PRAGMATIC REGULATION - ROLE OF GUIDELINES IN STIMULATING DEVELOPMENT OF NEW ANTIBIOTICS

Track:
Effective Antibacterials: The present and the future

Day & Time:
March 5, 11:00AM - 12:30PM

Session Number:
1102

Room Number:
G104

Type:
Session

Title:
PRAGMATIC REGULATION - ROLE OF GUIDELINES IN STIMULATING DEVELOPMENT OF NEW ANTIBIOTICS

Chair(s):
Brendan Barnes
Director, Multilateral Issues and Health Policy
EFPIA, Belgium

Description:
PRAGMATIC REGULATION - ROLE OF GUIDELINES IN STIMULATING DEVELOPMENT OF NEW ANTIBIOTICS

Presentation(s) & Speaker(s):
EMA - moving towards more pragmatic solutions
Tomas Salmonson, PhD
CHMP Chairman
MPA, Sweden

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
VP and Head of Infection, Global Medicines Development
AstraZeneca, United States