2022 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)

• Date:
  Tuesday, 04 October 2022, 10:30 (CEST) - 16:00 (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

The 2022 annual meeting of the members and Coordinating Group of Enpr-EMA brought together paediatric trial networks and other stakeholders of Enpr-EMA to discuss topics of common strategic interest and to provide an update on the progress of Enpr-EMA's working groups.

Topics discussed included:

• role of academic clinical trials in paediatric drug approvals and,
• tips on how to avoid potential practical pitfalls of the Clinical Trials Regulation.

The afternoon session saw a panel discussion on Health Technology Assessment of paediatric medicines.

Documents

Agenda - 2022 annual meeting of the members and Coordinating Group of Enpr-EMA

Reference Number: EMA/564166/2022

Report from the 2022 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)

Presentation - Clinical Trials Regulation (A. Solli Karlsen)

Presentation - HTA - EU perspectives (G. Vassal)

Presentation - HTA - evidentiary challenges (A. Denburg)

Presentation - HTA - introduction (M. Berntgen, N. Hedberg)

Presentation - Report from CG 2022 (P. Lepola)

Presentation - Report from site standard workshop (G. Egger)

Presentation - Role of academic clinical trials (D. Karres)

Presentation - WG on cross-border trials (B. Nafria)

Presentation - WG on off-label evidence (S. De Wildt)

Presentation - WG on research nurses (P. Dicks)