2021 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)

• Date:
  Tuesday, 28 September 2021
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This 2021 annual meeting of the Enpr-EMA Coordinating Group and networks was held in place of the annual Enpr-EMA workshop due to the COVID-19 pandemic. 

It aimed to promote dialogue between paediatric trial networks and other Enpr-EMA stakeholders on topics of common strategic interest.

The meeting covered:

• the activities and progress made by Enpr-EMA's working groups;
• upcoming changes in the context of the Clinical Trials Regulation and the Clinical Trials Information System (CTIS);
• new initiatives aimed at using real-world evidence to contribute to clinical medicine development and access;
• an update on the review of the Paediatric and Orphan Regulations by the European Commission;
• the latest COVID-19-related developments in relation to the paediatric population.

Documents

Agenda - 2021 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)

AdoptedReference Number: EMA/439238/2021

Report - 2021 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)

Presentation - A pan-EU Paediatric Clinical Trial Network (M.Turner, IMI)

Presentation - Big Data Steering Group update (F.Domerque, EMA)

Presentation - COVID-19 Update on development of therapeutics and vaccines for paediatric use (L.Fregonese, EMA)

Presentation - Introduction to the Clinical Trials Information System (CTIS) (A.Rodriquez, EMA)

Presentation - Real-world evidence to contribute to medicine development and access (R.Herold, EMA)

Presentation - Revision of the legislations on medicines for children and rare diseases - Pharmaceutical Strategy (F.D'Atri, DG SANTE)

Presentation - Enpr-EMA Annual Report 2020-2021 (P.Lepola, Enpr-EMA)

Registration

• Registration by invitation only