Workshop on the development of antimicrobial medicinal products for paediatric patients

• Date:
  Donnerstag, 21 Juni 2018, Ganztägig
• Ort:
  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

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

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

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

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

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

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

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

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

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

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

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

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

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

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