Annual workshop of the European network of paediatric research at EMA (Enpr-EMA)

Event Human Paediatrics

Date: Tuesday, 10 October 2023, All day
Location: Online

European Medicines Agency, Amsterdam, the Netherlands

Event summary

Enpr-EMA’s annual workshop is a unique opportunity for networks as well as other stakeholders of paediatric clinical trials, such as healthcare professionals, parents, carers, patient representatives as well as medicine developers and regulators, to learn about the network’s priority activities.
The workshop aims to facilitate inter-network and stakeholder collaboration and to build competences at European level:

Participants will have the opportunity to learn about the achievements and latest activities of Enpr-EMA and to discuss recent developments relevant to the conduct of paediatric clinical trials. This includes among other things the strengthening of the role of the paediatric research nurse, quality criteria for paediatric clinical trial sites, as well as improving the access of paediatric patients to clinical trials across borders.
The meeting will see discussions on decentralised elements in clinical trials and on the renovation of the ICH E6 guideline on Good Clinical Practice (GCP).
EMA will inform participants and seek their feedback regarding planned actions to support academic sponsors as part of the ACT EU (Accelerate Clinical Trials in the EU) initiative.
Moreover, the European Commission will present the main aspects of the proposed new EU pharmaceutical legislation relevant for paediatrics, which will provide first-hand insights and an opportunity for dialogue and discussion.
The final session of the day will focus on best practices for patient recruitment as well as involvement of patients and young people in clinical trial planning.

The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) is a network of research networks, investigators and centres with recognised expertise in performing clinical trials in children. Enpr-EMA’s main objective is to facilitate clinical trials in order to increase the availability of authorised medicines for children.

Documents

Programme of the 2023 annual workshop of the European network of paediatric research at the EMA (Enpr-EMA)

Reference Number: EMA/345059/2023

English (EN) (436.39 KB - PDF)

First published: 07/08/2023 Last updated: 05/10/2023

Report from the 2023 annual workshop of the European network of paediatric research at the EMA (Enpr-EMA)

English (EN) (308.08 KB - PDF)

First published: 17/01/2024

Presentation - Enpr-EMA annual report 2022-2023 (P. Lepola)

English (EN) (1.34 MB - PDF)

First published: 13/12/2023

Presentation - Update from Enpr-EMA off-label working group (S. de Wildt)

English (EN) (3.05 MB - PDF)

First published: 13/12/2023

Presentation - Update from Enpr-EMA working group on international collaborations (T. Lacaze)

English (EN) (5.78 MB - PDF)

First published: 13/12/2023

Presentation - Update from Enpr-EMA paediatric research nurse working group (P. Dicks)

English (EN) (636.98 KB - PDF)

First published: 13/12/2023

Presentation - Update from Enpr-EMA paediatric clinical trial site standards working group (R. Fernandes, S. Corriol-Rohou)

English (EN) (190.35 KB - PDF)

First published: 13/12/2023

Presentation - Update from Enpr-EMA working group mapping/defining existing quality criteria/standards for sites (P. Skovby)

English (EN) (362.14 KB - PDF)

First published: 13/12/2023

Presentation - Update from Enpr-EMA working group on language discrimination and cross-border access to paediatric clinical trials (B. Nafria)

English (EN) (28.03 MB - PDF)

First published: 13/12/2023

Presentation - EU recommendations on decentralised elements in clinical trials (M. Al)

English (EN) (7.76 MB - PDF)

First published: 13/12/2023

Presentation - Paediatric considerations on decentralized trials (T. Lacaze)

English (EN) (878.97 KB - PDF)

First published: 13/12/2023

Presentation - Good clinical practice - ICH E6(R3) update from ACT EU (PA4) (K. Pietsch)

English (EN) (2.84 MB - PDF)

First published: 13/12/2023

Presentation - ACT EU action plan to support non-commercial Multinational CTs (G. Capone)

English (EN) (2.37 MB - PDF)

First published: 13/12/2023

Presentation - Reform of the EU pharmaceutical legislation and its impact on paediatric medicines and orphan medicine development (F. D'Atri)

English (EN) (2.39 MB - PDF)

First published: 13/12/2023

Presentation - Highlights from Enpr-EMA networks : paediatric clinical trials need paediatric clinical trial budgets (S. Koulizakos, J. Kindblom)

English (EN) (4.48 MB - PDF)

First published: 13/12/2023

Presentation - Highlights from Enpr-EMA networks : The conect4children journey (M. Turner)

English (EN) (30.26 MB - PDF)

First published: 13/12/2023

Presentation - Enpr-EMA workplan 2023-2024 (P. Lepola, G. Egger)

English (EN) (369.96 KB - PDF)

First published: 13/12/2023

Presentation - Patients recruitment and retention : practices to improve patient recruitment from a network's perspective (M. Migdal)

English (EN) (10.71 MB - PDF)

First published: 13/12/2023

Presentation - Benefits of involving patients and young people in paediatric clinical research (B. Nafria)

English (EN) (5.92 MB - PDF)

First published: 13/12/2023

Presentation - Improve paediatric health, medicine research, and innovation by sharing children's voices with iCAN (D. Bonifazi)

English (EN) (12.39 MB - PDF)

First published: 13/12/2023

Registration

The event will be held face-to-face in Amsterdam and participants are encouraged to attend in person. For attendees unable to travel a virtual option will be available.

The deadline has been extended. We invite you to complete the registration form no later than 17 September 2023.

Registration form