EMA-EFPIA Information Day 2011

• Date:
  Monday, 23 May 2011, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The European Medicines Agency's one-day information meeting with the European Federation of Pharmaceutical Industries and Associations (EFPIA), covering a range of topics relevant to the Paediatric Regulation including the results of a large EFPIA survey in relation to the implementation of major provisions of the Paediatric Regulation and the interpretation of the legislation and operational aspects.

Documents

Agenda - EMA/EFPIA info day - 23 May 2011

Presentation - EMA report to the European Commission – Article 50

Presentation - EMA report on the survey of all paediatric uses of medicinal products in Europe

Presentation - Efpia survey on impact of the paediatric regulation on marketing authorization holders (Jan 2007 – Jun 2010)

Presentation - Comments and proposals on the results of the EFPIA survey

Presentation - One PIP or multiple PIPs? - EMA policy on changes in scope of PIP Decisions

Presentation - Formulations: PIPs evaluation-case studies

Presentation - EMA position on Compliance Check (including validation)

Presentation - EFPIA position on Compliance Check (including validation)

Presentation - EMA experience with Art. 46 of Regulation (EC) No 1901/2006

Presentation - Industry experience with Art. 46 of Regulation (EC) No 1901/2006