European agencies discussed Paediatric Clinical Trials

European agencies discussed Paediatric Clinical Trials
April 16, 2021

INFARMED hosted this friday the 11th meeting under the scope of the Portuguese Presidency of the Council of the European Union. The event gathered over 50 participants of the Paediatric Committee (PDCO) of the European Medicines Agency (EMA).

During meeting the debate focused on the challenges and lessons learned in the last months regarding paediatric clinical trials. Presentations were made on the development of the voluntary harmonisation procedure in multinational paediatric clinical trial applications and on paediatric clinical trials during COVID-19 pandemic.

The participants also discussed the progress being made on the field of complement mediated diseases and products blocking complement system. There was also time to listen the position of the European Medicines Agency about the regulatory challenges associated with PIPs not containing clinical data.

INFARMED also presented and promoted a debate regarding the definition of ‘traditional’ age bands in clinical trials, proposing the introction of new criteria steming from the knowledge harnessed in recent years.

The Paediatric Committee is the European Medicines Agency's (EMA) scientific committee responsible for activities on medicines for children and to support the development of such medicines in the European Union by providing scientific expertise and defining paediatric needs. The PDCO was established in line with the Paediatric Regulation, which came into effect in 2007, to improve the health of children in Europe by facilitating the development and availability of medicines for children aged 0 to 17 years.

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.

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