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

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