Training

Our Training program aims to keep medical personnel in step with the high and steadily rising quality standards in medical research. We are now offering four half-day seminars per year, and are planning to conduct one- to two-day courses in the future.

Introductory Course for Investigators According to German Medicines Act (AMG)

  • Basic legal principles of ICH-GCP
  • Declaration of Helsinki
  • Code of Conduct for Physicians
  • AMG, ICH-GCP, and GCP-V
  • The investigator`s duties
  • Duty to report to regulatory authorities
  • Evidence of qualifications
  • Informed consent of the patient
  • Study nursing responsibilities
  • Pharmacovigilance/ safety management
  • Definitions of AE, SAE, and SUSAR
  • Reporting requirements
  • Quality assurance
  • Monitoring, auditing, and inspecting

Next scheduled courses:
Please contact us if you have questions regarding planned courses.