4th EuPFI Conference Proceedings

Plenary presentations

Welcome and Introduction

Catherine Tuleu, PhD, Chair of EuPFI, UCL School of Pharmacy, London, United Kingdom

Prof. Jörg Breitkreutz, PhD, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany


Comments on the EMA draft guideline: final steps towards a harmonized view between regulators and industry

Diana van Riet-Nales, PharmD, Co-ordinator, Section Chemical Pharmaceutical Assessment (CFB),

Medicines Evaluation Board (MEB), Bilthoven, The Netherlands


AAPS paediatric task force and its White Paper

Georgia Charkoftaki, PhD, University of Athens, School of Pharmacy, Laboratory of Biopharmaceutics

and Pharmacokinetics, Athens, Greece


Reflection on the achievements of the ‘Make Medicines Child Size’ programme: what next?'

Kris Weerasuriya, PhD, Medical Officer, Medicine Access and Rational Use (MAR), Essential Medicines and

Pharmaceutical Policies (EMP) World Health Organization (WHO), Geneva, Switzerland


Challenges and opportunities for developing pediatric products: A FDA Perspective

Mansoor A. Khan, R.Ph., PhD, Director of product quality research in the Center for Drug Evaluation

and Research at the US Food and Drug Administration, Silver Spring, United States


PK & bridging studies in pediatric drug development

Benedicte Ricci, PhD, F. Hoffmann-La Roche, Basel, Switzerland


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