Pricing is coming soon
This is an intensive two day Pharmacovigilance training course. It will address the major aspects of Pharmacovigilance according to the EU Good PharmacoVigilance Practices (GVP) recommendations. The course will review all processes which are directly linked to the continuous assessment of the product safety profile. A key concept is common to all processes: the proactive approach of risk management, from the individual case assessment to the periodic safety update report (PSUR).
Focus & elaborate on how these changes will affect the day-to-day pharmacovigilance operations within the pharmaceutical companies with practical examples, which will be based on real life situations regarding electronic transmissions, signal management and organizational aspects affected by new draft GVP modules and the EMA's system changes.
Dr. Irene Fermont, is the leader of the Israeli Chapter of ISOP (International Society of Pharmacovigilance) dedicated to training and education. Pharmacovigilance (EU-QPPV) founding member of the QPPV association, founding member of the ISOP working group on risk communication.
Comply with EU and International Regulation
Review all processes focused on safety profile
Understand the Risk Management Approach
Coordinate & generate PSUR & RMP
Learn to write the Standard Operating Procedures (SOPs) according to GVPs requirements
Expand your global safety knowledge
Learn to apply the legislation for ensuring compliance
Set up and follow up CAPA – (Corrective Actions, PreventiveActions)
Use the PV System Master File