פרמקוויג'ילנס – בחינה של בטיחות המוצר


תאריך: 17, 18 מאי 2016
מיקום הקורס: משרדי ביופורום, גולדה מאיר 3, נס ציונה. קומה 4
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 3,500 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 16939
שפת הקורס: אנגלית
על הקורס

It is widely recognized that Clinical Trials give only a partial and ideal picture of the benefit risk of the product. Once on the market, the product is prescribed to patients with multiple pathologies and concomitant drugs. Patients pay a heavy toll for the misuse and medications errors. When transitioning from thousands of patients in clinical trials to millions of patients in post-marketing, rare adverse reactions which were not foreseen, can occur.  It has been shown that up to 60% of the Adverse Drug Reactions could be avoided in post marketing .Therefore, there is a critical need to permanently assess the benefit risk of the product once in real life which is the goal of all Pharmacovigilance regulation harmonized under ICH (International Conference of Harmonization).

Pharmacovigilance has developed into a complex field with increasing regulatory requirements. New regulations have been issued by the FDA, EMA and Japan and all over the world, including Israel (procedure 6).
Since 2010, the EMA has produced a large number of Good Pharmacovigilance Practices (GVP) covering all processes, which are now the most updated reference.

International regulations have a common message:

  • Safety is a medical activity
  • Pharmacovigilance must be understood as a continuum between pre and post marketing era
  • Risk management and risk minimization should start early
  • Data transparency and accessibility are required
 

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).

Following procedure 6 (which refers to EU GVP), a new regulation on Risk Management Plan is under preparation by the Israeli MOH.

The review of the GVP will be performed both on requirements review and practical examples, case       studies.

Responsibilities of partners, affiliates, HQ will be detailed for each process.  

קהל היעד
  • Companies with products on the market, in Israel and outside of Israel
  • Affiliates of pharmaceutical groups
  • Israeli Headquarters
  • Importers  
  • Pharmacovigilance:
    • Local Pharmacovigilance Manager
    • EU QPPV
    • Local QP
    • Safety Managers
    • Safety Officers
    • Safety Data Managers
  • Regulatory affairs managers
  • Medical Directors
פרמקוויג
התועלת שתופק

The objective of the course is to provide keys and methods to:

  • Comply with international and Israeli regulation
  • Understand the Risk Management Plan approach and set up risk tables
  • Coordinate and generate PSUR and RMP
  • Write the SOPs according to GVPs and procedure 6  
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • The key concept of risk management and risk minimization
  • Detailed review of all GVP related to safety profile and benefit risk analysis
    • Risk Management Plan: main sections review and case studies
      • Risk identification and classification
      • Target patients epidemiology
      • Post Authorization Safety and Efficacy Studies (PAESS)
      • Examples of Prevention / minimisation actions
      • Effectiveness of minimization action
      • Risk communication  
    • Individual Case Safety Reports – ICSR (Adverse Drug Reactions)
      • Hands on: from receipt to submission
      • Case assessment: company comment
      • Organising Literature review for ICSR
      • Case studies
      • Main differences between ICSRin Post Marketing and Clinical Trials  
    • PSUR (Periodic Safety Update Report)
      • Sections review and case studies
      • Coordination between the different units for data retrieval
      • Link between all aggregate data reports : PSUR/DSUR/RMP
      • Link with signal detection
    • Signal detection and management
      • Sources  of signal
      • Process to set up
      • Signal management   
    • Misuse and medication errors
      • How to identify
      • How to prevent  
    • Wrap up
      • Where does Israel stand?
      • Recommendations and practical tips

The course will include practical aspects and case studies of Adverse Drug Reactions (ICSR) processing, PSUR, and RMP.

אודות המרצה

ד"ר אירן פרמונט

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 20years.
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