פרמקוויג'ילנס
דרישות משרד הבריאות הישראלי לניהול סיכונים


הקורס מועבר בשפה אנגלית

תאריך: 9, 10 יולי 2017
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  9:00-17:00
עלות: 3,500 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 17834
שפת הקורס: אנגלית
על הקורס

Triggered by Vioxx dramatic withdrawal in 2004, Competent Authorities from EU, USA and Japan and worldwide) have required industry since 2005 to set up a Risk Management Plan (ICH E2E) for any new marketing authorisation. Since 2005, Risk Management regulation has evolved towards higher authorities’ expectancy and more commitment for industry. In EU, the module 5 of Good Pharmacovigilance Practices (GPVP) gives a detailed guidance on all sections that should be presented. Israel has joined the ICH countries and issued a new regulation requiring RMP.

Any company, affiliate/distributor of an international pharma company,  is obligated to write  RMP or to  follow the HQ RMP.

In any case, you will have

  • to analyse data from all sources, non-clinical, clinical post marketing, epidemiologic  
  • to analyse your potential and identified risks, including misuse and medication errors  
  • to understand how your product ranks in the therapeutic range and state of art practices   
  • to set up actions preventing or minimising the risks
  • to set up an educational program for the Healthcare Professionals and for the patients
  • to know how to actively and intensively collect adverse reactions
  • to design pharmaco-epidemiologic studies
  • to set up performance metrics proving efficiency of your RMP or to adapt it
  • to know how and when a signal is becoming a risk

In other words, Risk Management Plan is a change of paradigm. From a passive collection of adverse events, and a reactive action at crisis time, Regulators are now expecting from industry to be proactive and prevent the preventable adverse reactions.  It has been shown that up to 60% of the Adverse Drug Reactions could be avoided in post marketing.

This new approach has been triggered by the following analysis: 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.  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 harmonised under ICH (International Conference of Harmonisation) inspired by nuclear and aeronautic industry

The Risk Management Approach must start as early as possible at the beginning of the development to avoid dramatic misjudgements which could led to patients’ deaths and company financial burden as demonstrated in Vioxx and many other cases.    

Relying on the EU GVP and the Israeli regulation, the course will

  • explain the main concepts linked to Risk Management approach and how it is linked to the other Pharmacovigilance processes: individual cases handling, PSUR, DSUR, signal detection
  • go through all sections, and with practical examples, clarify what is expected
  • Illustrate how to classify and characterise risks
  • give examples of minimisation actions
  • review risk communication actions
  • explain the main post marketing studies, their goals, their design
  • give example of performance metrics

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
  • Clinical Trials Managers for products phase3 and high-risk products, ATMP
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 RMP
  • Write the SOPs according to GVPs and Israeli RMP procedure
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • The key concept of risk management and risk minimisation
  • Detailed review of all Risk Management Plan: main sections review and case studies
    • Risk identification and classification
    • Target patients’ epidemiology
    • Post Authorisation Safety and Efficacy Studies (PAESS)
    • Examples of Prevention / minimisation actions
    • Effectiveness of minimisation action
    • Risk communication
    • Follow up in the PSUR
    • Specific aspects of high risk products: Advanced Therapy Medicinal Products, Biologics, combination products 
  • Wrap up
    • Where does Israel stand?
    • Recommendations and practical tips
  • The course will include practical aspects and a RMP case study
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.
לפרטים נוספים אנא לחצו כאן


קורסים נוספים באותה קטגוריה
לומדים אצלנו