Workshop on paediatric formulations for assessors in national regulatory agencies

Event

Date: Tuesday, 08 November 2011
Location: European Medicines Agency, Amsterdam, the Netherlands

The general scope of this workshop is to share the experiences gained at the Paediatric Committee and the present approach in reviewing the appropriateness of paediatric formulations as part of paediatric investigation plans (PIPs). Registration closed.

Documents

Report - Workshop on paediatric formulations for assessors in national regulatory agencies

English (EN) (161.7 KB - PDF)

First published: 30/01/2012Last updated: 30/01/2012

Presentation - Paediatric investigation plan assessment procedure

English (EN) (817.06 KB - PDF)

First published: 30/01/2012Last updated: 30/01/2012

Presentation - Regulatory update on guidelines relevant to paediatric formulations

English (EN) (355.54 KB - PDF)

First published: 30/01/2012Last updated: 30/01/2012

Presentation - Draft guideline on pharmaceutical development of medicines for paediatric use

English (EN) (68.15 KB - PDF)

First published: 30/01/2012Last updated: 30/01/2012

Presentation - Age-appropriate formulations – paediatric needs

English (EN) (1.03 MB - PDF)

First published: 30/01/2012Last updated: 30/01/2012

Presentation - Excipients general approach

English (EN) (421.9 KB - PDF)

First published: 30/01/2012Last updated: 30/01/2012

Presentation - Development of paediatric formulations - points to consider

English (EN) (271.12 KB - PDF)

First published: 30/01/2012Last updated: 30/01/2012

Presentation - Experience of paediatric formulations in marketing authorisation applications

English (EN) (309.66 KB - PDF)

First published: 30/01/2012Last updated: 30/01/2012

Presentation - Acceptability and palatability - methods available for assessment

English (EN) (1.58 MB - PDF)

First published: 30/01/2012Last updated: 30/01/2012