Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa)

by Hennig, Michael, Hundt, Ferdinand, Busta, Susanne, Mikus, Stefan, Sanden, Per-Holger, Sörgel, Andrea, Ruppert, Thorsten
Published 2017-01-01

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

by Hecht, Arthur, Busch-Heidger, Barbara, Gertzen, Heiner, Pfister, Heike, Ruhfus, Birgit, Sanden, Per-Holger, Schmidt, Gabriele B.
Published 2015-12-01