Pharmacovigilance represents scientific research and activities aimed at identifying, evaluating, understanding and prevention of possible adverse effects of medicines.
RDG provides full range of services in the field of pharmacovigilance from preparation of a single notification to full support in the field of pharmacovigilance, which includes:
- Development of standard operating procedures for pharmaceutical manufacturers, representatives of pharmaceutical companies
- Development and implementation of safety measures
- Development of documentation on pharmacovigilance
- Continuous monitoring of the safety of drugs on the market
- Communications with regulatory authorities
- Communication with patients and other sources of information on adverse events
- Monitoring and analysis of adverse events in clinical studies
- Conduct of trainings and workshops on pharmacovigilance
- Preparation of periodic notifications on cases of adverse events and reactions
- Preparation of periodic safety update reports on of medicines
- Collaboration with the quality assurance departments
- Archiving of documentation
The cost of pharmacovigilance works depends on the scope of rendered services and is determined individually.