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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
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
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Formas de registrarse
Registration fee includes refreshment breaks, lunches and training course material.
This course has limited capacity. Register early!