GVP

Free Pharmacovigilance Training

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the separate countries. The course explores the activities relating to the detection and prevention of adverse effects and problems associated with medicines.

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Why enroll in this course?

Course Syllabus

  • 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);
  • Content of the Periodic Safety Update Report (PSUR);
  • Mapping Signals and Risks;
  • Principles;
  • Study Protocol;
  • Format and Content of the Study Protocol;

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