INFARMED organized this Thursday the third meeting under the scope of the Portuguese Presidency of the Council of the European Union.
The session brought together about 50 participants which are members of the Committee for Orphan Medicinal Products (COMP). Orphan Medicinal Products are medicines to be developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious.
During the meeting, several technical and legal issues were tackled, namely, the joint evaluation of Orphan and Paediatric Regulations.
There were also two presentations about digital and innovative tools for the development of rare disease therapies. There was also the opportunity hear from experienced academics about rare neurologic diseases.
INFARMED’s Vice-President, António Faria-Vaz, opened the session restating Portugal’s aim to show its continuous support of the COMP and commited to “bringing existing synergies together” in order to reach agreed proposals.
The COMP is responsible for evaluating applications for orphan designation. In the European Union (EU), a disease is defined as rare if it affects fewer than 5 in 10,000 people across the EU.
The meeting is part of the set of 20 meetings of the several Committees and Working Groups that INFARMED will be holding during the next six months.Saber mais