Consult GmbH & Co. KG

 
Experts on
Good Clinical Practice
since 1993

 
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More than 20 years of experience in pharmaceutical industry
  • Organisation and management of several medical departments
  • Management of a registration department
  • Planning, management and evaluation of clinical trials and Post Marketing Surveillance (PMS/NIS), experience for more than 20 years
  • Evaluation and management of basic research projects
  • Establishing of different training manuals and training of monitors, investigators and pharmaceutical representatives
  • Organisation of scientific symposia
  • Evaluation of clinical papers and documents for acquisition of a product (indication, portfolio)
  • Medical writing (PSUR, DSUR, SmPC, PIL)
  • Meetings and discussions with regulatory authorities in Germany, Lithuania, Bahrain and Oman
  • 15 years pharmacovigilance officer in Germany
  • Several years pharmacovigilance officer for Austria and Switzerland, for Western Europe, Middle East and Far East
  • 2 years safety officer for medical devices in Germany