Workshop on the development of antimicrobial medicinal products for paediatric patients

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Date: csütörtök, 21 június 2018, Egész nap
Helyszín: European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Agenda - Workshop on development of antibacterial medicinal products for paediatric patients

English (EN) (488.47 KB - PDF)

Első közzététel: 24/05/2018 Legutóbb frissítve: 29/10/2018

Presentation - Anti-infective drug development in neonates (S.Nambiar, FDA)

English (EN) (385.36 KB - PDF)

Első közzététel: 29/10/2018

Presentation - Studying neonates: A not-for-profit developers perspective (M.Balasegaram, GARDP)

English (EN) (1.22 MB - PDF)

Első közzététel: 29/10/2018

Presentation - Anti-Infectives and Neonates (D.Benjamin, Duke University)

English (EN) (558.71 KB - PDF)

Első közzététel: 29/10/2018

Presentation - Challenges in conducting trials involving children: Sponsor’s view (G. Noel; S.Cammarata)

English (EN) (662.45 KB - PDF)

Első közzététel: 29/10/2018

Presentation - General considerations for the development of antibacterial drugs for children - U.S. FDA perspective (J.Farley, FDA)

English (EN) (386.68 KB - PDF)

Első közzététel: 29/10/2018

Presentation - Issues in conducting clinical trials in children and neonates: site PI perspective (T.Metsvaht, University of Tartu)

English (EN) (4.14 MB - PDF)

Első közzététel: 29/10/2018

Presentation - Neonates need more finesse in dosing of antibiotics (K.Allegaert, KU Leuven)

English (EN) (2.87 MB - PDF)

Első közzététel: 29/10/2018

Presentation - Overview of neonatal studies in paediatric investigational plans (M.Cortizo, IDWP/PDCO)

English (EN) (169.54 KB - PDF)

Első közzététel: 29/10/2018

Presentation - Pharmacokinetic-Pharmacodynamic (PKPD) modelling to inform efficacyin paediatric antimicrobial trials (J.Standing, UCL)

English (EN) (1.65 MB - PDF)

Első közzététel: 29/10/2018

Presentation - PMDA perspective: Ongoing activities and requirements for developing antibacterial agents for children (J.Sato, PMDA)

English (EN) (2.76 MB - PDF)

Első közzététel: 29/10/2018

Presentation - Safety assessment in paediatric antibiotics clinical trials (M.Sharland, St.George's University of London)

English (EN) (1.7 MB - PDF)

Első közzététel: 29/10/2018

Presentation - Studying neonates: Workshop on development of antibacterial products for paediatric patients (M.Johnson)

English (EN) (262.61 KB - PDF)

Első közzététel: 29/10/2018

Presentation - The paediatrica ddendum to the antibacterial agents guideline (M.Fernandez Cortizo, IDWP/PDCO)

English (EN) (277.74 KB - PDF)

Első közzététel: 29/10/2018

Presentation - The right dose - Application of PK/PD modeling in pediatric antibiotic development (M.Cohen-Wolkowiez, Duke University)

English (EN) (1.86 MB - PDF)

Első közzététel: 29/10/2018