GCP inspections in Germany and Europe following the implementation of the Directive 2001/20/EC

por Göbel, Claus, Baier, Dieter, Ruhfus, Birgit, Hundt, Ferdinand
Publicado 2009

Quality expectations and tolerance limits of trial master files (TMF) – Developing a risk-based approach for quality assessments of TMFs

por Hecht, Arthur, Busch-Heidger, Barbara, Gertzen, Heiner, Pfister, Heike, Ruhfus, Birgit, Sanden, Per-Holger, Schmidt, Gabriele B.
Publicado 2015