Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

• Date:
  Tuesday, 20 March 2018, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This workshop, organised by the European Medicines Agency (EMA) and the European Commission, follows the publication of the Commission's ten-year report on implementation of the Paediatric Regulation and the state of paediatric medicines in the European Union. The aim is to discuss potential improvements of the implementation of the Regulation. It will explore opportunities regarding paediatric needs, timely completion of paediatric investigation plans (PIP), and processes and expectations for handling PIP applications. This workshop is a crucial step for the development of a concrete action plan to address challenges identified with medicine development for children in Europe. Invited stakeholders include patients, academia, healthcare professionals and industry. The deadline for expressions of interest is 14 February. EMA will select industry stakeholders via registered associations. The Agency will contact all selected participants on 1 March.

Documents

How to better apply the paediatric legislation to boost development of medicines for children - Report on a multi-stakeholder workshop held at EMA on Tuesday 20 March 2018

Programme - EMA/EC multi-stakeholder workshop to further improve the implementation of the paediatric regulation

AdoptedReference Number: EMA/49414/2018

Presentation - Workshop programme and objectives - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Gunter Egger)

Presentation - Topic 1 - Identification of paediatric medical needs – methodology - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

Presentation - Topic 1 - Stakeholder perspectives on the development of new methodologies BOND ERN perspective - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Luca Sangio...

Presentation - Topic 1 - Assessment of paediatric medical needs through the Dutch Paediatric Formulary - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Tjitske van der Zand...

Presentation - Topic 1 - Identification of paediatric medical needs - Drug Commission of the German Medical Association (DCGMA) - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regula...

Presentation - Topic 1 - Academia-health care professionals perspective Accelerate-SIOPE-ITCC - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Gilles Vassal, Gustave Roussy...

Presentation - Topic 1 - Industry perspective - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Marie-Yvonne Douste-Blazy)

Presentation - Topic 1 - Patients perspective: Unite 2 Cure - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

Presentation - Topic 1 - Patients perspective: PHA Europe - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Hall Skà¥ra)

Presentation - Topic 1 - Patients perspective: Eurordis- Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Virginie Hivert)

Presentation - Topic 2 - International collaborations in pediatrics: FDA and EMA growing together - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Sandra L. Kweder)

Presentation - Topic 3 - Timely completion of paediatric investigation plans (PIPs) - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

Presentation - Topic 3 - Views of networks: trial preparedness - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

Presentation - Topic 3 - Timely completion of the studies of paediatric investigation plans (PIPs): Industry perspective - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (H....

Presentation - Topic 3 - Obstacles to a timely completion of paediatric development plan studies - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

Presentation - Topic 3 - Timely completion of paediatric investigation plans (PIPs): World Duchenne Organization - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Elizabeth ...

Presentation - Topic 3 - Timely completion of paediatric investigation plans (PIPs): Clinical trial application perspective - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation ...

Presentation - Topic 4 - Improving the handling of paediatric investigation plan (PIP) applications- Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

Presentation - Topic 4 - Improving the handling of paediatric investigation plan (PIP) applications: Industry perspective - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (G...

Presentation - Topic 4 - Paediatric investigation plans (PIPs): problems and solutions - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Stephanie Laer, Jenny Walsh, Gene De...

Presentation - Topic 5 - Transparency measures - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

Presentation - Topic 5 - Clinical trial transparency - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Fergus Sweeney)

Presentation - Topic 6 - Conclusions and next steps - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Michael Berntgen)

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