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European Medicines Agency

2017 年 10 月 16 日 8:00 上午 - 2017 年 10 月 17 日 4:00 下午

30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom

DIA/EFGCP/EMA Conference on How to Optimise Children’s Access to Innovative Medicines

United in the goal of increasing the availability of new medicines to paediatric patients, how can we leverage examples from past successes to overcome future barriers?

Session 5 Continued

Session Chair(s)

Janina  Karres, PhD

Janina Karres, PhD

Scientific Officer, Paediatric Medicines Office

European Medicines Agency, Netherlands

Roberto  De Lisa, MD

Roberto De Lisa, MD

Scientific Officer, Paediatric Medicines Office

European Medicines Agency, Netherlands

Speaker(s)

Georg  Schmitt, PhD

ICH S11 Guideline

Georg Schmitt, PhD

Roche Pharma Research and Early Development, F. Hoffmann-La Roche Ltd, Switzerland

Head Toxicology (Operations) and Nonclinical Paediatrics

Solange  Corriol-Rohou, DrMed, MD, PhD

Revision of the ICH E11 Guideline

Solange Corriol-Rohou, DrMed, MD, PhD

AstraZeneca , France

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe

Heidrun  Hildebrand

IMI2: Pan European Paediatric Clinical Trials Network

Heidrun Hildebrand

BAYER, Germany

Paediatric Development Alliance Manager, Paediatric Medicine; Research and De

Stefan   Pfister , MD

IMI2: Paediatric Preclinical Proof of Concept (POC) Platform

Stefan Pfister , MD

German Cancer Research Center (DKFZ) Heidelberg, Germany

Head of Division Paediatric Neurooncology

Kit B. Roes, PhD

The FP7 Advances in Small Trials dEsign for Regulatory Innovation and eXcellence (ASTERIX) project

Kit B. Roes, PhD

University Medical Center Utrecht, Netherlands

Professor of Clinical Trial Methdology

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