Dr. Sylvana P. Müller

Independent consultant pre-clinical development and toxicology

I´m a preclinical development consultant with greater than 20 years of experience in preparation of in-vivo pre-clinical studies, expert statements, monitoring and audits (GPL and GCP) and managing and/or coordination of pre-clinical studies (Pharmacology, safety pharmacology, pharmacokinetics and toxicology) and small clinical trials.

Membership in following organizations:

  • DGPT (Deutsche Gesellschaft für experimentelle und klinische Pharmakologie und Toxikologie e.V.)
  • Deutsche Gesellschaft für Kardiologie – Herz- und Kreislaufforschung e.V. (German Cardiac Society)
  • DIA (Drug Information Association)
  • SPS (Safety Pharmacology Society)
  • APV (International Association for Pharmaceutical Technology)

Lectures:

  • AEs, SAEs, SUSARs & Co. Meldepflichten, Meldefristen und Meldewege von unerwünschte Ereignissen in klinischen Prüfungen (2014, 2015; FORUM Heidelberg )
  • Medizinprodukte: Multinationale klinische Prüfungen (2014, FORUM Heidelberg )
  • Medizinprodukte: FDA-Update kompakt; Qualitätsmanagement und Zulassung in den USA (2015, FORUM Heidelberg )
  • Inhouse: Medizinprodukte FDA kompakt (2015, FORUM Heidelberg)

 

NEW SERVICE


As of september 2018 we offer a new service in co-operation with Dr. Rolf Siegel, well known for many years of experience in international pharmaceutical environment:

Opens internal link in current windowAuditing/Monitoring of Clinical Studies