Arbeitsgemeinschaft |  | Association for |
> Annual Meeting > Annual Meetings - Overview > Annual Meeting 2004 > Presentations 2004
Abstracts of the Annual Meeting 2004
Workshops
Workshop on the German Medicinal Act (AMG) - Supporting Material
"Kabinettsentwurf" 12th amendment to the AMG (15.10.2003, German)
Gutachterliche Stellungnahme (27.01.2004, German)
Workshop on the German Medicinal Act (AMG) - Presentations
B. Lehmann, Bruxelles (EU Com.)
European Background of the Directive 2001/20/ECEuropaeische-Hintergruende-der-Richtlinie-2001-20-EG-Lehmann.ppt (173 kB)
I. Wessler, Mainz (IEC ÄK RLP)
The new responsibilities of ethic committees (German)Die-neue-Verantwortung-der-Ethikkommission-Wessler.ppt (201 kB)
F. Hackenberger, Bonn (BfArM)
Clinical trial application at the German federal competent authority (German)Genehmigungsverfahren-bei-der-BOB-Hackenberger.ppt (232 kB)
G. Schwarz, Bonn (BfArM)
GCP inspections under new regulation (German)GCP-Inspektionen-Schwarz.ppt (127 kB)
S. Keitel, Bonn (BfArM)
The CMC part of the IMPD: Phase I trials compared to phase II/III trials (German)IMPD-CMC-Keitel.ppt (976 kB)
F. Hackenberger, Bonn (BfArM)
Adverse Event Reports after May 1, 2004 (German)SUSAR-Meldungen-Hackenberger.ppt (155 kB)
Practical considerations on clinical trial applications according the 12th amendment of the German AMG to be submitted to ethic committee and competent authority (BfArM) [German]Prkatischer-Umgang.ppt (621 kB)
Workshop Biometry
M. Reber and T. Sudhop, Bonn
Basis of Biometry - Descriptive and analytical statistics in clinical trialsWorkshop-Grundlagen-Biometrie-Reber-Sudhop.pdf (515 kB)
Page updated: 28-08-2009
