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

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TitleBest use of medicines legislation to bring new antibiotics to patients and combat the resistance problem
Date08/11/2013 - 08/11/2013
LocationEuropean Medicines Agency, London, UK
SummaryThis 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.

All documents

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

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