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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
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