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.

The course also examines regulatory reports such as Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR), product safety information and signal detection, interfaces with regulatory departments and with quality assurance about pharmacovigilance audits and inspections, and how to prepare for these.

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
• Electronic Submission
• MedDRA
• Clinical Trial Directive 2001/20EC
• Non-Interventional Trials
• Risk Management Plans