EudraVigilance Training Programme

• Introduction and Available Training Courses
  
1. Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSR) for the use of Eudravigilance
   
2. EudraVigilance - electronic reporting of ICSRs training
   
3. eXtended EV Medicinal Product Dictionary (XEVMPD)
   
• XEVMPD e-learning course
  
4. EV Data Analysis System (EVDAS) Training for National Competent Authorities
   
• Available Training Dates
  
• Training FAQs
  

Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSR) to EudraVigilance

This one day training course is designed for newcomers in pharmacovigilance, in particular individuals dedicated to data entry and quality review of ICSRs. The attendees will learn about the essentials of pharmacovigilance, the format, structure and content of ICSRs as well as data quality and coding principles, which are prerequisites to comply with EU and international reporting requirements. This introductory course is strongly recommended to individuals that will be transmitting ICSRs to EudraVigilance.

At the conclusion of this course, participants should be able to:


• Understand the ICSR reporting requirements
  
• Understand the basic vocabulary of pharmacovigilance
  
• Complete properly the components of an ICSR
  
• Compare ICSR components for post-authorisation and clinical trials
  
• Identify the resources available for further guidance
  

For information about how to register with EudraVigilance please see here.

The training courses dates are accessible here.

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Last update: Tuesday, 5 July 2016.