戻る Agenda
SESSION 2: THE PIP LIFECYCLE: PART 1
Session Chair(s)
Janina Karres, PHD
Scientific Officer, Paediatric Medicines Office
European Medicines Agency, Netherlands
Mette Due Theilade Thomsen, PHD
CEO
PIP Adviser, Denmark
- Introduction: Preparation, submission, amending PIP after Day 60, opinion
- How to build your PIP and / or waiver request
- Conditions / indications
- How to answer the PDCO Request for Modifications at Day 60
- Company Interactions with PDCO
- Global Paediatric Plan
Speaker(s)
How to build your PIP and / or waiver request
Janina Karres, PHD
European Medicines Agency, Netherlands
Scientific Officer, Paediatric Medicines Office
Conditions / indications
Janina Karres, PHD
European Medicines Agency, Netherlands
Scientific Officer, Paediatric Medicines Office
How to answer the PDCO Request for Modifications at Day 60
Mette Due Theilade Thomsen, PHD
PIP Adviser, Denmark
CEO
Company Interactions with PDCO
Mette Due Theilade Thomsen, PHD
PIP Adviser, Denmark
CEO
Global Paediatric Plan
Mette Due Theilade Thomsen, PHD
PIP Adviser, Denmark
CEO