Speakers:

  • Enrica Alteri, former Head of Division European Medicines Agency
  • John Alexander, Deputy Director, Division of Pediatrics and Maternal Health, Center for Drug Evaluation and Research, US FDA

Moderator:

  • Radu Botgros, Senior Scientific Officer, Specialist in Infectious Diseases, Office of Health Threats and Vaccines Strategy, European Medicines Agency

This webinar covered the regulatory considerations of risk and safety aspects in clinical development of new antibacterial therapies. Adult and paediatric requirements were discussed.

Presentation 1: Developing new antibiotics: how to optimise benefits and risks (Enrica Alteri)

  • Developing new antibiotics requires a good understanding of the current landscape: AMR, patterns of utilisations in humans and livestock. The safety profile of individual new products should be compared with that of older products, but – more importantly – should be understood against the potential benefits in resistant patients. For antibiotics, the population benefits should have a high weight, and be taken into account when developing a Risk Management Plan.

Presentation 2: Safety considerations in pediatric drug development (John Alexander)

  • John Alexander discussed the safety evaluation of antimicrobial drugs in pediatric studies in the context of US pediatric regulations. The presentation focused on general approaches to collecting safety and pharmacokinetic data for antimicrobial drugs in the pediatric population.

This live webinar including an interactive Q&A session was broadcast on 8 November.

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

Download the speakers’ slides here