Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem
Date:
08/11/2013
Location:
European Medicines Agency, London, UK
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.
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Report on the event ‘Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem’ (PDF/95.46 KB)
First published: 12/12/2013
Last updated: 12/12/2013
EMA/746806/2013 -
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Agenda – Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem (PDF/77.43 KB)
First published: 26/09/2013
Last updated: 06/11/2013
EMA/291054/2013 -
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Presentation - Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem (Andrzej Rys) (PDF/185.51 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - The EU regulatory framework for new antibacterial agents (Mair Powell) (PDF/149.89 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - U.S. regulatory and economic incentives for antibiotic research and development (Amanda Jezek) (PDF/611.08 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Impact of reimbursement policies on prudent use, availability and pipeline of new antibacterials (Ad Schuurman) (PDF/558.39 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Using totality of evidence for antibiotic approval, interpretive breakpoint setting, and pediatric development (Barry Eisenstein) (PDF/679.4 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - The use of antibiotics in humans in the EU: assessing the community and hospital settings (Anna-Pelagia Magiorakos) (PDF/2.66 MB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Improving and harmonising the Summary of Product Characteristics and the conditions for use of old antibacterials (Radu Botgros) (PDF/548.8 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - One Health: coordinating prudent use of antimicrobials in human and veterinary medicine (David Mackay) (PDF/170.46 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Member State’s view on encouraging appropriate use (Hugo Hurts) (PDF/186.37 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Encouraging prudent use of antibiotics (V. J. Chave) (PDF/675.15 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - EU funded research projects and the link with authorisation of new antimicrobials (Arjon van Hengel) (PDF/1.15 MB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - The Joint Programming Initiative: translate research into policy and regulation (Herman Goossens) (PDF/1.36 MB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Industry perspective on public–private partnerships and the link between new business models and the regulatory framework (John H. Rex) (PDF/203.64 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Current involvement of European Medicines Agency in research and development and future perspectives (Marco Cavaleri) (PDF/120.38 KB)
First published: 12/11/2013
Last updated: 12/11/2013