2024 annual workshop of the European network of paediatric research at EMA (Enpr-EMA)

• Date:
  Wednesday, 02 October 2024 , 09:00 - 17:00 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

Enpr-EMA's annual workshop offers a unique platform for paediatric research networks as well as other stakeholders of paediatric clinical trials, such as health care professionals, parents, carers, patient representatives, medicine developers and regulators to gain insights into recent network activities and to learn about the latest developments supporting paediatric clinical research.

The workshop provides an open forum for discussions relevant to all stakeholders and aims to foster collaboration across networks and stakeholders, promoting clinical trials for medicines for children.

Key topics include:

• Recent network activities: Learn about the Enpr-EMA initiatives on quality criteria for paediatric clinical trial sites and on cross-border access to paediatric clinical trials; receive an introduction to new European paediatric clinical research infrastructure.
• Clinical Trial Regulation (CTR) and ethical aspects in paediatric trials: Discuss the CTR implementation, EU transparency rules and emerging ethics assessment challenges for paediatric trials and updates on the revision of the Declaration of Helsinki.
• Regulatory update: Learn about the proposed revised EU pharmaceutical legislation and its impact on paediatric medicine development, updates from the Paediatric Committee, and new methods to assess combination products (medicine/device).
• Health Technology Assessment: Focus on upcoming regulatory shifts and the use of Real-World Data, and how academia can support this effort.

Enpr-EMA, launched in 2011, comprises over 50 member organisations. Its mission is to facilitate clinical trials, ensuring greater availability of medicines for children. Information about Enpr-EMA members is available in a searchable database. For further information about the network and its activities, see Enpr-EMA.

Documents

Programme of the 2024 annual workshop of the European network of paediatric research at EMA (Enpr-EMA)

Reference Number: EMA/223162/2024

Report from the 2024 annual workshop of the European network of paediatric research at EMA (Enpr-EMA)

Presentation - Brief update: Reform of the EU pharmaceutical legislation (G. Egger)

Presentation - The COMBINE project: Interface between medicines and medicinal products (M. Lunzer)

Presentation - Update on CTR implementation, including new CTIS transparency rules (F. Scotti, L. Pioppo)

Presentation - 2.5 years of CTR and CTIS: Experiences from Academic Sponsor Institutions in the ITCC network (A. Elsinghorst)

PresentatiMechanism of action PIPs: Relevant and expected in oncology (G. Vassal)

Presentation - Non-oncological MoA based PIP – Initial Deliberations from the PDCO working group discussions (S. Scherer)

Presentation - PDCO update for Enpr-EMA (S. Benchetrit)

Presentation - Emerging ethics assessment challenges in paediatric clinical trials and revision of declaration of Helsinki - What will change? (M. A. Ribeiro)

Presentation - Enpr-EMA Annual Report 2023-2024 (P. Lepola)

Presentation - Quality criteria for paediatric clinical trial sites – an Enpr-EMA initiative (R. Fernandes, P. Skovby)

Presentation - Language discrimination and cross border access to paediatric clinical trials - working group (B. Nafria)

Presentation - Conect4children (c4c) stichting - From IHI initiative to sustainable paediatric research infrastructure (M. Turner)

Presentation - How can academia build capacity to optimise RWD collection in order to support health technology assessment in paediatrics (D. Umuhire, K. Pleuschke)

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.

We invite you to complete the registration form and submit it no later than 10 September 2024. 

• Registration form