Workshop on the German Medicinal Act (AMG) – Supporting Material

„Kabinettsentwurf“ 12th amendment to the AMG (15.10.2003, German)

Stellungnahme des Bundesrats (14.01.2004, German)

Gutachterliche Stellungnahme (27.01.2004, German)

Workshop on the German Medicinal Act (AMG) – Presentations

B. Lehmann, Bruxelles (EU Com.)

I. Wessler, Mainz (IEC ÄK RLP)

    F. Hackenberger, Bonn (BfArM)

    G. Schwarz, Bonn (BfArM)

    S. Keitel, Bonn (BfArM)

    • IMPD-CMC-Keitel 01.ppt(1.0 MB)
      The CMC part of the IMPD: Phase I trials compared to phase II/III trials (German)

    F. Hackenberger, Bonn (BfArM)

    • Prkatischer-Umgang 01.ppt(621 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]

    Workshop Biometry

    M. Reber and T. Sudhop, Bonn