Date
- Friday, 4 December 2009, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
This meeting is aiming to discuss various aspects of the development, clinical use and pharmacovigilance of medicines for juvenile idiopathic arthritis and other paediatric rheumatic diseases.
Documents
Agenda - Paediatric rheumatology expert group meeting
English (EN) (96.16 KB - PDF)
Paediatric rheumatology expert group meeting - Conclusions
English (EN) (65.18 KB - PDF)
Biomarkers and clinical trials, Dr Patricia Woo
English (EN) (445.78 KB - PDF)
Design of paediatric rheumatology studies time to move to active comparator, Dr Nicolino Ruperto
English (EN) (280.96 KB - PDF)
Development of a Consolidated Pediatric Rheumatology Observational Registry, Dr Jeffrey Siegel
English (EN) (274.62 KB - PDF)
EMA guidelines, Dr Marion Haberkamp
English (EN) (132.21 KB - PDF)
Long-term PHARMacovigilance for Adverse effects in Childhood arthritis focusing on Immune modulatory drugs, Dr Nico Wulffraat
English (EN) (137.91 KB - PDF)
Paediatric Pharmacovigilance, Dr Dirk Mentzer
English (EN) (298.48 KB - PDF)
Proposal for an international registry for juvenile idiopathic arthritis patients treated with methotrexate, Dr Nicolino Ruperto
English (EN) (500.82 KB - PDF)
Role of EMA in Patient Registries, Dr Jan Petracek
English (EN) (177.61 KB - PDF)
Review of answers from experts to EMA questions, Dr Richard Vesely
English (EN) (217.19 KB - PDF)
Overview of Paediatric Investigation Plans in Paediatric Rheumatology, Dr Richard Vesely, Dr Emma Sala Soriano
English (EN) (269.27 KB - PDF)
Disclaimer
The conclusions of the Experts group, although acknowledged by the PDCO, should not considered binding for the Paediatric Committee.