Workshop on paediatric formulations for assessors in national regulatory agencies

• Date:
  Tuesday, 8 November 2011, All day
• 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

Presentation - Paediatric investigation plan assessment procedure

Presentation - Regulatory update on guidelines relevant to paediatric formulations

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

Presentation - Age-appropriate formulations – paediatric needs

Presentation - Excipients general approach

Presentation - Development of paediatric formulations - points to consider

Presentation - Experience of paediatric formulations in marketing authorisation applications

Presentation - Acceptability and palatability - methods available for assessment