the PSMF. The detailed content of the PSMF is described in the third article of the Guideline on Good Pharmacovigilance Practices of the EAEU.
In accordance with the clause 2.14 of the Guideline on Good Pharmacovigilance Practices of the EAEU, the MAH should appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) who should meet special requirements for qualification. It is not necessary for the QPPV to have a medical or pharmacy degree, background in natural science is also suitable for this position. Nowadays expert organizations conduct training seminars that can certify qualification of the QPPV. According to the legislation of the Russian Federation, it is mandatory for the QPPV to reside on the territory of the Russian Federation. It is also worth noting that there must be no transnational delegates in the EAEU, as it is stated that for each PV system only one QPPV should be appointed.
The QPPV must report directly to the CEO of the MAH, i.e. be independent of the heads of other departments, including clinical and marketing departments. Moreover, within its authority, the QPPV should participate in audits of other departments and teach the basics of PV to employees.
The Guideline on Good Pharmacovigilance Practices of the EAEU (the clause 2.18) for the first time provides a legally enforceable opportunity to partially or completely delegate the MAH’s authorities, including functions of the QPPV, to another organization or a person (if such person/organization would be able to meet the same requirements as the MAH). At the same time, the MAH stays responsible for all pharmacovigilance activities. If a company has a small number of products, it is unreasonably expensive to maintain its own pharmacovigilance system, so it is advisable to delegate such activities. In that case, the PSMF should contain a detailed description of outsourcing, including audit results of an organization providing PV system on behalf of the MAH.
The most important stage in the life cycle of a medicinal product is the post-registration period. Benefit-risk balance is a dynamic index that depends on the experience of drug use. One of the main report documents regarding drug safety is a Periodic Safety Update Report (PSUR). The main goal of the PSUR is to present a full and critical analysis of a benefit-risk balance of a medicinal product in consideration of all new safety findings and cumulative influence of these findings on a safety and efficacy profile of a product. The PSUR structure is given in the article 8 of the Guideline on Good Pharmacovigilance Practices of the EAEU. Federal Service for Supervision in the Sphere of Health Care (Roszdravnadzor) approves timeliness of the PSUR for international non-proprietary names (INNs) and generic names. Over time, the EAEU’s PV legislation may develop a list of drugs’ harmonised birth dates and regulations regarding PSUR reporting period.
The required documentation package for the PSUR submission includes a transmittal letter, the PSUR, a summary (including translation into Russian), a current instruction for medical use of a drug. One PSUR should be presented for each active ingredient. The only exception is when an active ingredient is presented in different dosage forms or used for different indications (for example, in tablets to lower arterial pressure or in eye drops for glaucoma treatment).
Another important document within the framework of the PV is a risk management plan (RMP), a detailed description of the risk management system. In accordance with the Russian legislation, the RMP should be made at the post-marketing development stage with an exception for biologic drugs, for which the RMP should be filed with a license application. At the same time, the Guideline on Good Pharmacovigilance Practices of the EAEU indicates that it is necessary to file the RMP with license applications for any previously unregistered in the EAEU medicinal products, including previously unregistered combination products. The structure of the RMP is described in the clause 6.2.4 of the Guideline.
Thus, the pharmacovigilance system in Russia and in the EAEU is strictly regulated. The system involves all stakeholders in medicine circulation (manufacturers and marketing authorization holders, healthcare organizations and professionals, patients, regulatory authorities). The legislation of the Russian Federation in the field of pharmacovigilance is in keeping with the Guideline on Good Pharmacovigilance Practices of the EAEU.
Further improvement of pharmacovigilance in Russia and the EAEU will allow ensuring the healthcare system with safe medicinal products of high quality.
Link to article on Linkedin.