Pharmacovigilance

Pharmacovigilance is the set of scientific studies and activities aimed at detecting, assessing, understanding and preventing possible adverse consequences of drug use.

Granconsult provides a full range of pharmacovigilance services — from preparing a single notification to operating a full-scope pharmacovigilance function, including:

• Development of standard operating procedures for pharmaceutical manufacturers and representative offices of pharmaceutical companies
• Development and implementation of safety measures
• Development of pharmacovigilance documentation
• Continuous monitoring of the safety of drugs on the market
• Communication with regulatory authorities
• Communication with patients and other sources of adverse-event information
• Monitoring and analysis of adverse events during clinical studies
• Training and workshops on pharmacovigilance
• Preparation of periodic notifications on cases of adverse events and reactions
• Preparation of periodic drug-safety reports
• Cooperation with quality departments
• Document archiving

Russian Federal Law “On the Circulation of Medicines”:

“Entities involved in the circulation of medicines are obliged to report, in the prescribed manner, any case of adverse effect not listed in the drug’s instructions for use, any serious adverse reaction, unexpected adverse reaction or specifics of drug-drug interaction.”

The cost of pharmacovigilance work depends on the scope of services provided and is determined individually.