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SESSION 1: INTRODUCTION AND DEFINITIONS
Session Chair(s)
Mette Due Theilade Thomsen, PhD
CEO
PIP Adviser, Denmark
Janina Karres, PhD
Scientific Officer, Paediatric Medicines Office
European Medicines Agency, Netherlands
- EU paediatric regulation
- PIPs, waivers, deferrals, PDCO
- Guidelines and EMA website
Speaker(s)
Introduction
Mette Due Theilade Thomsen, PhD
PIP Adviser, Denmark
CEO
EU paediatric regulation
Janina Karres, PhD
European Medicines Agency, Netherlands
Scientific Officer, Paediatric Medicines Office
PIPs, waivers, deferrals, PDCO
Janina Karres, PhD
European Medicines Agency, Netherlands
Scientific Officer, Paediatric Medicines Office
Guidelines and EMA website
Janina Karres, PhD
European Medicines Agency, Netherlands
Scientific Officer, Paediatric Medicines Office
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