How to comply with international regulation on Safety in Clinical Trials?

Impacts of the new European Regulation on Clinical Trials (EU 536/2014)

יום העיון יתנהל בשפה האנגלית

הרשמה מוקדמת במחירים מוזלים 

הרשמה מוקדמת עד ה-9 ביוני 2015

הרשמה החל מה-10 ביוני 2015

1,660 ש "ח + מע "מ

1,950 ש "ח + מע "מ

תאריך: 17 יוני 2015
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: יום לימודים מלא
שעות:  09:00-17:00
עלות: 1950 ש"ח + מע"מ, עד 9 ביוני: 1,660 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 15666
שפת הקורס: אנגלית
על הקורס

A large and increasing number of products are withdrawn from the market for safety reasons in the first 5 years after their approval. In addition, clinical studies are larger, involving many countries inside and outside of EU and US.

Therefore the international bodies have set up a list of principles so that all regions should apply the same methods for patients’ safety and data consistency and quality. To that purpose, harmonisation between Pharmacovigilance regulations became necessary and is increasing not only between regions but also between clinical trials and post marketing era.

ICH (International Conference of Harmonisation- USA, EU and Japan) , as well as CIOMS ( WHO working group) have both set up the international rules under which all stakeholders should organise the safety surveillance of their products before and after their approval .

FDA has adopted in 2010 the “Final Rule on IND safety reporting” with a claimed objective to be closer to ICH guidelines.

While in EU, in the frame work of a wide revision of all Pharmacovigilance regulations, EMA has adopted a new regulation (536/2014) in 2014. However the management of adverse events in clinical trials was addressed in anticipation in 2011, in the guidance CT3.

After the recommendations of the CIOMS IV group, the ICH recommendations have finally been adopted in 2011 by the three main regions simultaneously (EU, US and Japan), to harmonise the annual safety reports in clinical trials. The DSUR is a new approach to analyse the safety data of all clinical trials with the same IMP (Investigational Medicinal Product). DSUR requires a complete change of previous practices in order to coordinate and compile all the safety data, including the post marketing data.

All these regulations have common messages, the main ones being:

  • Safety is a medical activity
  • Sponsors must set up a Pharmacovigilance system with same methods and tools than post marketing Pharmacovigilance
  • Risk management and risk minimization should start at early phase of development
  • Data transparency and accessibility are required 
קהל היעד
  • Companies with ongoing Clinical Trials in Israel and outside of Israel
  • Affiliates of pharmaceutical groups with Israeli sites of multicentre studies
  • CROs
  • Academic sponsors
    • Pharmacovigilance: Local Pharmacovigilance Manager, EU QPPV, Local QP, Safety Managers, Safety Officers, Safety Data Managers
    • Regulatory affairs managers
    • Medical Directors, Projects Managers
How to comply with international regulation on Safety in Clinical Trials?
התועלת שתופק

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

  • Comply to international regulation in adverse events management
  • Coordinate and generate DSUR
  • Anticipate and set-up the needs of your Pharmacovigilance system
  • Understand Risk Management Plan approach and set up risk tables
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • What are the main principles of safety in clinical trials, as expressed in the CIOMS VI and VII recommendations?
  • What do you need to include in your processes to comply with FDA and EMA requirements on Individual cases processing?
  • DSUR, Development Safety Update Report :  highlights
  • Main changes in the new EU regulation 536/2014
  • How and when do you need to start a RMP(Risk Management Plan) ?
    • Review of the  main sections
    • How to set up a risk table
    • Applying Risk minimisation in clinical trials : case study
  • Wrap up
    • Where does Israel stand?
    • Recommendations and practical tips

The course will include practical aspects and case study of Adverse Events processing, DSUR 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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