EU Good Pharmacovigilance Practices: the guidelines for all your key processes

מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 14332
שפת הקורס: אנגלית
על הקורס

Context : Harmonisation  of the Pharmacovigilance regulation worldwide

New regulations in USA, Europe, Japan – meaning worldwide- are tremendously changing the way Pharmacovigilance and Risk Management are applied routinely in clinical trials as well as in post-marketing. Israel has joined this trend with its procedure 6 and the next regulation to come into force in June 2014.
The cost for non-compliance is so high, up to 5% of the total income of the company (EU),  that product’s safety surveillance must be in the top list of risk analysis for all entrepreneurs, chief financial officers, and investors.

In the EU, the new regulation for Post Marketing is applicable since July 2012.
At the same time, the FDA has revised its regulation on the Pharmacovigilance of clinical trials.
In a perfect synchronization, the EU, USA and Japan are following their ICH commitment (International Conference of Harmonisation) and adopted a unique format for the new annual safety report in Clinical Trials, the DSUR.  
The same process applied for the ICH new format of PSUR, renamed PBRER, was adopted in 2013, by the FDA, EMA and the Japanese Agency.
Review of all the EU Good Pharmacovigilance Practices  

Since February 2012,  the EMA  has issued 12 Good Pharmacovigilance Practices (GVP), applicable immediately after publication, describing the key processes in Pharmacovigilance.  
Each GVP provides a detailed guidance specific to the process:

  • Implementation and structure
  • Methods and tools
  • Quality assurance and metrics
  • QPPV responsibilities
  • Transparency: what, how and when the public will be aware of results from this process      
  • Role of Authorities

An interim period is taking place between 2012 and 2015, to implement the changes, step by step. Major changes are planned during this period and will affect as well the international regulatory framework including Israel, whose regulation is inspired by the EU one.

Reviewing these new guidelines and implementing the changes in your Pharmacovigilance system will be a key element of your compliance

קהל היעד

Managers who have to implement a Pharmacovigilance system, either in Clinical trials, during the Marketing Authorisation application process, or in Post-marketing.
Companies the need to comply with International regulation, and to access EU and US markets  
Companies that need to comply with current Israeli regulation and anticipate the next requirements    

  • Top management
  • Pharmacovigilance: Pharmacovigilance Managers and Directors, Safety Managers, Safety Officers, Safety Data Managers
  • QA and Regulatory affairs managers
  • Medical Directors, Projects Managers
EU Good Pharmacovigilance Practices: the guidelines for all your key processes
התועלת שתופק

  • Understand and evaluate the impact of the Pharmacovigilance new regulation
  • Understand the roots of current Israeli regulation and  prepare for the next steps
  • Analyse the European Good Pharmacovigilance Practices and identify challenges
  • Identify and set up changes in your Pharmacovigilance system and plan your resources accordingly
  • Understand the responsibilities: Headquarter vs. affiliate or partner
  • Check your compliance to the new regulations and strengthen inspection readiness
  • Understand how a good Pharmacovigilance could be the best prevention for legal risks
  • Anticipate and prepare your Risk Management Plan for the marketing authorisation dossier to the best expectations of International authoritie
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

Organisation of the PV system

  • The Regulations framework: EU Pharmacovigilance regulation: Brief overview
  • The Pharmacovigilance System Master File and Detailed Description of Pharmacovigilance System
  • Quality system of the Pharmacovigilance system
  • Audits  and inspection
  • The role of the new EMA key entity: Pharmacovigilance and Risk Assessment Committee (PRAC)
Analyse of your safety data : the risk management approach
  • An adapted and balanced risk management: prepare your risk table and your Marketing Authorization Approval
  • New rules for the processing and reporting of individual adverse reactions
  • The new Periodic Safety Update Report (PSUR/PBRER): a medical approach
  • Methodology for signal detection and management
  • New product under high surveillance: additional monitoring with black triangle
  • How to manage your risk communication
  • How to set up your risk minimisation actions and how to measure their effectiveness
  • Post-Marketing Safety and Efficacy Studies: how to use pharmaco-epidemiology studies to better understand the “real life” of your products
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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