Workshop on the development of antimicrobial medicinal products for paediatric patients
Date:
21/06/2018 to 22/06/2018
Location:
European Medicines Agency, London, UK
The European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency and the United States' Food and Drug Administration co-organised this workshop to discuss the development of antibiotics for children. This provides an opportunity for international regulators to explore with medicine developers, clinicians and clinical trial investigators, clinical development plans that would allow for the timely development of antibiotics for children and discuss a regulatory pathway for their approval.
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Agenda - Workshop on development of antibacterial medicinal products for paediatric patients (PDF/488.47 KB)
First published: 24/05/2018
Last updated: 29/10/2018 -
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Presentation - Anti-infective drug development in neonates (S.Nambiar, FDA) (PDF/385.36 KB)
First published: 29/10/2018 -
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Presentation - Studying neonates: A not-for-profit developers perspective (M.Balasegaram, GARDP) (PDF/1.22 MB)
First published: 29/10/2018 -
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Presentation - Anti-Infectives and Neonates (D.Benjamin, Duke University) (PDF/558.71 KB)
First published: 29/10/2018 -
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Presentation - Challenges in conducting trials involving children: Sponsor’s view (G. Noel; S.Cammarata) (PDF/662.45 KB)
First published: 29/10/2018 -
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Presentation - General considerations for the development of antibacterial drugs for children - U.S. FDA perspective (J.Farley, FDA) (PDF/386.68 KB)
First published: 29/10/2018 -
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Presentation - Issues in conducting clinical trials in children and neonates: site PI perspective (T.Metsvaht, University of Tartu) (PDF/4.14 MB)
First published: 29/10/2018 -
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Presentation - Neonates need more finesse in dosing of antibiotics (K.Allegaert, KU Leuven) (PDF/2.87 MB)
First published: 29/10/2018 -
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Presentation - Overview of neonatal studies in paediatric investigational plans (M.Cortizo, IDWP/PDCO) (PDF/169.54 KB)
First published: 29/10/2018 -
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Presentation - Pharmacokinetic-Pharmacodynamic (PKPD) modelling to inform efficacyin paediatric antimicrobial trials (J.Standing, UCL) (PDF/1.65 MB)
First published: 29/10/2018 -
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Presentation - PMDA perspective: Ongoing activities and requirements for developing antibacterial agents for children (J.Sato, PMDA) (PDF/2.76 MB)
First published: 29/10/2018 -
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Presentation - Safety assessment in paediatric antibiotics clinical trials (M.Sharland, St.George's University of London) (PDF/1.7 MB)
First published: 29/10/2018 -
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Presentation - Studying neonates: Workshop on development of antibacterial products for paediatric patients (M.Johnson) (PDF/262.61 KB)
First published: 29/10/2018 -
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Presentation - The paediatrica ddendum to the antibacterial agents guideline (M.Fernandez Cortizo, IDWP/PDCO) (PDF/277.74 KB)
First published: 29/10/2018 -
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Presentation - The right dose - Application of PK/PD modeling in pediatric antibiotic development (M.Cohen-Wolkowiez, Duke University) (PDF/1.86 MB)
First published: 29/10/2018