Inspections and audits in Pharmacovigilance

A threat or the best way to improve your quality? 
Lecturers: Dr. Irene Fermont

Date: TBA
Location: Bioforum, Golda Meir 3, Ness Ziona.
General Information
Duration: 2 - Day Course
Hours: 09:00 – 17:00
Price: 3,300 NIS + VAT
Credit Points: 1
SKU: 19835
Course Language: English
About the Course
In 2010, the European Pharmacovigilance regulation has undergone a major transformation. The regulation has framed the scope and objectives to be reached within the next decade. Since 2010, a large number of guidelines are being issued; they provide accurate and practical recommendations on “how” to reach these objectives.
Transparency, harmonisation, preventive actions, centralisation, e-communication are the key concepts of these new regulations.
This change had a strong influence on the international and harmonised PV regulation, as seen in the Israeli MOH requirements  which clearly requests following the EU regulation, in Nohal 6 (נוהל 6) and the recent Nohal on Risk Management Plans.    
To ensure a good governance, Quality Assurance and Quality Control (QA/QC) must be applied both for Competent Authorities and Industry.
A well organised program of inspections has been established by EMA, defining the inspections calendar, the prioritisation and the methodology within Europe but also worldwide, for commercial and investigational products.
Following the same approach, both, authorities and industry must set up processes and metrics to audit the PV system quality for themselves and for their partners/providers. The audit calendar is part of the PV System Master File, with both the findings and the corrective actions which have been taken following the audit.

These recommendations are highlighted in the very title of the first module of the Good Pharmacovigilance Practices: The Pharmacovigilance System and its Quality System.
Who should attend
  • Pharmacovigilance staff, QPPV, Safety Data Managers
  • Quality department staff
  • Regulatory affairs managers
  • Clinical Trials Managers


  • Pharmaceutical Manufacturers
  • Companies with products on the Israeli and the global market
  • Affiliates of pharmaceutical groups
  • Importers
  • Service Providers  
Inspections and audits in Pharmacovigilance
Benefits to the Participants
The course provides keys and methods to:
  • Set up a strong PV quality system
  • Build and maintain a PV System Master File
  • Be prepared for inspections
  • Setup a plan for CAPA – (Corrective Actions, Preventive Actions)
  • Comply with international and Israeli regulation
Contact us
  • Full Name
  • Email
  • Phone
  • Notes
  • Send
Issues to be covered
  • The virtuous circle of Quality
  • The Pharmacovigilance System Master File: a very powerful tool for quality
  • Inspections: Good Pharmacovigilance Practices (GVP) Module III
    • What triggers inspections in EMA?
    • Methodology
    • Getting ready for inspection and follow up
    • UK MHRA: examples of findings
  • Audits for industry: GVP Module IV  
    • How to prioritize?
    • Methodology
    • CAPA
    • Follow up
  • How much does it apply for Clinical Trials?
  • What 's going on in Israel?    
The course will include practical examples
About The Lecturer

Dr. Irene Fermont

Owner of IFC - Irene Fermont Strategic Safety Consulting, Paris and Jerusalem,
Physician, Immuno-Hematologist, Master of Bioengineering, European Qualified Person for Pharmacovigilance (EU-QPPV) founding member of the QPPV association, coordinator of the Israeli Chapter of ISOP (International Society of Pharmacovigilance), founding member of the ISOP working group on risk communication
Irene’s successful career in the pharmaceutical industry stretches over 20 years.
For more information please click here

Learning from us