Pharmacovigilance.

300+

Reports submitted

Services

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

Compliance with local requirements of other countries (including the EAEU and the CIS).

Our advantages:

Continuous security monitoring in all countries.

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

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)

Analysis of the existing pharmacovigilance system. Identify weaknesses, recommendations for improvement.

Our advantages:

We analyze the 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.

X7 Research provides training courses on Good Pharmacovigilance Practices.

Basic concepts of the pharmacovigilance.
General requirements for the implementation of the pharmacovigilance in the Russian Federation and the EAEU.
Authorized person for pharmacovigilance. Requirements for the authorized person, their appointment
Quality management of the pharmacovigilance system. Standard operating procedures.Master-File Pharmacovigilance System. Development, the main sections. The procedure for updating information.
Handling individual cases of side effects. Coding. Causes and effects of using the drug.
Clinical research safety records. Adverse reactions form. Evaluation of severity criteria.

Safety drug databases. Principles of a paperwork.
Signal management.
Development of a Periodic Update Safety Report. The main sections and principles of preparation. Information search. Terms of reporting to regulatory authorities.
Periodic safety report of a drug under development (ROOB)
Measures to minimize risks. Development of a Risk Management Plan.
Staff training.
Inspections and audits of the pharmacovigilance system. Periodic audits.