European authorities discussed Pharmacovigilance

European authorities discussed Pharmacovigilance
April 26, 2021

INFARMED hosted this friday the 12th meeting under the scope of the Portuguese Presidency of the Council of the European Union. The event gathered over 100 participants of the Pharmacovigilance Risk Assessment Committee (PRAC).

During meeting the debate focused on the development of new technologies applicable to Pharmacovigilance, namely Big Data and Data Engineering. On this topic, the participants were able to learn from a case-study from Portugal.

The participants also discussed the progress being made on the COVID-19 Vaccines Safety Monitoring. EMA and some member-states presented the procedures being applied, and it was debated new ways to improve efficiency on that topic. There was also time to debate how to improve the legislation regarding the Pharmaceutical Strategy for Europe.

PRAC is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicines. The PRAC was formally established in line with the pharmacovigilance legislation which came into effect in 2012 to help strengthen the safety monitoring of medicines across Europe. The PRAC is responsible for assessing all aspects of risk management of human medicines.

The meeting is part of a set of 20 meetings of the several Committees and Working Groups that INFARMED will be holding during the six months of the Portuguese Presidency.

This site uses cookies to enhance your experience. When you continue to browse, you are accepting You are using an outdated browser. Please, upgrade your browser to improve your experience.