European Medicines Agency workshop on antibacterials

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Date: Mandag, 7 februar 2011, Hele dagen
Placering: 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)

Først publiceret: 04/02/2011 Senest opdateret: 04/02/2011

Workshop on antibacterials: Report of the workshop

Reference Number: EMA/257650/2011

English (EN) (176.17 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

Presentation - Elimination of carriage

English (EN) (275.48 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

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

English (EN) (43.23 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

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

English (EN) (319.19 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

Presentation - Consideration of some other specific indications: Bacteraemia

English (EN) (846.72 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

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

English (EN) (523.81 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

Presentation - Development of drugs for skin infections

English (EN) (338.71 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

Presentation - Development of drugs for eradication of carriage

English (EN) (57.91 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

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

English (EN) (927.13 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

Presentation - Development of drugs for resistant organisms

English (EN) (50.52 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

Presentation - Development of drugs for bacteraemia

English (EN) (44.36 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

Presentation - Update to the European Union guideline on antibacterial agents

English (EN) (85.01 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

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

English (EN) (98.36 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

Presentation - Discussion on specific indications

English (EN) (428.44 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

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

English (EN) (56.42 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011

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

English (EN) (51.79 KB - PDF)

Først publiceret: 26/04/2011 Senest opdateret: 26/04/2011