1. The implications for Europe of revised FDA guidelines for clinical trials with anti-infective agents;Gilbert;Eur J Clin Microbiol Infect Dis,1990
2. Draft reflection paper on the extrapolation of results from clinical studies conducted outside Europe to the EU-population,2009
3. Scientific guidelines for human medicinal products,2009
4. Guidances (drugs): clinical/antimicrobial,2009
5. Concept paper on the need for revision of the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 REV 1),2009