戻る Agenda
SESSION 4: THE PIP LIFECYCLE: PART 2
Session Chair(s)
Janina Karres, PHD
Scientific Officer, Paediatric Medicines Office
European Medicines Agency, Netherlands
Mette Due Theilade Thomsen, PHD
CEO
PIP Adviser, Denmark
- PIPs after approval:
- Modifications
- Changing the scope of the PIP (”Merging & splitting”)
- MAA Validation and compliance check
Speaker(s)
Modifications
Mette Due Theilade Thomsen, PHD
PIP Adviser, Denmark
CEO
Changing the scope of the PIP (”merging & splitting”)
Janina Karres, PHD
European Medicines Agency, Netherlands
Scientific Officer, Paediatric Medicines Office
MAA Validation and compliance check
Mette Due Theilade Thomsen, PHD
PIP Adviser, Denmark
CEO