EMA mededeling: Workshop – Ontwikkeling van antibiotica voor kinderen – op weg naar een mondiale aanpak
The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) are co-organising a workshop to discuss the development of antibiotics for children.
The workshop will take place at EMA’s premises in London on 21-22 June 2018.
It will provide 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.
Highlights to be discussed at the workshop include:
- challenges with conducting trials in children;
- extrapolation of safety and efficacy data to optimise the involvement of children in clinical studies; and
- studies in newborn babies.
Expressions of interest to attend the event should be sent to email@example.com by 6 June 2018. Places are limited and will be allocated in a way that ensures a fair representation of all stakeholder groups and organisations.
The workshop will be broadcast live on the EMA website. More information including the workshop agenda is available by clicking here.