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Developing antibiotics for children – medical need and regulatory challenges

25 September 2020

Download the speakers’ slides here!

Speakers:

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

Moderator: Sally Ellis (GARDP)

Phoebe’s presentation 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

The presentations were followed by a Q&A session.


This live webinar including interactive Q&A session was broadcast on 28 October 2020.

If you have questions or comments, please let us know: revive@gardp.org.

2020-12-16T14:52:20+00:00