European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines
Date:
15/04/2016
Location:
European Medicines Agency, London, UK
The European Medicines Agency (EMA) is hosting the second EMA-Industry Stakeholders Platform meeting on paediatric medicines. This meeting will serve as stage to discuss among other topics the experience, so far, with paediatric standard paediatric-investigation plans (PIPs), the pilot on early interaction on paediatric development and changes to the summary report and electronic submission.
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Highlights of the European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines (PDF/88.44 KB)
First published: 28/06/2016
Last updated: 28/06/2016
EMA/272465/2016 -
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Agenda - European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines (PDF/95.42 KB)
First published: 06/04/2016
Last updated: 27/05/2016
EMA/43044/2016 -
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Presentation - Introduction (Marie-Helene Pinheiro) (PDF/121.01 KB)
First published: 27/05/2016
Last updated: 27/05/2016 -
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Presentation - e-Paediatrics: electronic distribution of application documents to PDCO, and of PDCO opinions and EMA decisions to applicants (Paolo Tomasi) (PDF/314.36 KB)
First published: 27/05/2016
Last updated: 27/05/2016 -
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Presentation - Early paediatric interaction meeting: initial consultation on paediatric development (PDF/179.34 KB)
First published: 27/05/2016
Last updated: 27/05/2016 -
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Presentation - European Medicines Agency/PDCO summary report for PIP / waiver applications: revision of template and use in applications (Ralf Herold) (PDF/319.01 KB)
First published: 27/05/2016
Last updated: 27/05/2016 -
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Presentation - PDCO and SAWP interactions (Cecile Ollivier) (PDF/167.54 KB)
First published: 27/05/2016
Last updated: 27/05/2016 -
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Presentation - Expert meeting on paediatric development of fixed-dose combinations for the treatment of the human immunodeficiency virus (HIV) (Thorsten Olski) (PDF/84.77 KB)
First published: 27/05/2016
Last updated: 27/05/2016 -
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Presentation - European Network of Paediatric Research at the European Medicines Agency: update on recent activities (Irmgard Eichler) (PDF/351.92 KB)
First published: 27/05/2016
Last updated: 27/05/2016