Workshop on paediatric formulations for assessors in national regulatory agencies

Event

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Date

ponedeljek, 31 Maj 2010, All day

Lokacija

European Medicines Agency, Amsterdam, the Netherlands

Documents

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

Reference Number: EMA/455844/2010

English (EN) (120.57 KB - PDF)

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

Reference Number: EMA/53312/2010

English (EN) (73.38 KB - PDF)

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

English (EN) (533.04 KB - PDF)

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

English (EN) (126.42 KB - PDF)

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Presentation - FDA, EuPFI, WHO Collaborations

English (EN) (225.24 KB - PDF)

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

English (EN) (158.25 KB - PDF)

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Presentation - Paediatric formulations: The clinical perspective

English (EN) (1.19 MB - PDF)

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

English (EN) (103.41 KB - PDF)

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Presentation - Preservatives: Are they safe?

English (EN) (311.44 KB - PDF)

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Presentation - Excipients: Safe or not safe?

English (EN) (191.58 KB - PDF)

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

English (EN) (376.35 KB - PDF)

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

English (EN) (165.07 KB - PDF)

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

English (EN) (270.62 KB - PDF)

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

English (EN) (388.66 KB - PDF)

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