Pharmacovigilance

UAB AVECO provides a wide range of services related to pharmacovigilance of medicinal preparations, present on the market, for marketing authorisation holders and can take over a part of or all responsibilities of the marketing authorisation holder related to medicine safety monitoring and evaluation, or become a local safety representative.

Services:

• qualified person responsible for pharmacovigilance;
• preparation, processing, checking and consultation regarding pharmacovigilance systems, procedures, work schemes and agreements with third parties;
• registration of the marketing authorisation holder in the EudraVigilance network;
• collection of information about adverse reactions to medicines (ADRs), its processing, evaluation, electronic reporting to national authorities and the European Medicines Agency (EMEA);
• preparation and submission of periodic safety update reports to responsible authorities;
• monitoring of local scientific and medical literature and global databases;
• training of employees of the marketing authorisation holder;
• communication with competent authorities (information presentation, representation during pharmacovigilance system inspections);
• permanent monitoring of safety profile of medicinal products on the market, evaluation of the risk-benefit ratio;
• preparation of risk management plans.