Date
- Wednesday, 11 October 2006
Location
- European Medicines Agency, Amsterdam, the Netherlands
Documents
EMEA Workshop on Neonates: Development of medicines for neonates needs multi-disciplinary cooperation
English (EN) (37.24 KB - PDF)
Agenda - Workshop on regulatory and scientific issues related to the Investigation of medicinal products intended for neonatal use - Neonates Workshop
English (EN) (25.32 KB - PDF)
Workshop on regulatory and scientific issues related to the Investigation of medicinal products intended for neonatal use - Neonates Workshop - Minutes
English (EN) (95.32 KB - PDF)
Workshop on regulatory and scientific issues related to the Investigation of medicinal products intended for neonatal use: Welcome and Introduction - John van den Anker
English (EN) (1.67 MB - PDF)
Lessons learnt from medicinal products used in neonates - What are the needs with regard to formulation? - J. Breitkreutz
English (EN) (2.51 MB - PDF)
Research in newborn infants. Ethical aspects, recruitment and informed consent - Pieter J.J. Sauer
English (EN) (1.27 MB - PDF)
Considerations on methodology, Study design and statistical Approaches - Gerard Pons
English (EN) (528.29 KB - PDF)
Aspects of Pharmacovigilance in Neonates - Dirk Mentzer
English (EN) (6.65 MB - PDF)