European Medicines Agency workshop on the development of new medicinalproducts for the treatment of ulcerative colitis and Crohn's disease

EventCorporateMedicines

Date: Monday, 29 June 2015, All day
Location: European Medicines Agency, Amsterdam, the Netherlands

The European Medicines Agency is hosting a workshop on the development of new medicinal products for the treatment of ulcerative colitis and Crohn's disease. This workshop is intended to inform the ongoing revision of the guidelines on the development of medicinal products for the treatment of Crohn's diseaseand for the treatment of ulcerative colitis, respectively, by obtaining the most up-to-date scientific positions of experts in these clinical areas. Registration open until 6 June 2015.

Documents

Programme - European Medicines Agency workshop on the development of new medicinal products for the treatment of ulcerative colitis and Crohn’s disease

Reference Number: EMA/292143/2015

English (EN) (344.8 KB - PDF)

First published: 22/05/2015 Last updated: 22/05/2015

Invitation for expressions of interest - European Medicines Agency workshop on the development of new medicinal products for the treatment of ulcerative colitis and Crohn’s disease

Reference Number: EMA/292143/2015

English (EN) (77.13 KB - PDF)

First published: 22/05/2015 Last updated: 22/05/2015

Presentation - The European Union paediatric regulation in 5 minutes (Paolo Tomasi)

English (EN) (1010.16 KB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - Induction and maintenance of remission in IBD: Where are we coming from; Where could we go? (Geert D’Haens)

English (EN) (1.78 MB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - EMA workshop on the development of new medicinal products for the treatment of ulcerative colitis and Crohn’s disease (Elmer Schabel)

English (EN) (237.37 KB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - Similarities and discrepancies between adult and paediatric disease and differential drug effects (Frank M. Ruemmele)

English (EN) (2.65 MB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - Evaluation of treatment effect in UC and CD (children) (Nick Croft)

English (EN) (1.23 MB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - Evaluation of treatment effect in adult UC and CD (Simon Travis)

English (EN) (677.07 KB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - PDCO current approach (Chrissi Pallidis)

English (EN) (239.35 KB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - Pediatric inflammatory bowel disease clinical trials: is there a role for placebo? (Athos Bousvaros)

English (EN) (361.1 KB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - Use of Placebo in Pediatric trials in IBD (Dan Turner)

English (EN) (1.2 MB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - Alternative study designs and their suitability for paediatric development (Frank Pà©tavy)

English (EN) (131.07 KB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - Dose regimen selection for biologics in IBD (Christine Hon)

English (EN) (315.94 KB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - Extrapolation in inflammatory bowel disease (Richard Veselà½)

English (EN) (644.8 KB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - Do children need adult type trials (J. Taminiau)

English (EN) (216.18 KB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

Presentation - Molecular comparison of ulcerative colitis different in age and extent of disease by colon biopsy mRNA expression profiling (Richard Strauss)

English (EN) (775.61 KB - PDF)

First published: 09/07/2015 Last updated: 09/07/2015

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