European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines

• Date:
  petak, 15 travnja 2016, Cijeli dan
• Lokacija:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Highlights of the European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines

Reference Number: EMA/272465/2016

Agenda - European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines

Reference Number: EMA/43044/2016

Presentation - Introduction (Marie-Helene Pinheiro)

Presentation - e-Paediatrics: electronic distribution of application documents to PDCO, and of PDCO opinions and EMA decisions to applicants (Paolo Tomasi)

Presentation - Early paediatric interaction meeting: initial consultation on paediatric development

Presentation - European Medicines Agency/PDCO summary report for PIP / waiver applications: revision of template and use in applications (Ralf Herold)

Presentation - PDCO and SAWP interactions (Cecile Ollivier)

Presentation - Expert meeting on paediatric development of fixed-dose combinations for the treatment of the human immunodeficiency virus (HIV) (Thorsten Olski)

Presentation - European Network of Paediatric Research at the European Medicines Agency: update on recent activities (Irmgard Eichler)