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Live Webinar: GARDP/REVIVE – Developing antibiotics for children – medical need and regulatory challenges
October 28, 2020 @ 4:00 am - 5:30 am
Phoebe Williams, Sydney Children’s Hospital and University of Sydney (Australia), 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 Lutsar, University of Tartu (Estonia), 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.
To learn more, click here.