Pharmacovigilance is a system of monitoring, control and regulation of the safety and effectiveness of medicines after their entry into the market and widespread use.
One important aspect of pharmacovigilance is the monitoring of literature and websites, which is necessary to promptly identify and respond to any signals of possible problems or side effects with the use of drugs.
Monitoring of scientific and medical literature and international websites is carried out by the Responsible Person for Pharmacovigilance of Adalan LLP at least once a week, in accordance with current legislation.
Description of the procedure
The responsible person receives information about the safety of medicinal products by the following methods:
- spontaneous messages,
- reports on clinical studies,
- monitoring messages from regulatory authorities,
- monitoring of local scientific, medical literature and websites of international and competent authorities
To obtain information from patients, medical workers and other applicants, Adalan LLP has organized telephone communication. Information about the telephone number and actual postal address of the company is posted in the instructions for medical use and on the packaging of the medicinal product, as well as in other information resources of the company.
The monitoring report is regularly submitted to NCELS and the Customer.