Workshop on paediatric formulations for assessors in national regulatory agencies

• Date:
  Monday, 31 May 2010
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

Documents

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

Reference Number: EMA/455844/2010

Agenda: Workshop on paediatric formulations for assessors in national regulatory agencies

Reference Number: EMA/53312/2010

Presentation - Paediatric regulation: an update on submissions of paediatric investigation plans

Presentation - Introduction to the work of the PDCO Formulation Working Group

Presentation - FDA, EuPFI, WHO Collaborations

Presentation - Article 8 – Paediatric Regulation: Interpretation of pharmaceutical form

Presentation - Paediatric formulations: The clinical perspective

Presentation - Formulations for clinical trials in children: Possibilities and pitfalls?

Presentation - Preservatives: Are they safe?

Presentation - Excipients: Safe or not safe?

Presentation - Poorly water soluble substances: challenges, options and limitations for children

Presentation - Legislation and available guidance for the evaluation of PIPs (quality): Viewpoint from the EMA

Presentation - Completion of the development of a formulation: Requirements for compliance check vs. requirements for marketing authorisation

Presentation - Assessment of a MAA: Awareness of the PIP recommendation: Generic applications