Pediatric Drug Development – Visionary Promise Or Nightmare?
13. December 2017
SAPhS PharmaLunch
Basel, January 26, 2018
Klaus Rose, M.D., M.S., klausrose Consulting, Pediatric Drug Development & More
– Chronological age, physiology, and why children are not “therapeutic orphans”
– Medical sense in FDA/EMA-demanded pediatric studies?
– Largest systematic abuse of patients in clinical research in history?
– Challenges for clinical community, media, lawyers, Ethics Committees/IRBs
– Ways forward
– Medical sense in FDA/EMA-demanded pediatric studies?
– Largest systematic abuse of patients in clinical research in history?
– Challenges for clinical community, media, lawyers, Ethics Committees/IRBs
– Ways forward