Pharmacovigilance programs
Pharmacovigilance is monitoring of use of medicinal products in everyday clinical practice to identify previously unidentified adverse reactions or a change in the nature of adverse reactions.
Under Russian healthcare laws, the information about adverse events (drug safety reports) should be reported on a regular basis by pharmaceutical companies or their authorized representatives to the Federal Service for Surveillance in Healthcare.
In addition, when submitting a registration dossier, an applicant is supposed to present a Risk Management Plan, which is a detailed outline of pharmacovigilance measures to identify, assess, prevent or minimize the risks associated with the drug use. Particular attention is given to unwanted immunogenicity associated with the use of biological (immunobiological) products. These types of drugs require long-term monitoring as part of pharmacovigilance programs.
Clinical patient registries
Epidemiological studies
Laboratory diagnosis
Clinical trials
