Quality Management

In Pharmacovigilance and clinical development regulatory conform quality management is based on the principles of quality planning (establishing of structures and planning integrated and consistent processes), quality adherence (carrying out tasks and responsibilities in accordance with quality requirements), quality control and quality assurance (monitoring and evaluation how effectively the structures and processes have been established and how effectively the processes are being carried out), and quality improvements (correcting and improving the structures and processes where necessary). I am providing support in all of these phases.

  • Process analysis
  • Preparation maintenance and update of in-house SOPs
  • Training of personnel (in-house SOPs, ICH / GCP, Clinical Trial Directive, Pharmacovigilance, etc.)
  • In-house compliance audits (SOPs, ICH / GCP, Guideline on good pharmacovigilance practices (GVP), Clinical Trial Directive, etc.)
  • Prearrangement and post-processing of audits / inspections
  • Performance of audits
  • Quality assurance and quality control (according to ICH / GCP/ GVP and in-house SOPs)
  • Adjustment of medical documents with in-house SOPs and / or regulatory requirements
  • Quality control of documents (clinical trial protocols, integrated clinical trial reports, periodic reports, etc.