Phortas at European Network of Paediatric Research at EMA (Enpr-EMA)

Phortas‘ Director, Senior Regulatory Lead Dr. Darius-Jean Namdjou, recently attended the annual open meeting of the European Network of Paediatric Research at EMA (Enpr-EMA), held in Amsterdam in person.

The event brought together key stakeholders in the European pediatric research landscape, spanning from academic excellence centers to ethicists, regulators and industry.

Key highlights included:

• Industry case studies on up-to-date approaches to paediatric clinical trial design – with a specific focus on extrapolation and Bayesian statistical concepts

• Reflections from EMA’s Paediatric Office on the same topic, confirming EMA’s willingness and openness to discuss advanced designs

• A deep-dive analysis on paediatric clinical trial assessments under the EU CTR, showing fields of need for improved alignment between EMA’s Paediatric Committee (PDCO) and national competent authorities/ethics committees. In the analysis, half of the national Clinical Trial Applications submitted based on approved PIPs were either approved with conditions only or, for a small part, even fully rejected

• Introduction of the Principle of Responsible Inclusion of Children in the updated Declaration of Helsinki, an important step to foster the inclusion of the underrepresented paediatric population into clinical research

  
  

Phortas is committed to further strengthen paediatric clinical research in Europe and beyond.

We regularly author PIPs for EU and PSPs for US and will be happy to help defining your paediatric development strategy. Please reach out to us for support on your next paediatric development and submission.

For questions or comments, contact us at: info@phortas.com