European Medicines Agency workshop on antibacterials

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TitleEuropean Medicines Agency workshop on antibacterials
Date07/02/2011 - 08/02/2011
LocationEuropean Medicines Agency, London
SummaryThe workshop aims to create a forum for discussion among stakeholders - academics, regulators, industry – around the EMA antibacterials drug development guideline which is currently under revision. The ‘Guideline on the Evaluation of Medicinal Products indicated for Treatment of Bacterial Infections’ was open for public consultation last year. The workshop will look at issues related to the guideline specifically clinical development of new antibiotics in major indications and studies targeting multidrug resistant bacteria. Workshop attendance is by invitation only.

All documents

Name Language First published Last updated
Agenda - Workshop on antibacterials (English only) 2011-02-03  
Workshop on antibacterials: Report of the workshop (English only) 2011-04-26  
Presentation - Elimination of carriage (English only) 2011-04-26  
Presentation - Acute bacterial exacerbations of chronic obstructive airways disease (ABECB) (English only) 2011-04-26  
Presentation - Treatment of infections due to pan-drug resistant pathogens: Difficulties in conducting clinical trials (English only) 2011-04-26  
Presentation - Consideration of some other specific indications: Bacteraemia (English only) 2011-04-26  
Presentation - What endpoints should be used in clinical trials of hospital- and ventilator-acquired pneumonia? (English only) 2011-04-26  
Presentation - Development of drugs for skin infections (English only) 2011-04-26  
Presentation - Development of drugs for eradication of carriage (English only) 2011-04-26  
Presentation - Indications and endpoints for complicated skin and soft-tissue infections (English only) 2011-04-26  
Presentation - Development of drugs for resistant organisms (English only) 2011-04-26  
Presentation - Development of drugs for bacteraemia (English only) 2011-04-26  
Presentation - Update to the European Union guideline on antibacterial agents (English only) 2011-04-26  
Presentation - A pharmacometric-based approach to facilitate critically needed new antibiotic development (English only) 2011-04-26  
Presentation - Discussion on specific indications (English only) 2011-04-26  
Presentation - Development of drugs for hospital- and ventilator-acquired pneumonia (English only) 2011-04-26  
Presentation - Development of drugs for acute otitis media and acute bacterial sinusitis (English only) 2011-04-26  

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