NEWS | BEAM Alliance


REVIVE Webinar: Developing antibiotics for children – medical need and regulatory challenges

– Phoebe Williams, Sydney Children’s Hospital and University of Sydney (Australia)
– Irja Lutsar, University of Tartu (Estonia)

Phoebe’s presentation will discuss: – Status quo – what antibiotics do we have (left) for children and babies – Where is the biggest medical need? – Challenges of clinical trials in children – the clinicians perspective – What impact will new drugs have in day-to-day practice and how does this depend on the setting (e.g. LMICs vs. high-income; community vs. hospital)?

Irja will discuss: – Clinical development of antibiotics for children; incl. new formulations of existing antibiotics including general regulatory requirements – Brief overview of the type of data required for a new antibiotic for paediatric use; i.e. PK and other data – Challenges of clinical trials in children and babies – the drug developers/regulatory perspective

Moderator: Sally Ellis (GARDP)

The presentations will be followed by a Q&A session.

Date and time: 28 October, 9:00-10:30 CET

Dedicated registration link here.