Active Pharmacovigilance Studies
Collecting data in post-marketing environment, as part of risk management strategies
As a more proactive than reactive approach to Pharmacovigilance (PhV), the regulatory agencies and the World Health Organization (WHO) are recommending active PhV in LATAM countries to increase spontaneous reporting and promote active studies.
These PhV studies are based on epidemiological strategies and allow us to obtain safety information in a systemic, qualified and complete way, ensuring high data sensitivity and reliability. As part of a risk management strategy, active PhV collects and evaluates identified or potential risks, missing information, additional data on special populations or medicines consumption.
Eurotrials gathered all its expertise in LATAM to identify and comply with the legal PhV requirements in Latin America countries:
As patient safety always comes first, in an active PhV study Eurotrials will provide you with:
- Design, set-up and management of the PhV study through multidisciplinary teams;
- Risk management plans and continuous benefit/risk analysis;
- Collection of adverse events of interest and their report to applicable authorities;
- Preparation and submission of reports on PhV study as per local legislation.