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HOW WILL THE GLOBAL NEEDS OF PAEDIATRIC DEVELOPMENT BE ADDRESSED?
Session Chair(s)
Dirk Mentzer, DrMed, MD
PDCO Chair 2013-2019; Head of Pharmacovigilance Unit
Paul-Ehrlich-Institut, Germany
Eight years after the implementation of the Regulation EU 1901/2006 = Paediatric Regulation, this piece of legislation has drastically changed the way the Pharmaceutical Industry is considering the development of new candidate medicinal products for children. Pharmaceutical industry, investigators and patients are aware that newly developed medicinal products are formulated and tested in children and it is expected to increase in the coming years. Of course the needs of the paediatric population is not restricted to the Europe. In addition, a considerable number of medicinal products are developed and manufactured by multi regional acting pharmaceutical industry. Therefore, it is important to harmonise the paediatric study program in each region to limit the number of paediatric clinical trial needed to bring the medicinal product to the market. At the same time guidance documents should facilitate the framing of medicinal product development across the regions. In this respect, Europe, US and Japan and FDA have commenced activities for updating the ICH guideline E11 with the support of all regions involved. This is to support the equal opportunities for child health in all regions.
Speaker(s)
The Next Era of ICH Paediatric Guidelines
Dirk Mentzer, DrMed, MD
Paul-Ehrlich-Institut, Germany
PDCO Chair 2013-2019; Head of Pharmacovigilance Unit
How is Convergence on Timing between EU-US Possible?
Irmgard Eichler, DrMed
European Medicines Agency, Netherlands
Senior Scientific Officer Paediatric Medicines
Which Other Areas Would Benefit from Convergence – how successful have we been to date?
Jane Moll Pedersen
Novo Nordisk A/S, Denmark
Panel Discussion
Sabine Fuerst Recktenwald, DrMed, MD
F.HOFFMANN LA ROCHE LTD, Switzerland
Principal Medical Director PHC Safety Interface Team
Panel Discussion
Solange Corriol-Rohou, DrMed, MD, PhD
AstraZeneca , France
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
Panel Discussion
Stephen P. Spielberg, MD, PhD
DIA, United States
Editor-in-Chief
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