Date
- Thursday, 25 October 2012, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
This workshop's aim is to discuss aspects of the development of antibacterial medicinal products, including those targeting multiple-drug-resistant pathogens and with narrow-action spectra and discussion on specific indications. Participation is invitation-based only.
Documents
Agenda – Workshop on development of new antibacterial medicines
English (EN) (82.93 KB - PDF)
Report - Workshop on development of new antibacterial medicines
English (EN) (378.42 KB - PDF)
Presentation - Trans-Atlantic Task Force on Antimicrobial Resistance (TATFAR) (Marco Cavaleri)
English (EN) (241.12 KB - PDF)
Presentation - 2012 addendum to the EU guideline on antibacterial agents (Mair Powell)
English (EN) (206.16 KB - PDF)
Presentation - Bridging the bench to bedside divide: Optimal dosing regimens of novel antimicrobials against multi drug resistant (MDR) pathogens (George Drusano)
English (EN) (1.58 MB - PDF)
Presentation - Antibiotic development for resistant bacteria: A Pharmacometric-based solution (Paul Ambrose)
English (EN) (658.87 KB - PDF)
Presentation - Superiority and organism-specific clinical trials of anitbacterial agents (Helen Boucher)
English (EN) (665.73 KB - PDF)
Presentation - Treatment of serious infections due to multiple drug resistant (MDR) acinetobacter baumannii: Presentation of a multicenter randomised clinical trial (Riccardo Utili)
English (EN) (333.16 KB - PDF)
Presentation - Drugs for multiple drug resistant (MDR) pathogens: Issues in development (Mark Goldberger)
English (EN) (126.84 KB - PDF)
Presentation - Issues to address for a Tier B development plan (Barry Eisenstein)
English (EN) (122.3 KB - PDF)
Presentation - Issues to address for a Tier C development (Aaron Dane)
English (EN) (149.44 KB - PDF)
Presentation - Considerations in the development of beta-lactamase inhibitor combination products for multiple drug resistant (MDR) pathogens (Michael Dudley)
English (EN) (87.85 KB - PDF)
Presentation - Challenges to develop diagnostics for treatment of multiple drug resistant (MDR) pathogens (Herman Goossens)
English (EN) (1.54 MB - PDF)
Presentation - Diagnostics: A focus on use in development of drugs for multiple drug resistant (MDR) pathogens (John Rex)
English (EN) (109.93 KB - PDF)
Presentation - Guidelines HAP/VAP: Standpoint from (some) academics (Serge Kouzan)
English (EN) (801.75 KB - PDF)
Presentation - HAP-VAP (David Friedland)
English (EN) (72.14 KB - PDF)
Presentation - Clinical trials in community-acquired pneumonia (CAP) (Francesco Blasi)
English (EN) (477.46 KB - PDF)
Presentation - Community-acquired pneumonia (CAP) (Keith Barker)
English (EN) (102.07 KB - PDF)
Presentation - Bacteraemia or severe sepsis as indication? (Bart Rijnders)
English (EN) (549.12 KB - PDF)
Presentation - Development of drugs for bacteremia (Charles Knirsch)
English (EN) (87.32 KB - PDF)
Presentation - Eradication of carriage (Jan Kluytmans)
English (EN) (1.26 MB - PDF)
Presentation - Development of drugs for eradication of nasal carriage of s. aureus to reduce s. aureus infections in vulnerable surgical patients (Richard Bax)
English (EN) (87.43 KB - PDF)
Presentation - Inhaled antibiotics in non-CF (Michael Loebinger)
English (EN) (422.3 KB - PDF)
Presentation - Inhalational antibacterial regimens in non-cystic fibrosis patients (Jeff Alder)
English (EN) (123.37 KB - PDF)