Introduction to Drug Safety and Pharmacovigilance

Learn the terminology and the basic elements of drug safety and clinical trial safety

  • 22. Jan 2018

3 days course

English

12.300,- DKK ex VAT
(app. 1.654,- EUR ex VAT)

Summary

At this 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 product safety update reports (PSUR) and drug 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.
  

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

What you will learn

  1. The basic principles and elements of pharmacovigilance
  2. The essential terminology and information sources
  3. How to use best practices in drug safety and pharmacovigilance working processes
  4. How to prepare adverse event reports and the appropriate pharmacovigilance working methods

What your company will get

  1. A safety and pharmacovigilance professional who understands the basic principles and elements of pharmacovigilance
  2. A safety and pharmacovigilance professional who can operate in a dynamic and changing environment
  3. A safety and pharmacovigilance professional who can provide valuable input to all other team members working with drug safety and pharmacovigilance
Available start dates

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call Carina Schaldemose Hansen, Digital Project Manager at + 45 39 15 09 22, or send her an email at csc@atriumcph.com.

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

Want to know more about this course?

Contact Programme Director Gitte Hornemann Møller at +45 39 15 09 20

Send an email

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