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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
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