Introduction to Drug Safety and Pharmacovigilance

Summary

At this three day course, you will learn the basics about safety and pharmacovigilance in post-marketing surveillance and clinical trials. You will receive a comprehensive introduction to essential terminology and information sources as well as a thorough introduction to why and how clinical trials are performed.

Other course participants say

"The course was fantastic. The 45-minute sessions with breaks in between were great to ensure we had enough energy to absorb all the material. It provided a good introduction and overview of the entire PV landscape, both pre- and post-marketing." 

Sofie Lindholm, Pharmacovigilance Officer, Lægemiddelstyrelsen

"The speakers were skilled, well-prepared, and engaging. The presentations complemented each other and had a clear, coherent theme."

Heidi Jeannet Graff, Phamacovigilance officer, Lægemiddelstyrelsen

"Well-organised course with many interesting topics and strong presentations."

Lea Abildgaard Jensen, Research scientist, Acesion Pharma ApS

"I was so happy with this course! Now I understand PV and safety much better; perhaps only on the surface level, but it is a great intro course, preparing you for the tasks ahead."

Charlotte Dahlmann Davis, PV & Safety Senior Professional, AJ Vaccines A/S

Keywords

• Danish and European Drug Safety Regulations
• The Danish Health and Medicines Authority
• The Individual Case Report
• Clinical Trial Directive 2001/20EC
• Risk Management Plans