European Medicines Agency workshop on antibacterials

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Date: måndag, 7 februari 2011, Hela dagen
Plats: European Medicines Agency, Amsterdam, the Netherlands

The 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.

Documents

Agenda - Workshop on antibacterials

Reference Number: EMA/90390/2011

English (EN) (66.28 KB - PDF)

Först publicerad: 04/02/2011 Senast uppdaterad: 04/02/2011

Workshop on antibacterials: Report of the workshop

Reference Number: EMA/257650/2011

English (EN) (176.17 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Elimination of carriage

English (EN) (275.48 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Acute bacterial exacerbations of chronic obstructive airways disease (ABECB)

English (EN) (43.23 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Treatment of infections due to pan-drug resistant pathogens: Difficulties in conducting clinical trials

English (EN) (319.19 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Consideration of some other specific indications: Bacteraemia

English (EN) (846.72 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - What endpoints should be used in clinical trials of hospital- and ventilator-acquired pneumonia?

English (EN) (523.81 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Development of drugs for skin infections

English (EN) (338.71 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Development of drugs for eradication of carriage

English (EN) (57.91 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Indications and endpoints for complicated skin and soft-tissue infections

English (EN) (927.13 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Development of drugs for resistant organisms

English (EN) (50.52 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Development of drugs for bacteraemia

English (EN) (44.36 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Update to the European Union guideline on antibacterial agents

English (EN) (85.01 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - A pharmacometric-based approach to facilitate critically needed new antibiotic development

English (EN) (98.36 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Discussion on specific indications

English (EN) (428.44 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Development of drugs for hospital- and ventilator-acquired pneumonia

English (EN) (56.42 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011

Presentation - Development of drugs for acute otitis media and acute bacterial sinusitis

English (EN) (51.79 KB - PDF)

Först publicerad: 26/04/2011 Senast uppdaterad: 26/04/2011