Workshop on paediatric formulations for assessors in national regulatory agencies

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TitleWorkshop on paediatric formulations for assessors in national regulatory agencies
Date31/05/2010 - 31/05/2010
LocationLondon, UK
Summary

All documents

Name Language First published Last updated
Report: Workshop on paediatric formulations for assessors in national regulatory agencies (English only) 2010-10-05  
Agenda: Workshop on paediatric formulations for assessors in national regulatory agencies (English only) 2010-10-05  
Presentation - Paediatric regulation: an update on submissions of paediatric investigation plans (English only) 2010-10-05  
Presentation - Introduction to the work of the PDCO Formulation Working Group (English only) 2010-10-05  
Presentation - FDA, EuPFI, WHO Collaborations (English only) 2010-10-05  
Presentation - Article 8 – Paediatric Regulation: Interpretation of pharmaceutical form (English only) 2010-10-05  
Presentation - Paediatric formulations: The clinical perspective (English only) 2010-10-05  
Presentation - Formulations for clinical trials in children: Possibilities and pitfalls? (English only) 2010-10-05  
Presentation - Preservatives: Are they safe? (English only) 2010-10-05  
Presentation - Excipients: Safe or not safe? (English only) 2010-10-05  
Presentation - Poorly water soluble substances: challenges, options and limitations for children (English only) 2010-10-05  
Presentation - Legislation and available guidance for the evaluation of PIPs (quality): Viewpoint from the EMA (English only) 2010-10-05  
Presentation - Completion of the development of a formulation: Requirements for compliance check vs. requirements for marketing authorisation (English only) 2010-10-05  
Presentation - Assessment of a MAA: Awareness of the PIP recommendation: Generic applications (English only) 2010-10-05  

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