1. Description of the service
According to the legislation, all pharmaceutical companies are obliged to ensure timely exchange of documents between manufacturers of medicines and the control body. Pharmacovigilance is also intended to inform medical institutions about adverse reactions to medicines. Russia was involved in the WHO program for international monitoring of adverse impact in 2007.
"IMG" outsourcing services provides a full range of services in the field of pre-licensure and post-marketing pharmacovigilance on the territory of the Eurasian economic Union (EEU), namely:
- Development of standard operating procedures for pharmaceutical manufacturers, representative offices of pharmaceutical companies;
- Acting as a qualified authorized person for pharmacovigilance inspection on the territory of the EAEU, including the provision of "hotline" for the collection of safety information;
- Monitoring and analysis of undesirable events in clinical trials;
- Continuous monitoring of drug safety in the market;
- Creation of the pharmacovigilance system Master file;
- Monitoring of medical publications and online resources to detect undesirable events;
- Communication with patients and other sources of information on undesirable events;
- Preparation of safety reports, periodic safety reports for drugs on the post-licensure stage (PSUR) and for drugs in development / clinical trials (DSUR);
- Preparation of risk management plans (RMP) for the registration dossier;
- Interaction with regulatory authorities, representatives of partner companies of the Customer: reporting on undesirable phenomena to the competent / regulatory authorities, preparation of information letters and responses to requests;
- Conducting trainings and seminars on pharmacovigilance.
The cost of pharmacovigilance services depends on the volume of services provided, is determined individually.