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PRAGMATIC REGULATION - ROLE OF GUIDELINES IN STIMULATING DEVELOPMENT OF NEW ANTIBIOTICS
Session Chair(s)
Brendan Barnes
Director, Data Protection & IP
EFPIA, Belgium
EMA - moving towards more pragmatic solutions
Speaker(s)
EMA - moving towards more pragmatic solutions
Tomas Salmonson, DrMed, PhD
Critical Path Institute, United States
Partner
Industry Perspective: The need for predictable requirements
Laurenz Kellenberger
Basilea Pharmaceutica International , Switzerland
Case study: Getting over the regulatory hurdles with the new drug Ceftarolin
John Rex, MD
AstraZeneca, United States
Senior VP and Head of Infection, Global Medicines Development
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