戻る Agenda
SESSION 4 (CONTINUED): THE PIP LIFECYCLE: PART 2
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)
Annual deferral reports
Janina Karres, PHD
European Medicines Agency, Netherlands
Scientific Officer, Paediatric Medicines Office
Rewards – Supplementary protection certificate (SPC) extension
Janina Karres, PHD
European Medicines Agency, Netherlands
Scientific Officer, Paediatric Medicines Office