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

"I enjoyed the variety of lectures and the great presenters. The whole experience was very rewarding for me. I loved the structure of topics; it was easy and interesting to follow. I made very useful notes, and I am very sure I will use the provided slides in my future work."

Sabina Kujundzic, Pharm. D., Safety Data Associate, H. Lundbeck A/S 

"The course had very good speakers, a nice venue, friendly atmosphere, and a good mix of relevant topics."

Anna Wanland, Market Access Manager, AcuCort AB

"It was an excellent course. I particularly liked that participants were both from the industry and authorities. It really showed that we have very similar tasks and interests and that we all share the same professional language. I now have a much better insight into the whole process of pharmacovigilance across development and post-marketing."

Mona El-Sayed Hervig, Pharmacovigilance officer, Lægemiddelstyrelsen

"A comprehensive and good course. A great way to get an understanding of PV as a newcomer to the field."

Gunilla Harm, Global Safety Specialist, LEO Pharma A/S

"Skilled and charismatic lecturers. Relevant presentations and introductions tovarious fields of pharmacovigilance." 

Ann-Sofie Steen Brix, Associate Clinical Safety Professional, Novo Nordisk 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
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