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

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TitleMulti-stakeholder workshop to further improve the implementation of the Paediatric Regulation
Date20/03/2018 - 20/03/2018
LocationEuropean Medicines Agency, London, UK
SummaryThis 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.

All documents

Name Language First published Last updated
Programme - EMA/EC multi-stakeholder workshop to further improve the implementation of the paediatric regulation (English only) 2018-01-31 2018-04-19
Presentation - Workshop programme and objectives - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Gunter Egger) (English only) 2018-04-19  
Presentation - Topic 1 - Identification of paediatric medical needs – methodology - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (English only) 2018-04-19  
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 Sangiorgi) (English only) 2018-04-19  
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 Zanden) (English only) 2018-04-19  
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 Regulation (Martina Pitzer) (English only) 2018-04-19  
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) (English only) 2018-04-19  
Presentation - Topic 1 - Industry perspective - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Marie-Yvonne Douste-Blazy) (English only) 2018-04-19  
Presentation - Topic 1 - Patients perspective: Unite 2 Cure - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (English only) 2018-04-19  
Presentation - Topic 1 - Patients perspective: PHA Europe - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Hall Skåra) (English only) 2018-04-19  
Presentation - Topic 1 - Patients perspective: Eurordis- Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Virginie Hivert) (English only) 2018-04-19  
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) (English only) 2018-04-19  
Presentation - Topic 3 - Timely completion of paediatric investigation plans (PIPs) - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (English only) 2018-04-19  
Presentation - Topic 3 - Views of networks: trial preparedness - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (English only) 2018-04-19  
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. Hildebrand) (English only) 2018-04-19  
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 (English only) 2018-04-19  
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 Vroom) (English only) 2018-04-19  
Presentation - Topic 4 - Improving the handling of paediatric investigation plan (PIP) applications- Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (English only) 2018-04-19  
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 (Geneviève Le Visage) (English only) 2018-04-19  
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 Dempsey) (English only) 2018-04-19  
Presentation - Topic 5 - Transparency measures - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (English only) 2018-04-19  
Presentation - Topic 5 - Clinical trial transparency - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Fergus Sweeney) (English only) 2018-04-19  
Presentation - Topic 6 - Conclusions and next steps - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Michael Berntgen) (English only) 2018-04-19  

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