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Holiday Inn London Kensington Forum

Sep 17, 2015 8:00 AM - Sep 18, 2015 5:00 PM

97 Cromwell Road, London, SW7 4DN, United Kingdom

Paediatric Investigation Plans (PIP)

Session 2: THE PIP LIFECYCLE: PART 1

Session Chair(s)

Janina  Karres, PhD

Janina Karres, PhD

Scientific Officer, Paediatric Medicines Office

European Medicines Agency, Netherlands

Mette  Due Theilade Thomsen, PhD

Mette Due Theilade Thomsen, PhD

CEO

PIP Adviser, Denmark

Introduction: Preparation, submission, amending PIP after Day 60, opinion

Speaker(s)

Janina  Karres, PhD

How to build your PIP and / or waiver request

Janina Karres, PhD

European Medicines Agency, Netherlands

Scientific Officer, Paediatric Medicines Office

Janina  Karres, PhD

Conditions / indications

Janina Karres, PhD

European Medicines Agency, Netherlands

Scientific Officer, Paediatric Medicines Office

Mette  Due Theilade Thomsen, PhD

How to answer the PDCO Request for Modifications at Day 60

Mette Due Theilade Thomsen, PhD

PIP Adviser, Denmark

CEO

Mette  Due Theilade Thomsen, PhD

Company Interactions with PDCO

Mette Due Theilade Thomsen, PhD

PIP Adviser, Denmark

CEO

Mette  Due Theilade Thomsen, PhD

Global Paediatric Plan

Mette Due Theilade Thomsen, PhD

PIP Adviser, Denmark

CEO

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Registration fee includes refreshment breaks, lunches and training course material.

This course has limited capacity. Register early!

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