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Clinical  aspects of pharmacovigilance

Drug induced liver injury (DILI)


Course
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Attention, course certificates will only be awarded to professionals working in national or regional pharmacovigilance centres.

 

Target audience

The course is based on the sections of the CIOMS consensus document most relevant to the post-marketing setting, and clinical care. We recommend this e-learning course for pharmacovigilance personnel who already have basic training and practical experience in pharmacovigilance. It is also likely to be of benefit to members of national pharmacovigilance advisory committees.

 

Course syllabus

  • What is DILI
    • Understand the meaning of DILI and be able to classify cases according to categories and severity.
  • Assessing DILI cases
    • Learn to assess DILI case reports and enter valid data on the diagnosis, severity and causality into an ICSR management system.
  • Post-marketing surveillance for DILI
    • Know the sources and nature of post-marketing surveillance data and be able to use these to build and assess case series.
  • Clinical care
    • Know and understand the different levels of advice about monitoring patients taking hepatoxic medicines and clinical manifestations of DILI that affect management.
  • Liver injury attributed to herbal and dietary supplements
    • Evaluate ICSRs of herbal and dietary supplements incorporating specific information needed for these preparations.

 

Certificate

Each lesson is followed by a quiz that must be passed to be able to move forward. A certificate is awarded when you have passed the lessons and successfully completed the full course. 

Here is the course outline:

Welcome

Practical information about the course

What is DILI? (CIOMS Chapter 1) - Lesson 1

Learn what DILI is based on CIOMS Chapter 1

Assessing DILI Cases (CIOMS Chapter 2) - Lesson 2

Learn how to assess DILI cases

Post-Marketing Surveillance for DILI (CIOMS Chapter 5) - Lesson 3

Learn about post-marketing surveillance for DILI

Clinical Care (CIOMS Chapter 6) - Lesson 4

Learn about clinical care in DILI

Liver Injury attributed to Herbal and Dietary Supplements (CIOMS Chapter 8) - Lesson 5

Learn how liver injury may be attributed to herbal and dietary supplements

Reflection exercises

Three case histories to help you understand the topics in more depth

Course evaluation and certificate

Provide your feedback here through the course evaluation and gain your certificate

Completion

The following certificates are awarded when the course is completed:

Certificate of completion ENG 2 hour
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