Workshop on paediatric formulations for assessors in national regulatory agencies Event Add to calendar Google Calendar Apple Calendar Office365 Calendar Outlook Calendar Yahoo Calendar
Date Monday, 31 May 2010, All day Location European Medicines Agency, Amsterdam, the Netherlands Documents Report: Workshop on paediatric formulations for assessors in national regulatory agenciesReference Number: EMA/455844/2010 English (EN) (120.57 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Agenda: Workshop on paediatric formulations for assessors in national regulatory agenciesReference Number: EMA/53312/2010 English (EN) (73.38 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - Paediatric regulation: an update on submissions of paediatric investigation plans English (EN) (533.04 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - Introduction to the work of the PDCO Formulation Working Group English (EN) (126.42 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - FDA, EuPFI, WHO Collaborations English (EN) (225.24 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - Article 8 – Paediatric Regulation: Interpretation of pharmaceutical form English (EN) (158.25 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - Paediatric formulations: The clinical perspective English (EN) (1.19 MB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - Formulations for clinical trials in children: Possibilities and pitfalls? English (EN) (103.41 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - Preservatives: Are they safe? English (EN) (311.44 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - Excipients: Safe or not safe? English (EN) (191.58 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - Poorly water soluble substances: challenges, options and limitations for children English (EN) (376.35 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - Legislation and available guidance for the evaluation of PIPs (quality): Viewpoint from the EMA English (EN) (165.07 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - Completion of the development of a formulation: Requirements for compliance check vs. requirements for marketing authorisation English (EN) (270.62 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Presentation - Assessment of a MAA: Awareness of the PIP recommendation: Generic applications English (EN) (388.66 KB - PDF)First published: 05/10/2010 Last updated: 05/10/2010 View Share this page