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.

Trainer Profile

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.

  • 1997 - She joined Leo Pharma, France as Head of Pharmacovigilance and Medical Information.
  • 2003 - She was appointed - Head of International Development by CETONIA.
  • 2005 - as EU-QPVV, she undertook the organisation of Pharmacovigilance and Medical Information for ALEXION Europe and its subsidiaries. Among many others, she wrote a European Risk Management Plan for a monoclonal antibody and successfully participated in obtaining its marketing authorisation.
  • VP - Risk Management & Pharmacovigilance at ADDS (CRO).
  • 2013 - created her own company IFC, acting as strategic consultant and proposing as well a new activity: e–Vigilance, providing of all electronic tools for Pharmacovigilance, safety databases, e-transmission, e-reporting, e logbook,  e-tracker.  

Course Key Takeaways

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

Who should Attend?

VP/ Director/ Manager/ Supervisor/ Chief/ Expert

  • Pharmacovigilance Professionals
  • Regulatory Affairs Specialists
  • Drug & Product Safety Associates
  • Clinical Safety Specialists
  • Medical Directors
  • Quality Assurance
  • Safety Evaluation
  • Medical Monitoring
  • Risk Management Planning & Development


    Pricing is coming soon

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In-house opportunity

We can come to you too! If you have a team of six or more, why not hold a private course?

For more details:

Call +44 2080687649 (United Kingdom) 
Email : inhouse@biiworld.com