Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem

• Date:
  Friday, 08 November 2013
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This event is organised with the European Commission and aims to discuss regulatory options for approval of new antibacterials and actions that could be taken to increase the appropriate use of the current armamentarium. It will be an opportunity to discuss research activities for antibacterials and the impact on regulatory aspects. Participation by invitation only.

Documents

Report on the event ‘Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem’

Reference Number: EMA/746806/2013

Agenda – Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem

Reference Number: EMA/291054/2013

Presentation - Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem (Andrzej Rys)

Presentation - The EU regulatory framework for new antibacterial agents (Mair Powell)

Presentation - U.S. regulatory and economic incentives for antibiotic research and development (Amanda Jezek)

Presentation - Impact of reimbursement policies on prudent use, availability and pipeline of new antibacterials (Ad Schuurman)

Presentation - Using totality of evidence for antibiotic approval, interpretive breakpoint setting, and pediatric development (Barry Eisenstein)

Presentation - The use of antibiotics in humans in the EU: assessing the community and hospital settings (Anna-Pelagia Magiorakos)

Presentation - Improving and harmonising the Summary of Product Characteristics and the conditions for use of old antibacterials (Radu Botgros)

Presentation - One Health: coordinating prudent use of antimicrobials in human and veterinary medicine (David Mackay)

Presentation - Member State’s view on encouraging appropriate use (Hugo Hurts)

Presentation - Encouraging prudent use of antibiotics (V. J. Chave)

Presentation - EU funded research projects and the link with authorisation of new antimicrobials (Arjon van Hengel)

Presentation - The Joint Programming Initiative: translate research into policy and regulation (Herman Goossens)

Presentation - Industry perspective on public–private partnerships and the link between new business models and the regulatory framework (John H. Rex)

Presentation - Current involvement of European Medicines Agency in research and development and future perspectives (Marco Cavaleri)

Multimedia