PAEDIATRIC MEDICINES IN EUROPE: IS IT TIME FOR REFORM?

PAEDIATRIC MEDICINES IN EUROPE: IS IT TIME FOR REFORM?

On February the 2nd 2021, the Frontiers in Medicine journal (Impact factor 3.9) published the article named ‘Paediatric Medicines in Europe: The Paediatric Regulation—Is it Time for Reform?’ The article, written by regulatory experts from the TEDDY Network, is aimed...

Enpr-EMA ASSENT/CONSENT GUIDANCE

Enpr-EMA ASSENT/CONSENT GUIDANCE

Consent requirements are not harmonised in Europe and vary according to national laws and regulations. These discrepancies can present challenges for paediatric clinical trials, especially as many are conducted as multinational trials. The Enpr-EMA working group on...

TEDDY educational activities within EJPRD

TEDDY educational activities within EJPRD

Within the European Joint Programme on Rare Diseases (EJPRD), Pillar 3 WP15, TEDDY is responsible of the preparation for the educational materials and training activities for the paediatric patients. Education of young people is essential to incorporate them as...

COVID-19: WHAT ABOUT CHILDREN AND YOUNG PEOPLE?

COVID-19: WHAT ABOUT CHILDREN AND YOUNG PEOPLE?

In full COVID-19 emergency, most scientific studies have focused their research on adult patients. New drugs, vaccines and transmissibility factors were only analysed in the case of adult patients and children and adolescents were given little consideration. As it is...

Paediatric formulation gap survey

Paediatric formulation gap survey

The WHO has initiated a comprehensive gap analysis of the most needed medicines for children in view of its upcoming review of the Essential Medicines List for children (EMLc). To support the WHO review of the Essential Medicines List for children, the Global...