Recording of the live webinar, broadcast on 28 October 2020:
Moderator: Sally Ellis (GARDP)
Developing antibiotics for children – medical need and regulatory challenges
In this webinar, Phoebe and Irja presented on the medical need and regulatory challenges of developing antibiotics for children.
Phoebe’s presentations discussed:
- 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 discussed:
- 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
Speakers:
- Phoebe Williams, Sydney Children’s Hospital and University of Sydney (Australia)
- Irja Lutsar, University of Tartu (Estonia)
The presentations were followed by a Q&A session.
REVIVE: [ Ссылка ]
GARDP: [ Ссылка ]
