This course is based on the European guideline on GVP and is a complete training solution for all individuals that need to acquire pharmacovigilance knowledge. The GVP training can also serve as a refresher course. It is consistent with the legislation changes in EU and is suitable for everyone who needs to be up-to-date with the pharmacovigilance guidelines or is involved in drug safety, pharmacovigilance, regulatory and quality compliance. \

Learning objectives

Upon completion of this online course trainees will:

  • be able to understand the basics of Good Pharmacovigilance and the current legal regulations and guidelines;
  • have the confidence to outline the main GVP requirements related to the pharmacovigilance and risk management systems;
  • get familiar with the essential documents related to GVP and understand the essence, purpose and structure of important trial related files such as the pharmacovigilance system master file (PSMF), the periodic safety update reports (PSUR and PBRER) and study protocol
  • Definition of Pharmacovigilance;
  • Objectives of Pharmacovigilance;
  • Legal framework
  • Pharmacovigilance system and quality systems;
  • Quality objectives and principles of GVP;
  • Training of personnel for pharmacovigilance;
  • Record management and documentation;
  • Qualified person
  • Pharmacovigilance System Master File (PSMF);
  • Objectives and sections of PSMF;
  • Annexes to the PSMF;
  • Change control
  • Types of Pharmacovigilance inspections;
  • Inspection follow-up;
  • Regulatory actions and sanctions
  • Principle;
  • Objectives of Risk Management Plan;
  • Structure and Content of the Risk Management Plan
  • Definitions;
  • Collection of Reports;
  • Types of Reports;
  • Validation of Reports;
  • Time Frames
  • Overview;
  • Format of the Periodic Safety Update Report (PSUR, PBRER);
  • Content of the Periodic Safety Update Report (PSUR, PBRER);
  • Mapping Signals and Risks
  • Principles;
  • Study Protocol;
  • Format and Content of the Study Protocol